Status:
SUSPENDED
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)
Lead Sponsor:
Sandoz
Conditions:
Metastatic NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (irr...
Detailed Description
Eligible participants will be randomized in a 1:1 ratio to receive either GME751, or European Union (EU)-authorized pembrolizumab (Keytruda-EU) in combination with chemotherapy. The maximum study dura...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT06159790
Start Date
April 29 2024
End Date
February 1 2026
Last Update
December 17 2025
Active Locations (60)
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1
Sandoz Investigational Site
Fountain Valley, California, United States, 92708
2
Sandoz Investigational Site
Banja Luka, Bosnia and Herzegovina
3
Sandoz Investigational Site
Sarajevo, Bosnia and Herzegovina
4
Sandoz Investigational Site
Zenica, Bosnia and Herzegovina