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)

April 8, 2026 updated by: Sandoz

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 duration for a participant will be approximately 56 weeks including screening.

Treatment duration is 52 weeks (17 treatment cycles of study treatment GME751 or Keytruda-EU in combination with chemotherapy, each cycle with a duration of 3 weeks).

Participants will discontinue study participation in case of disease progression, unacceptable toxicity or other reasons.

Participants who are benefiting from treatment with pembrolizumab without signs of progression or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina
        • Sandoz Investigational Site
      • Sarajevo, Bosnia and Herzegovina
        • Sandoz Investigational Site
      • Zenica, Bosnia and Herzegovina
        • Sandoz Investigational Site
  • Brazil
      • 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
  • Georgia
      • Batumi, Georgia
        • Sandoz Investigational Site
      • Tbilisi, Georgia
        • Sandoz Investigational Site
  • Germany
      • Rosenheim, Germany
        • Sandoz Investigational Site
  • India
      • Ahmedabad, India
        • Sandoz Investigational Site
      • Ahmedabad, India
        • Sandoz Investigational Site 2
      • Bhubaneswar, India
        • Sandoz Investigational Site
      • Hyderabad, India
        • Sandoz Investigational Site
      • Mumbai, India
        • Sandoz Investigational Site
      • Mumbai, India
        • Sandoz Investigational Site 2
      • Nagpur, India
        • Sandoz Investigational Site
      • Nashik, India
        • Sandoz Investigational Site
      • New Delhi, India
        • Sandoz Investigational Site
      • Varanasi, India
        • Sandoz Investigational Site
  • Japan
      • Asahikawa, Japan
        • Sandoz Investigational Site
      • Funabashi, Japan
        • Sandoz Investigational Site
      • Hiroshima, Japan
        • Sandoz Investigational Site
      • Kanazawa, Japan
        • Sandoz Investigational Site
      • Niigata, Japan
        • Sandoz Investigational Site
      • Okayama, Japan
        • Sandoz Investigational Site
      • Sapporo, Japan
        • Sandoz Investigational Site
  • Malaysia
      • Johor Bahru, Malaysia
        • Sandoz Investigational Site
      • Kuala Lumpur, Malaysia
        • Sandoz Investigational Site
      • Kuantan, Malaysia
        • Sandoz Investigational Site
      • Kuching, Malaysia
        • Sandoz Investigational Site
      • Malacca, Malaysia
        • Sandoz Investigational Site
      • Petaling Jaya, Malaysia
        • Sandoz Investigational Site
      • Putrajaya, Malaysia
        • Sandoz Investigational Site
  • Philippines
      • Bacolod, Philippines
        • Sandoz Investigational Site
      • Cebu City, Philippines
        • Sandoz Investigational Site
      • Makati, Philippines
        • Sandoz Investigational Site
  • Romania
      • Cluj-Napoca, Romania
        • Sandoz Investigational Site
      • Floreşti, Romania
        • Sandoz Investigational Site
  • Serbia
      • Kragujevac, Serbia
        • Sandoz Investigational Site
  • Spain
      • A Coruña, Spain
        • Sandoz Investigational Site
      • Córdoba, Spain
        • Sandoz Investigational Site
      • Madrid, Spain
        • Sandoz Investigational Site
      • Oviedo, Spain
        • Sandoz Investigational Site
  • Taiwan
      • Douliu, Taiwan
        • Sandoz Investigational Site
      • Kaohsiung City, Taiwan
        • Sandoz Investigational Site
      • Taichung, Taiwan
        • Sandoz Investigational Site
      • Taipei, Taiwan
        • Sandoz Investigational Site
  • Thailand
      • Bangkok, Thailand
        • Sandoz Investigational Site
      • Khon Kaen, Thailand
        • Sandoz Investigational Site
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye)
        • Sandoz Investigational Site
      • Bursa, Turkey (Türkiye)
        • Sandoz Investigational Site
      • Gaziantep, Turkey (Türkiye)
        • Sandoz Investigational Site
      • Istanbul, Turkey (Türkiye)
        • Sandoz Investigational Site
      • Malatya, Turkey (Türkiye)
        • Sandoz Investigational Site
      • Sakarya, Turkey (Türkiye)
        • Sandoz Investigational Site
      • Yüreğir, Turkey (Türkiye)
        • Sandoz Investigational Site
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Sandoz Investigational Site
  • Vietnam
      • Hanoi, Vietnam
        • Sandoz Investigational Site
      • Ho Chi Minh City, Vietnam
        • Sandoz Investigational Site
      • Hà Nội, Vietnam
        • Sandoz Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GME751 + pemetrexed + carboplatin or cisplatin
Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.
Drug: GME751
Drug: GME751 Concentrate for solution for infusion, Biologic, Liquid in vial, 100 mg, 200 mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion)
Active Comparator: Keytruda-EU + pemetrexed + carboplatin or cisplatin
Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.
Drug: Keytruda-EU
Drug: Keytruda-EU Concentrate for solution for infusion, biologic, liquid in vial, 100 mg, 200mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response (BOR)
Time Frame: up to 9 months from date of randomization
Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) up to 9 months according to RECIST 1.1 as assessed by Blinded Central Imaging
up to 9 months from date of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Actual)

March 16, 2026

Study Completion (Actual)

March 16, 2026

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGME751A12301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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