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)

Completed · Phase 3

Conditions studied: Metastatic NSCLC

In brief

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.

Key facts

Study ID

NCT06159790

Run by

Sandoz

People needed

218

Starts

2024-04-29

Expected to finish

2026-03-16

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sandoz Investigational Site — Banja Luka, Bosnia and Herzegovina
• Sandoz Investigational Site — Sarajevo, Bosnia and Herzegovina
• Sandoz Investigational Site — Zenica, Bosnia and Herzegovina
• Sandoz Investigational Site — Belo Horizonte, Brazil
• Sandoz Investigational Site — Fortaleza, Brazil
• Sandoz Investigational Site — Ipatinga, Brazil
• Sandoz Investigational Site — Porto Alegre, Brazil
• Sandoz Investigational Site — São José do Rio Preto, Brazil
• Sandoz Investigational Site — Batumi, Georgia
• Sandoz Investigational Site — Tbilisi, Georgia
• Sandoz Investigational Site — Rosenheim, Germany
• Sandoz Investigational Site 2 — Ahmedabad, India
• Sandoz Investigational Site — Ahmedabad, India
• Sandoz Investigational Site — Bhubaneswar, India
• Sandoz Investigational Site — Hyderabad, India
• Sandoz Investigational Site 2 — Mumbai, India
• Sandoz Investigational Site — Mumbai, India
• Sandoz Investigational Site — Nagpur, India
• Sandoz Investigational Site — Nashik, India
• Sandoz Investigational Site — New Delhi, India
• Sandoz Investigational Site — Varanasi, India
• Sandoz Investigational Site — Asahikawa, Japan
• Sandoz Investigational Site — Funabashi, Japan
• Sandoz Investigational Site — Hiroshima, Japan
• Sandoz Investigational Site — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.