NCT06933329

Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: BicycleTx Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Zelenectide pevedotin	Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.

Timeline

• Start date: 2025-07-18
• Primary completion: 2028-08-31
• Completion: 2029-02-28
• First posted: 2025-04-18
• Last updated: 2026-04-15

Locations

3 sites across 2 countries: France, Spain

Regulatory

• FDA-regulated drug study