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A Dose Escalation Study of HFB301001 (OX40 Agonist Antibody) in Adult Patients with Advanced Solid Tumors
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to characterize the safety and tolerability of single agent HFB301001 and to determine recommended dose expansino (RDE(s) and a recommended Phase 2 dose (RP2D).
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A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With MTAP Homozygous Deletion
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to to characterize the safety, tolerability, and pharmacokinetics of MRTX1719 in patients with advanced solid tumor malignancies with MTAP (methylthioadenosine phosphorylase) deletion.
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A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to characterize the safety and tolerability of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation.
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A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors
Jacksonville, Fla.
The purpose of this study is to test the safety and tolerability of HFB200301 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable dose of HFB200301 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
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A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Rochester, Minn.,
Jacksonville, Fla.
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 Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (ARTEMIDE-01)
Rochester, Minn.
The purpose of this study is to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody AZD2936 is safe, tolerable and effective in participants with Advanced or Metastatic Non-small Cell Lung Cancer.
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A081801, Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST CHEMO-IO (ALCHEMIST CHEMO-IO)
Rochester, Minn.
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 stopping them from spreading. The purpose of this trial is to find out if the addition of pembrolizumab to usual chemotherapy is better or worse than usual chemotherapy alone for non-small cell lung cancer.
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Analysis of the Dynamics of Clinical Trial Discussions in Oncology to Identify Patient Barriers and Help Develop a Patient-centered Intervention to Increase Participation in Clinical Trials
Rochester, Minn.
The purposes of this study are to richly describe the content and dynamics of clinical trial discussions in oncology and compare the knowledge, beliefs, and attitudes of oncology patients, caregivers, and clinicians related to clinical trials, and to develop a multifaceted, patient-centered intervention for increasing patient understanding of and participation in clinical trials in oncology.
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D5084C00007: A Phase II Study Assessing Efficacy of Osimertinib With Savolitinib in Patients With EGFRm MET, Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Osimertinib Treatment (SAVANNAH Study) (SAVANNAH)
Rochester, Minn.
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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EA5163, A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis
Rochester, Minn.,
Jacksonville, Fla.
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 tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer.
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Insomnia in patients with metastatic non small cell lung cancer.
Rochester, Minn.
The purpose of this study is to evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer.
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MC1923 Phase II Clinical Trial of Durvalumab (MEDI4736) and Lurbinectedin in Patients with Relapsed Extensive Stage Small Cell Lung Cancer Previously Treated with Chemotherapy and Immunotherapy
Rochester, Minn.
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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Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial
Rochester, Minn.
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.
Contact Us for the Latest Status
Closed for Enrollment
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(ECTx) A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients with Advanced Solid Tumors Harboring KRAS G12C Mutation
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary objectives of this study are to evaluate the overall safety and tolerability of JAB-21822 monotherapy, and to determine the maximum tolerated dose (MTD) and a recommended Phase II dose (RP2D) of JAB-21822 and in combination with cetuximab administered by prescription (QD) in participants with relapsed or refractory solid tumors with KRAS G12C mutation.
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(ECTx) DS1062-A-U102, Phase 1b, Multicenter, Open-label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Pembrolizumab with or without Platinum Chemotherapy in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung02) (TROPION-Lung02)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This study will assess safety and treatment activity of DS-1062a in combination with pembrolizumab in participants with advanced or metastatic NSCLC without actionable genomic alterations who have had previously treated with platinum-based therapy with or without prior immunotherapy.
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(ECTX) JAB-3312-1003 / A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients with Advanced Solid Tumors
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
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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A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to test the safety and tolerability of HFB200301 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable dose of HFB200301 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
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A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-small Cell Lung Cancer (Adenocarcinoma)
Rochester, Minn.
This randomized pilot clinical trial studies the side effects and best dose of naloxegol and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Naloxegol may relieve some of the side effects of opioid pain medication and fight off future growth in the cancer.
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Comparative Effectiveness of Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Advanced Lung Cancer (REACH PC)
Rochester, Minn.
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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DS1062-A-U202 Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer with Actionable Genomic Alterations and Progressed On or After Kinase Inhibitor Therapy and Platinum- based Chemotherapy (TROPION-Lung05)
(Phase 2 Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer with Actionable Genomic Alterations) (DS1062-A-U202)
Rochester, Minn.,
Jacksonville, Fla.
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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EA5163, A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis
La Crosse, Wis.,
Mankato, Minn.,
Albert Lea, Minn.,
Eau Claire, Wis.
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 tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer.
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First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors.
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Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab
Mankato, Minn.,
Rochester, Minn.,
La Crosse, Wis.,
Eau Claire, Wis.,
Albert Lea, Minn.
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 the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.
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MC1821 - Randomized Phase II Study of Standard Chemotherapy with Docetaxel with or without Bintrafusp Alfa in Patients with Advanced NSCLC after Progressing on a Combination of Anti-PD-1/PD-L1 Agents and Chemotherapy
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
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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NRG-LU003; A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Protocol
Rochester, Minn.
The purpose of this study is to determine whether a combination of biomarker/ALK inhibitors or chemotherapy may work better in treating patients with ALK positive non-squamous non-small cell lung cancer. This National Cancer Institute (NCI)-NRG ALK Protocol phase II trial studies how well a combination of different biomarker/ALK inhibitors work in treating patients with stage IV ALK positive non-squamous non-small cell lung cancer. Lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pemetrexed, 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.
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Phase 1 Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Oraxol (Paclitaxel HM30181A) in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
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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Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Melanoma or Endometrial Carcinoma
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
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 concurrently enroll patients with four distinct advanced malignancies in 5 separate tumor cohorts. The four cancer types are: Non-Small Cell Lung Cancer (NSCLC) and melanoma that are progressing on checkpoint inhibitor (CPI, generally refers to anti-PD(L)1 antibodies) treatment, CPI-naïve hepatocellular carcinoma (HCC), and treatment-naïve endometrioid endometrial cancer.
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PRO-TECT Patient Reported Outcomes to Enhance Cancer Treatment (PRO-TECT)
Mankato, Minn.,
La Crosse, Wis.,
Eau Claire, Wis.
The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.
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The Development of a Shared Decision-Making Encounter Tool for Decisions of Adjuvant Treatment in Patients with Resected Non-Small Cell Lung Cancer (NSCLC)
Rochester, Minn.
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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