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A Study To Evaluate Durvalumab Plus Topotecan Or Lurbinectedin In Patients With Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate whether the combination of durvalumab plus lurbinectedin can increase 6 month progression-free survival, in patients with extensive stage small cell lung cancer who have progressed after treatment with an initial combination of chemotherapy and immunotherapy.
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A Study To Compare Radiation Therapy + Immune Therapy Treatment (Atezolizumab) For Extensive Stage Small Cell Lung Cancer
Albert Lea, MN; Scottsdale/Phoenix, AZ; La Crosse, WI; Rochester, MN
The purpose of this study is to compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation ...
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Chemoradiation With Or Without Atezolizumab In Treating Patients With Limited Stage Small Cell Lung Cancer
Albert Lea, MN; Eau Claire, WI; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...
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A Study Of I-DXd In Combination With Atezolizumab With Or Without Carboplatin As First-Line Induction Or Maintenance In Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and efficacy of I-DXd in combination with immune checkpoint inhibitor atezolizumab with or without carboplatin in subjects with ES-SCLC in the first-line (1L) setting.
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DAREON™-9: A Study To Test How Well Different Doses Of BI 764532 Are Tolerated By People With Small Cell Lung Cancer When Taken Together With A Single Agent Chemotherapy
Jacksonville, FL
This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment.
The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.
Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study ...
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Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer
Jacksonville, FL
This randomized phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer. Drugs used in chemotherapy, such as carboplatin, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate, and standard chemotherapy may work better in treating patients with small cell lung cancer.
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Durvalumab+/- Tremelimumab In Combination With Platinum Based Chemotherapy In Untreated Extensive-Stage Small Cell Lung Cancer (Caspian)
Scottsdale/Phoenix, AZ
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer.
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Study Of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) In Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy In Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Jacksonville, FL; Rochester, MN
The purpose of this study is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
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BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors In Patients With Advanced Solid Tumors, Phase I Studies With Expansion Cohorts In Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) And Pancreatic Adenocarcinoma (PDA)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and tolerability of a drug called BAY 1895344 in combination with irinotecan or topotecan at different doses.
Irinotecan has already been approved by the FDA to treat pancreatic cancer while topotecan has already been approved by the FDA to treat small cell lung cancer.
Another purpose of the study is to check the level of the study drugs in your blood called pharmacokinetics or PK and to see if there are changes in levels of circulating tumor cells in your blood. To assess what effect the study ...
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Study Comparing Tarlatamab And Durvalumab Versus Durvalumab Alone In First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide And Durvalumab (DeLLphi-305)
Rochester, MN
The purpose of this study is to compare the effectiveness of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
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Study Of 225Ac-ABD147 To Establish Optimal Dose In Patients With SCLC And LCNEC Of The Lung That Previously Received Platinum-based Chemotherapy
Jacksonville, FL; Rochester, MN
The study has 2 parts, Phase 1a and Phase 1b. The goal of Phase 1a is to gather safety, PK and initial efficacy data for 225Ac-ABD147 to better understand best doses for patients with small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) of the lung following platinum-based chemotherapy.
An initial group of patients will also be given an experimental imaging agent called 111In-ABD147 to help understand where ABD147 goes in the body.
The goal of Phase 1b is to gather additional safety and efficacy data on 225Ac-ABD147 to determine the best dose and to understand how those doses affect ...
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A Study To Compare Durvalumab Vs Placebo Following Stereotactic Body Radiation Therapy In Early Stage Non-small Cell Lung Cancer Patients
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of durvalumab versus placebo following Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative Non-small Cell Lung Cancer (NSCLC).
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A Study Of Neoadjuvant/Adjuvant Durvalumab For The Treatment Of Patients With Resectable Non-small Cell Lung Cancer (AEGEAN)
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.
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A Study To Collect Medical Data And Tissue From Patients With Lung Conditions Resulting In Lung Surgery.
