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)
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.
Checked against the public recordLast updated Apr 9, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Sandoz
- Interventions being studied
- Drug: GME751; Drug: Keytruda-EU
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Sandoz Investigational SiteFountain Valley, California
- Sandoz Investigational SiteBanja Luka
- Sandoz Investigational SiteSarajevo
- Sandoz Investigational SiteZenica
- Sandoz Investigational SiteBelo Horizonte
- Sandoz Investigational SiteFortaleza
- Sandoz Investigational SiteIpatinga
- Sandoz Investigational SitePorto Alegre
- Sandoz Investigational SiteSão José do Rio Preto
- Sandoz Investigational SiteBatumi
- Sandoz Investigational SiteTbilisi
- Sandoz Investigational SiteRosenheim
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 9, 2026. Always confirm current availability with the study team.