Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
Trial Parameters
Brief Summary
This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated NECTIN4-amplified advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior line of systemic therapy in the advanced/metastatic setting (see inclusion criteria below). The study will comprise of 2 cohorts: Cohort A (non-squamous NSCLC) and Cohort B (squamous NSCLC).
Eligibility Criteria
Key Inclusion Criteria * Histologically or cytologically confirmed advanced or metastatic NSCLC. 1. Cohort A: Histologically or cytologically confirmed non-squamous NSCLC. 2. Cohort B: Histologically or cytologically confirmed squamous NSCLC. * Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay. * Participants must have received at least 1 prior line of systemic therapy in the advanced/metastatic setting. * Participants with no known actionable genomic alterations must have received both platinum based therapy and immunotherapy given either sequentially or in combination for advanced/metastatic NSCLC. Must not have received more than 3 prior lines of systemic therapy in the advanced/metastatic setting. * Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy in the advanced/metastatic setting. *