Rochester, MN
The purpose of this study is to collect lung tissue and blood samples from participants who undergo medically-indicated lung surgery and maintain a bank of specimens from a wide range of participants with varying types of lung disease and progressions.
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Ramucirumab Plus Pembrolizumab Vs Usual Care For Treatment Of Stage IV Or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study
Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to compare the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. I
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Phase 3 Study Of Taletrectinib Vs Placebo As An Adjuvant Therapy In ROS1 Positive NSCLC (TRUST-IV)
Rochester, MN
The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.
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Phase III Study Of Datopotamab Deruxtecan Versus Docetaxel In Previously Treated TROP2-positive Advanced Or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
Eau Claire, WI; Jacksonville, FL; Rochester, MN
TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).
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Radiotherapy To Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This study is being done to answer the following question: Can the chance of lung cancer growing or spreading be lowered by adding targeted radiotherapy to the usual combination of drugs?
This study is being done to find out if this approach is better or worse than the usual approach for lung cancer. The usual approach is defined as the care most people get for non-small cell lung cancer.
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SC16LD6.5 in Recurrent Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to assess the safety and tolerability of SC16LD6.5 at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of ...
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A Study To Explore The Mechanisms That Separate Responders Versus Non-responders To Treatment Such As Immunotherapy, Target Therapy And Chemotherapy In Lung Cancer Patients
Jacksonville, FL
The purpose of this study is to explore the underlying mechanisms that distinguishes responder versus non-responders to treatment such as immunotherapy, target therapy and chemotherapy in lung cancer and mechanisms of resistance. The information generated from this study will likely help to design the optimal strategies to improve clinical outcomes in lung cancers.
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Taletrectinib Phase 2 Global Study In ROS1 Positive NSCLC
Rochester, MN
The main purpose of the study is to evaluate safety and effectiveness of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.
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Sacituzumab Tirumotecan (MK-2870) In Combination With Pembrolizumab Versus Pembrolizumab Alone In Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
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An Adjuvant Study To Evaluate SMS001 (Paclitaxel) In Non-Small Cell Lung Cancer
Rochester, MN
This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel. Doctors want to decide an appropriate safe dose for SMS001 administration, and to see how well it works in treating lung cancer patients.
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A Study Of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody In Participants With Advanced Or Metastatic NSCLC
Rochester, MN
This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.
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A Study To Evaluate Telisotuzumab Vedotin (ABBV-399) In Subjects With Previously Treated C-Met+ Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpse of this study is to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for Telisotuzumab Vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate effectiveness in the selected population(s) (Stage 2).
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Early Integrated Telehealth Versus In-Person Palliative Care For Patients With Lung Cancer
Rochester, MN
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.
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Clinical Study Of Ivonescimab For First-line Treatment Of Metastatic NSCLC Patients
Jacksonville, FL; Rochester, MN
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
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A Study of the Safety and Effectiveness of INC280 Alone and in Combination with Erlotinib, When Compared to Chemotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer Patients with EGFR Mutation and Amplified cMET
Rochester, MN
The purpose of this study is to determine the maximum tolerated dose, the next recommended study dose, and the anti-tumor activity and safety of INC280 alone and in combination with erlotinib, when compared to standard platinum with pemetrexed chemotheapy in adult patients who have EGFR mutated and cMET amplified advanced/metastatic non-small cell lung cancer,and have acquired resistance to prior EGFR tyrosine kinase inhibitors.
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A Study To Evaluate Optune Vs. Prophylactic Cranial Irradiation (PCI) In Non-Small Cell Lung Cancer Patients
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and preliminary effectiveness of Optune®-Tumor Treating Fields (TTFields) therapy vs. Prophylactic Cranial Irradiation (PCI) in Small Cell Lung Cancer (SCLC), a common disease with a high propensity for brain metastases. Prophylactic cranial irradiation (PCI) is a standard therapy for reducing the risk of SCLC brain metastases. While PCI is associated with added survival benefit to patients with SCLC, the approach is associated with both acute and long-term toxicity. As an alternative treatment option, directed electrical fields to the brain using the Optune® device is associated with decreasing the risk of tumor progression ...
