Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
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 line of 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).
• Histologically or cytologically confirmed advanced or metastatic NSCLC.
∙ Cohort A: Histologically or cytologically confirmed non-squamous NSCLC.
‣ Cohort B: Histologically or cytologically confirmed squamous NSCLC.
• Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay.
• Participants must not have received more than 3 prior lines 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.
⁃ Those with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET) are eligible provided they have received or are not candidates for available standard targeted therapy in the advanced/metastatic setting.
• Measurable disease as defined by RECIST v1.1.
• Adequate archival or fresh tumor tissue comprised of advanced or metastatic NSCLC should be available for submission to central laboratory, if not provided during prescreening.
• Life expectancy ≥ 12 weeks.
• Eastern Cooperative Oncology Group Performance Status of ≤ 1.