A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Trial end date: 2026-08-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status), without sensitizing EGFR or ALK mutations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• At least 18 years of age

• Untreated metastatic NSCLC

• Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements

• Measurable disease according to RECIST 1.1

• Adequate organ function

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

• Squamous cell or mixed histology in NSCLC

• Known history of hypersensitivity (grade ≥3) to pembrolizumab, chemotherapy or their excipients

• Active autoimmune disease that has required chronic systemic treatment in the past 2 years.

• Received live vaccine ≤30 days before the first study treatment

• Prior treatment with pembrolizumab or any other anti-PD-1, or anti-PD-L1 or anti-PD-L2, or anti-CTLA-4 agent or any antibody targeting other immune-regulatory receptors or mechanisms for lung cancer.

Other protocol-defined inclusion/exclusion criteria apply.