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Profiling Of Lung Cancer For Identification Of Treatment Targets And Strategies
Jacksonville, FL
The purpose of this research trail is to study the genetic alteration/mutation and immune profiling in surgical resected Non-small Cell Lung Cancer (NSCLC) tumor samplesand to investigate the correlation between genetic alteration/mutation status and tumor immune micro-environment.
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Study Of Oraxol And Pembrolizumab In Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine dose escalation of paclitaxel administered as Oraxol in combination with Pembrolizumab, and dose expansion to assess the ORR per Response Evaluation Criteria in subjects with advanced Solid Tumors, Urothelial Carcinoma, Gastric cancer, Gastro-esophageal cancer, and Non-small cell lung cancer.
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Study Of DS-1062a In Advanced Or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, pharmacokinetics (PK), and safety of DS-1062a in subjects with advanced or metastatic NSCLC with known actionable genomic alterations (i.e., alterations in genes with approved therapies, such as EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, and RET) and that has progressed on or after 1 or more kinase inhibitors and platinum-based chemotherapy.
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A Study To Evaluate Screening Biomarkers For Lung Cancer
Jacksonville, FL
The purpose of this study is to evaluate new and complementary analytical MS technologies to identify and define the metabolic biomarkers for lung cancer.
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A Study Of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab In Participants With Non-small Cell Lung Cancer (V940-002)
Jacksonville, FL
The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
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A Study Of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy For Advanced Non-Small Cell Lung Cancer (MK-3475-495)
Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with MK-4280 or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-4280 or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with ...
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Study Of Datopotamab Deruxtecan (Dato-DXd) In Combination With Durvalumab And Carboplatin For First-Line Treatment Of Patients With Advanced NSCLC Without Actionable Genomic Alterations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
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A Study Of Selpercatinib Following Definitive Locoregional Treatment In Participants With Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to compare Event-Free Survival (EFS) of participants in the primary analysis population with Stage II-IIIA RET fusion-positive Non-small Cell Lung Cancer (NSCLC) treated with selpercatinib versus placebo.
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Durvalumab And Grid Therapy For The Treatment Of Non-small Cell Lung Cancer In Patients Who Progressed During Or After Treatment With The PACIFIC Regimen
Rochester, MN
The purpose of this study is to determine whether combining grid therapy at the time of disease progression during durvalumab administration or shortly after durvalumab discontinuation may permit patients to continue on durvalumab which was otherwise effective at preventing polymetastatic disease.
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Study Of VS-6766 + Adagrasib In KRAS G12C NSCLC Patients
Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and effectiveness of Avutometinib combined with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.
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Study Of Pembrolizumab With Ipilimumab Or Placebo In Participants With Untreated Metastatic Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.
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Testing The Addition Of The Drug Atezolizumab To The Usual Radiation Treatment For Patients With Early Non-small Cell Lung Cancer
La Crosse, WI
This trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy ...
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A Study To Evaluate The Addition Of Immunotherapy Into Adjuvant Therapy For Non-small Cell Lung Cancer
Rochester, MN
This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by ...
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Erlotinib with or without Bevacizumab in Treating Patients with Stage IV Non-Small Cell Lung Cancer with EGFR Mutations
Rochester, MN
This randomized phase II trial studies how well giving erlotinib (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. It is not yet known whether erlotinib is more effective when given alone or with bevacizumab.
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A Dose Escalation Study Of Amivantamab In Participants With Advanced Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the safety and pharmacokinetics, establish a recommended phase 2 dose (RP2D) regimen, and to assess the preliminary effectiveness of JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).
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A Study To Evaluate Immunotherapy For Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objectives of this study are to evaluate safety/tolerability and immunogenicity of IMU-201 as monotherapy and in combination with an immune checkpoint inhibitor (ICI) or an ICI and chemotherapy in participants with advanced NSCLC tumors that are positive for PD-L1, and to identify the Optimal Biological Dose (OBD) of IMU-201 as monotherapy and in combination with an ICI, or an ICI and chemotherapy, in participants with advanced NSCLC tumors that are positive for PD-L1.
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A Study Of Multiple Therapies In Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria.
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Shared Decision-Making Encounter Tool For Decisions Of Adjuvant Treatment In Patients With Resected Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding options for adjuvant treatment in patients with resected Non-Small Cell Lung Cancer.
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A Study To Evaluate Docetaxel With Or Without Bintrafusp Alfa To Treat Patients With Advanced Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) of docetaxel in combination with bintrafusp alfa vs. docetaxel alone.
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A Study Of Poziotinib In Patients With NSCLC With EGFR Or HER2 Exon 20 Insertion Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the efficacy and the safety/tolerability of poziotinib in patients with NSCLC exon 20 insertion mutations.
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Combination Therapies With Adagrasib In Patients With Advanced NSCLC With KRAS G12C Mutation
Jacksonville, FL; Rochester, MN
The purpoes of this study is to evaluate the clinical effectiveness of combination therapies with adagrasib in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with TPS ≥ 1% and KRAS G12C mutation
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A Study Of Multiple Therapies In Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria.
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Shared Decision-Making Encounter Tool For Decisions Of Adjuvant Treatment In Patients With Resected Non-Small Cell Lung Cancer
Rochester, MN
The purpose of this study is to develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding options for adjuvant treatment in patients with resected Non-Small Cell Lung Cancer.
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A Study To Evaluate Docetaxel With Or Without Bintrafusp Alfa To Treat Patients With Advanced Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the progression-free survival (PFS) of docetaxel in combination with bintrafusp alfa vs. docetaxel alone.
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A Study Of Poziotinib In Patients With NSCLC With EGFR Or HER2 Exon 20 Insertion Mutation
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the efficacy and the safety/tolerability of poziotinib in patients with NSCLC exon 20 insertion mutations.
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Combination Therapies With Adagrasib In Patients With Advanced NSCLC With KRAS G12C Mutation
Jacksonville, FL; Rochester, MN
The purpoes of this study is to evaluate the clinical effectiveness of combination therapies with adagrasib in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with TPS ≥ 1% and KRAS G12C mutation
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A Study Of Patients Undergoing Neoadjuvant Therapy For Resectable Non-small Cell Lung Cancer To Evaluate Perioperative Circulating Tumor DNA As A Prognostic Biomarker
Jacksonville, FL
The purpose of this study is to determine the validity of employing quantitative ctDNA as a surrogate marker for pathologic treatment response in patients receiving neoadjuvant therapy for Stage IIA-IIIB NSCLC undergoing curative-intent resection. We will assess the relationship between major pathologic response (≤10% viable tumor remaining) and percent change in levels of ctDNA concentration before and after neoadjuvant therapy.
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A Study To Evaluate Firstline Pembrolizumab Alone Or In Combination With Pemetrexed And Carboplatin In Induction/Maintenance Or Postprogression In Treating Patients With Stage IV Non-squamous Non-small Cell Lung Cancer
Albert Lea, MN; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN
The purpose of this study is to evaluate whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression, is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of ...
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A Tool For Improving The Shared Decision-making Process In Patients With Non-small Cell Lung Cancer
Rochester, MN
The purpose of this study is to use the shared decision-making (SDM) tool in clinical conversations to test whether these SDM tools affect patient understanding, treatment fidelity, or outcomes in patients with lung cancer.
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A Global Phase III Study Of Rilvegostomig Or Pembrolizumab Plus Chemotherapy For First-Line Treatment Of Metastatic Non-squamous NSCLC
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.
