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CompletedPhase 3NCT06159790
Official study title

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)

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGME751 and Keytruda-EU

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 9, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?62 U.S. locations

Locations may change over time.

Who runs it?Sandoz

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Sandoz
Interventions being studied
Drug: GME751; Drug: Keytruda-EU
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Biomarkers
PD-L1→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

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