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

Phase 2

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Zelenectide pevedotin (BT8009)

• Registration Number: NCT06933329
• Lead Sponsor: BicycleTx Limited

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 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2028-08-31
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A (non-squamous NSCLC)	Zelenectide pevedotin (BT8009)	-
Cohort B (squamous NSCLC)	Zelenectide pevedotin (BT8009)	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by Investigator	Up to approximately 3 years	Percentage of participants with either a confirmed complete response (CR) or partial response (PR)

Secondary Outcome Measures

Name	Time	Method
Number of participants reporting adverse events (AEs) and abnormalities in laboratory, electrocardiogram (ECG) and vital signs	Up to approximately 3 years	Safety will be reported as incidence of treatment-emergent adverse events using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 criteria.
Duration of Response (DOR) per RECIST v1.1 as assessed by the Investigator	Up to approximately 3 years	DoR as measured by the time from first documentation of objective response to the first documentation of disease progression or to death (due to any cause), whichever occurs first.
Disease Control Rate (DCR) per RECIST v1.1 as assessed by the Investigator	Up to approximately 3 years	Percentage of participants with confirmed CR, PR, or stable disease (SD)
Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the Investigator	Up to approximately 3 years	Percentage of participants with CR, PR or SD ≥16 weeks
Progression Free Survival (PFS) per RECIST v1.1 as assessed by the Investigator	Up to approximately 3 years	PFS is measured by the time from the first day of study drug administration (Day 1) to the first documentation of disease progression, or to death (due to any cause), whichever occurs first.
Overall Survival (OS)	Up to approximately 3 years	OS is defined as length of time from the first day of study drug administration (Day 1) to death (due to any cause).
Time to Progression (TTP) per RECIST v1.1 as assessed by the Investigator	Up to approximately 3 years	TTP is defined as the time from first dose of study drug administration until first documentation of disease progression