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Neoadjuvant Dual Checkpoint Blockade With PD1 And LAG-3 Inhibition In Resectable Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is toassess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 1-49%, as measured by rate of major pathologic response (MPR) (defined as ≤ 10% viable tumor cells in resected tumor and lymph nodes. To assess efficacy of neoadjuvant cemiplimab and fianlimab in patients with resectable/early-stage NSCLC with PD-L1 ≥50%, as measured by rate of major pathologic response (MPR).
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A Study Of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy In Patients With Resectable Stage II, IIIA, Or Select IIIB Non-Small Cell Lung Cancer (IMpower030)
Rochester, MN
This is a randomized, double-blinded study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best supportive care and monitoring.
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A Study Of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) In Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel In Participants With Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)
Scottsdale/Phoenix, AZ
This randomized Phase III, multicenter, open-label study is designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin) or Arm B (Nab-Paclitaxel + Carboplatin).
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Clinical Study Of Oral CMET Inhibitor INC280 In Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer
Rochester, MN
A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.
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A Study Of BH-30643 In Subjects With Locally Advanced Or Metastatic NSCLC Harboring EGFR And/or HER2 Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.
Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643.
Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the ...
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A Study of Pharmacogenomics Results and Clinical Data of Patients with Chronic Myeloid Leukemia and Lung Cancer to Assess Current and Future Therapeutic Relevance
Rochester, MN
The goal of this study is to examine the current and (potential) future therapeutic relevance of PGx testing for a group of patients in order to improve patient clinical care at Mayo Clinic with more effective and efficient prescribing of medications.
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A Study to Explore the Effects of the Measles Virus on Tumor Immunity
Rochester, MN
The purpose of this study is to explore the effects of the measles virus on tumor immunity in a laboratory-based study.
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A Pilot, Randomized, Open-label Study Of Tumor Treating Fields (TTFields, 150 KHz) Concomitant With Pembrolizumab For First Line Treatment Of Advanced Or Metastatic Non-small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the objective response rate (ORR) by RECIST 1.1 in subjects with TPS ≥ 1 percent.
The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Surgical Drain Fluid For Detection Of Molecular Residual Disease In Patients With Non-small Cell Lung Cancers
Rochester, MN
The purpose of this study is to characterize post-surgical drain fluid, pleural fluid, collected from the drainage device placed during surgery, as a biomarker for molecular residual disease in patients with non small cell lung cancer.
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Grid Radiation Therapy For The Treatment Of Stage IV Non-Small Cell Lung Cancer
Rochester, MN
This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size ...
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Neoadjuvant Pembrolizumab
Rochester, MN
This multi-institutional, phase 2 clinical trial is studying two doses of pembrolizumab administered prior to surgery (neoadjuvant therapy) and 4 doses administered after surgery (adjuvant therapy) for stage IB, II or IIIA non-small cell lung cancer. Pembrolizumab is a type of immunotherapy that may enhance the ability of the immune system to fight off cancer. The study will investigate the effects of pembrolizumab on the immune system and how certain immune cells, called TILs (tumor infiltrating lymphocytes), respond to pembrolizumab. Previous studies suggest that pembrolizumab could alter the immune cells in a way that the the immune cells identify cancer ...
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A Study Of Tolododekin Alfa (ANK-101) In Combination With An Anti-PD-1/PD-L1 Antibody In Participants With Advanced Non-Small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.
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A Study Of Afatinib Treatment For Patients With Epidermal Growth Factor Receptor Mutation Positive Non-Small Cell Lung Cancer, Who Are Age 70 Or Older
Scottsdale/Phoenix, AZ
The purpose of this study is to describe the occurence of adverse events which lead to the reduction in dose of afatinib in elderly patients with non-small cell lung cancer, who have common EGFR (epidermal growth factor receptor) mutations.
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A Study To Assess The Effectiveness Of Osimertinib Plus Savolitinib In Patients With Locally Advanced Or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Osimertinib Treatment (SAVANNAH Study) Following Prior Osimertinib
Rochester, MN
The purpose of this study (the SAVANNAH study) is tol investigate the effectiveness of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have progressed following treatment with osimertinib.
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A Study To Assess Efficacy And Safety Of Pembrolizumab With Or Without Sacituzumab Tirumotecan (MK- 2870) In Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Jacksonville, FL; Rochester, MN
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
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Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy In Previously Treated Advanced Or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations Or Other Genomic Alterations (MK-2870-004)
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare MK-2870 to chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations.
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A Study Comparing Sublobar Resection Versus Stereotactic Ablative Radiotherapy For Lung Cancer
Rochester, MN
The purpose of this study is to determine if Stereotactic Ablative Radiotherapy improves survival over sublobar resaction in high risk operable stage I non-small cell lung cancer.
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Anesthesia And Non-small Cell Lung Cancer Recurrence
Jacksonville, FL
There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials.
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A Study To Assess Disease Activity And Adverse Events Of Intravenous (IV) Telisotuzumab Vedotin Compared To IV Docetaxel In Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with Non-Small Cell Lung Cancer (NSCLC) who have previously been treated.
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Determining the Special Gene Expressions in Patients with Lung Cancer or Mesothelioma
Rochester, MN
This study is being done to evaluate the immune system in patients with lung cancer or mesothelioma. We are going to analyze which genes are expressed by cells that fight infections to see if there are any relations to cancer.
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A Study of the Safety and Effectiveness of Nivolumab for the Treatment of Advanced Non-Small Cell Lung Cancer
Jacksonville, FL
The purpose of this study is to determine whether nivolumab alone or in combination with standard of care therapies will provide clinical benefit without unacceptable toxicity for the treatment of advanced non-small cell lung cancer patients.
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A Platform Study In Non-Small Cell Lung Cancer (NSCLC)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
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Atezolizumab Immunotherapy In Patients With Advanced NSCLC (AJCC 7th Edition)
Scottsdale/Phoenix, AZ
Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable stage IIIA and IIIB NSCLC (AJCC 7th Edition) eligible for chemoradiotherapy with curative intent.
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A Study To Evaluate The Effect Of Canakinumab Or Pembrolizumab Given As Monotherapy Or In Combination As Neo-adjuvant Treatment For Subjects With Early Stages NSCLC
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effect of canakinumab or pembrolizumab as monotherapy or combined as neo-adjuvant treatment for subjects with early stage non-small cell lung cancer.
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Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy In Early-Stage Resectable NSCLC (VIGOR)
Rochester, MN
The purpose of this study is to evaluate the pathologic response of soft tissue ablated with Pulsed Electric Fields (PEF) in patients with non-small cell lung cancer (NSCLC) who may be candidates for resection following standard of care (SOC) neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.
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Effectiveness And Safety Of Pembrolizumab For Participants With Resectable Stage IIB Or IIIA Non-small Cell Lung Cancer
Jacksonville, FL; Rochester, MN
This trial will evaluate the safety and effectiveness of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC).
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A Study To Evaluate Durvalumab Alone Or In Combination With Novel Agents In Subjects With NSCLC
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
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Fasting Mimicking Diet For Reducing Immune Related Adverse Events For Cancer Patients On Immune Checkpoint Inhibitors, FMD-ICI Trial
Jacksonville, FL
The FMD-ICI study will utilize animal and human data that finds that fasting may promote survival mechanisms and stress resiliency. The study aims to assess the impact that a restrictive calorie diet, mostly of fat and complex carbohydrates, mimicking fasting and increasing resiliency will have in protecting patients from the adverse effects of all advanced cancer treatments which require immunotherapy. By managing the adverse side effects of ICI treatments in select cancer patients, the study will assess the effect of immunotherapy plus the Xentigen fasting mimicking diet on adverse events rates, including immune-mediated colitis. Patients will be supplied with all their dietary requirements for 4 ...
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A Global Phase III Study Of Rilvegostomig Or Pembrolizumab Plus Chemotherapy For First-Line Treatment Of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Jacksonville, FL; Rochester, MN
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
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A Registry For People With Lung Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to determine 3- and 5-year disease-free survival (DFS) among patients undergoing pulmonary segmentectomy for lung cancer. Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.
