NCT06159790CompletedPhase 3
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)
A Randomized, Double-blind, Parallel-group Study to Compare Efficacy, Safety, and Immunogenicity of GME751 (Proposed Pembrolizumab Biosimilar) and EU-authorized Keytruda® in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (actual)
- First submitted
- 10 Oct 2023
- Start date
- Apr 2024
- Primary completion date
- Mar 2026
- Lead sponsor
- Sandoz
- Diseases
- Lung cancer
- NCT number
- NCT06159790
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 218
- From Apr 2024 to the primary completion date, Mar 2026
- 62 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Squamous cell or mixed histology in NSCLC
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.