Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein
Phase 3, Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Combined With Osimertinib vs Platinum-Based Chemotherapy in Subjects With c-Met Overexpressing (OE) EGFR Mutant, Locally Advanced/Metastatic Non-Squamous NSCLC After a First Progression on Prior Third Generation EGFR TKi Treatment
Sponsor: AbbVie
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
PFS in the Population of Participants with no Central Nervous System (CNS) Metastases at Baseline
Time frame: Up to Approximately 41 Months
Secondary Endpoints
PFS in the Overall Population
Overall Response (OR) in the Population of Participants with no CNS Metastases at Baseline
OR in the Overall Population
Eligibility Criteria
Inclusion Criteria: * Must have metastatic/locally advanced non-squamous NSCLC with documented epidermal growth factor receptor (EGFR) mutation del19 or L858R, with or without T790M mutation, and no identified EGFR mutations known to confer resistance to osimertinib (for instance C797S). * Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. * Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * Must have measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1. * Must have received one prior regimen in the metastatic setting, consisting of a third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKi) (for instance, osimertinib). Participant must have had one disease progression while on this third generation EGFR TKi. Prior-rechallenge with a third generation EGFR TKi is not allowed. Treatment with a fir…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →