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An Open-label Multi-Cohort Phase 1b/2 Study To Evaluate The Safety, Efficacy, And Optimal Dose Of Telisotuzumab Adizutecan In Combination With A PD-1 Immune Checkpoint Inhibitor In Advanced Or Metastatic Non-Squamous NSCLC With No Prior Treatment For Advanced Disease And No Actionable Genomic Alterations (AndroMETa-Lung-536)
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) inhibitor (budigalimab) to adult participants to treat NSCLC.
ABBV-400 and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of ABBV-400 in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 4 treatment groups. Two groups will receive budigalimab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed. One group will receive the standard of care (SOC) pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 172 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with budigalimab or receive IV budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed, or IV SOC pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
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Tumor Molecular Analysis
Jacksonville, FL
The purpose of this study is to develop preclinical models that include cell lines and patient derived xenografts (PDX) that include molecular characterization and testing novel therapies in these preclinical models. Molecular characterization may include short tandem DNA repeat; STR) and oncogenic/tumor suppressor gene mutation analyses to assure that the derived models have not been cross contaminated during the development process with other ongoing lines. Tissue microarray and immunohistochemical (IHC) analysis will also be performed on cell lines, PDX and patient tissues to identify potential molecular targets for therapy.
For patients who consented, patient clinical therapy response data may be correlated with preclinical response data in cell lines and PDX models.
Closed for Enrollment
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A Phase Ib/II, Open-Label, Multicenter Trial with Oral cMET Inhibitor INC280 Alone and in Combination with Erlotinib versus Platinum with Pemetrexed in Adult Patients with EGFR Mutated, cMET-Amplified, Locally Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) with Acquired Resistance to Prior EGFR Tyrosine Kinase Inhibitor (EGFR TKI)
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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Prognostic Significance of CD4+ Helper T Cell Immune Profiles in Patients with Non-Small Cell Lung Cancer
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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Tumor Molecular Analysis
Scottsdale/Phoenix, AZ
Rochester, MN
The purpose of this study is to develop preclinical models that include cell lines and patient derived xenografts (PDX) that include molecular characterization and testing novel therapies in these preclinical models. Molecular characterization may include short tandem DNA repeat; STR) and oncogenic/tumor suppressor gene mutation analyses to assure that the derived models have not been cross contaminated during the development process with other ongoing lines. Tissue microarray and immunohistochemical (IHC) analysis will also be performed on cell lines, PDX and patient tissues to identify potential molecular targets for therapy.
For patients who consented, patient clinical therapy response data may be correlated with preclinical response data in cell lines and PDX models.
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