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Ph1b/2 Dose-Escalation Study Of Entinostat With Pembrolizumab In NSCLC With Expansion Cohorts In NSCLC, Melanoma, And Colorectal Cancer
Jacksonville, FL
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer
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A Study To Collect Thoracic Specimens To Develop A Thoracic Specimen Registry
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases.
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A Study Of APR-246 And Pembrolizumab In Patients With Solid Tumor Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and preliminary effectiveness of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.
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Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of AG-270 and characterize its dose-limiting toxicities (DLTs) when given daily by mouth to subjects with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).
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PF-07284892 In Participants With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.
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JSI-1187-01 Monotherapy And In Combination With Dabrafenib For Advanced Solid Tumors With MAPK Pathway Mutations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.
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A Study To Evaluate The Safety, Tolerability, And Determine The Optimal Dose For The Expansion Cohorts Of VSV-IFNβ-NIS In Combination With Pembrolizumab In Patients With Refractory Solid Tumors
Rochester, MN
The purpose of this study is to determine the safety of VSV-IFNβ-NIS in combination with pembrolizumab, followed by expansion to examine effectiveness of combination therapy in patients with refractory Non-Small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC).
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A Study Of MCLA-128 In Patients With Solid Tumors Harboring An NRG1 Fusion
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety, tolerability, movement (pharmcokinetics, "PK"), biological response (pharmacodynamics, "PD"), ability of the drug to provoke an immune response (immunogenicity) and anti-tumor activity of MCLA-128 in patients with solid tumors harboring an NRG1 fusion.
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Musical Toxicity's Effect On Patient During Cancer Treatment
Rochester, MN
The purpose of this study is to produce a rich description of musicians’ experience as they go through cancer treatment and navigate recovery.
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A Study To Assess The Safety And Tolerability Of Atezolizumab In Combination With Other Immune-Modulating Therapies In Participants With Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL
This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG−interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent ...
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Study Of BLU-667 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) And Other Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of BLU-667 administered orally in patients with medullary thyroid cancer, RET-altered NSCLC and other RET-altered solid tumors.
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Therapeutic Drug Monitoring Of Pembrolizumab And Nivolumab To Determine Dosages For Cancer Treatment
Rochester, MN
Drug monitoring of Pembrolizumaband Nivolumab for determining the pharmacokinetic (PK) profile of these medications and to provide information for dose adjustments to guide physicians in the future.
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Phase 1/2 Study Of BDTX-1535 In Patients With Glioblastoma Or Non-Small Cell Lung Cancer With EGFR Mutations
Jacksonville, FL; Rochester, MN
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma multiforme (GBM) expressing EGFR alterations (Phase 1 only). All patients will self administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 ...
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A Study To Evaluate Stereotactic Radiosurgery Versus Hippocampal-Avoidant Whole Brain Radiotherapy For 10 Or Fewer Brain Metastases From Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The primary objective of this study is to determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test – Revised (HVLT-R), Controled Oral Word Association (COWA) test, and the Trail Making Test (TMT).
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Effect Of TTFields (150 KHz) In Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)
Scottsdale/Phoenix, AZ; Jacksonville, FL
The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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Study Of Cabozantinib Alone Or In Combination With Atezolizumab To Subjects With Locally Advanced Or Metastatic Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), and non-small-cell lung cancer (NSCLC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established. In the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment ...
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A Study To Evaluate RP1 Monotherapy And Combined With Nivolumab
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the dose escalation and expansion of RP1 alone and combined with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary effectiveness.
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A Study Of The Safety And Effectiveness Of HBI-8000 With Nivolumab To Treat Melanoma, Renal Cell Carcinoma And Non-Small Cell Lung Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability and effectiveness of HBI-8000 when combined with a standard dose and regimen of nivolumab.
