Phase 2 Trial Comparing Imzokitug with Pumitamig and Chemotherapy Versus Pumitamig and Chemotherapy Alone First-Line Treatment for Advanced or Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of combining Imzokitug with Pumitamig and Platinum-Doublet Chemotherapy PDCT compared to Pumitamig and PDCT alone. The study focuses on adults with locally advanced or metastatic non-small cell lung cancer NSCLC who have not received previous systemic therapy for advanced or metastatic disease. This is a Phase 2 interventional trial assessing first-line treatments for this condition. Participants will receive either the combination of Imzokitug, Pumitamig, and PDCT or Pumitamig with PDCT alone. Treatment involves specified doses given on certain days, with tumor tissue samples required for analysis. The study is randomized and parallel in design, with multiple experimental arms. The primary treatment period extends up to approximately four years, during which the response to therapy will be closely monitored. Throughout the trial, participants will undergo evaluations including tumor assessments using RECIST v1.1 criteria to measure objective response rates. Safety will be monitored by documenting adverse events, serious adverse events, and treatment-related effects up to 90 days after the last treatment. Researchers will also track progression-free survival, overall survival, duration of response, and time to recurrence during the study and follow-up periods. The trial is sponsored by Bristol-Myers Squibb and aims to collect comprehensive data over several years.

A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)