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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
Institut Curie
Paris, France
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) assessed by Investigator
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
Time frame: Up to approximately 3 years
Number of participants reporting adverse events (AEs) and abnormalities in laboratory, electrocardiogram (ECG) and vital signs
Safety will be reported as incidence, severity, seriousness, relationship to study treatment, and types of adverse events using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 criteria.
Time frame: Up to approximately 3 years
Duration of Response (DOR) per RECIST v1.1 assessed by the Investigator
DoR as measured by the time from first documentation of disease progression per RECIST v1.1 or to death (due to any cause), whichever occurs first.
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST v1.1 assessed by the Investigator
Percentage of participants with confirmed CR, PR, or stable disease (SD)
Time frame: Up to approximately 3 years
Clinical Benefit Rate (CBR) per RECIST v1.1 assessed by the Investigator
Percentage of participants with CR, PR or SD ≥16 weeks
Time frame: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 assessed by the Investigator
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.
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Time frame: Up to approximately 3 years
Overall Survival (OS)
OS is defined as length of time from the first day of study drug administration (Day 1) to death (due to any cause).
Time frame: Up to approximately 3 years
Time to Progression (TTP) per RECIST v1.1 assessed by the Investigator
TTP is defined as the time from first dose of study drug administration until first documentation of disease progression
Time frame: Up to approximately 3 years