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A Study To Determine The Best Individualized Cancer Therapy Using Circulating Tumor DNA (CtDNA) In Patients With GI, CNS, And Thoracic Cancers.
Jacksonville, FL
This study proposes to develop and maintain a biorepository of blood samples collected from patients receiving definitive chemoradiotherapy for locally advanced rectal cancer, locally advanced pancreatic cancer, non-small cell lung cancer, or cervical cancer. The ultimate goal of this biorepository will be to provide the resource to initiate an exploration of ctDNA as a potential liquid biopsy for GI and Thoracic malignancy detection and surveillance.
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A Study To Evaluate The Safety And Efficacy Of A2B395, An Allogeneic Logic-gated CAR T, In Participants With Solid Tumors That Express EGFR And Have Lost HLA-A*02 Expression
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
* Phase 1: What is the recommended dose of A2B395 that is safe for patients
* Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells
Participants will be ...
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A Study Of CART-TnMUC1 In Patients With TnMUC1-Positive Advanced Cancers
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety, tolerability, feasibility, and preliminary effectiveness of the administration of genetically-modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
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KO-2806 Monotherapy And Combination Therapies In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.
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A Study To Investigate LYL797 In Adults With Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). The first part of the study will determine the safe dose for the next part of the study, and will enroll TNBC patients only. The second part of the study will test that dose in additional TNBC patients and NSCLC patients.
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A Study Of SGN-B7H4V In Advanced Solid Tumors
Jacksonville, FL
The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A ...
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A2B101-101: Obtaining Solid Tumor Tissue From Subjects Having Surgical Resection For Certain Tumor Types And Leukapheresis For CAR T-cell Therapy Manufacturing
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objectives for this study are:
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
Percentage of screened subjects experiencing loss ...
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A Safety Study Of SEA-TGT (SGN-TGT) In Patients With Advanced Cancer
Rochester, MN
This trial will look at a drug called SGN-TGT (an anti-TIGIT antibody) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have four groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is ...
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A Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Anti-tumor Activity Of WSD0922-FU
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).
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A Trial To Evaluate The Safety Of GEN1046 In Patients With Malignant Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors.
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A Study Of A Personalized Neoantigen Cancer Vaccine
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.
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Phase 2 Trial Of Voyager V1 In Combination With Cemiplimab In Cancer Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with Cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. Currently the study is enrolling only to the HNSCC cohort.
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A Study Of Sonidegib And Pembrolizumab In Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.
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An Investigational Immuno-therapy Study To Assess The Safety, Tolerability And Effectiveness Of Anti-LAG-3 With And Without Anti-PD-1 In The Treatment Of Solid Tumors
Rochester, MN
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
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Study Of TJ011133 In Participants With Relapsed/ Refractory Advanced Solid Tumors And Lymphoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
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JAB-3312 Based Combination Therapy In Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate the safety and tolerability of JAB-3312 in combination with anti-PD-1 mAb or MEKi or KRASi or EGFR-TKI in patients with advanced solid tumors.
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Study Of The Safety, Pharmacokinetics And Efficacy Of EDO-S101, In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
Tinostamustine (EDO-S101) is a new chemical entity, an AK-DAC (a first-in-class alkylating deacetylase inhibiting molecule) that, in preclinical studies, has been shown to simultaneously improve access to the DNA strands within cancer cells, break them and block damage repair. This Phase 1/2 study will enroll patients with various advanced solid tumors.
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The Circulating Cell-free Genome Atlas Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.
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Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.
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An Expansion Study To Evaluate Dose Escalation, Safety And Tolerability Of SAR444881 In Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in ...
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Comparison Of In-Home Versus In-Clinic Administration Of Subcutaneous Nivolumab Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program
Jacksonville, FL
This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access ...
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A Study To Evaluate Exercise For Cancer Patients At Risk Of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.
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Understanding The Challenges, Behavioral Patterns, And Preferences Towards Participation In Clinical Trials In Minority Patient Populations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.