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)

Last updated: May 28, 2024
Sponsor: Sandoz
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

GME751

Keytruda-EU

Clinical Study ID

NCT06159790
CGME751A12301
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Squamous cell or mixed histology in NSCLC

  • Known history of hypersensitivity (grade ≥3) to pembrolizumab, chemotherapy or theirexcipients

  • Active autoimmune disease that has required chronic systemic treatment in the past 2years.

  • Received live vaccine ≤30 days before the first study treatment

  • Prior treatment with pembrolizumab or any other anti-PD-1, or anti-PD-L1 oranti-PD-L2, or anti-CTLA-4 agent or any antibody targeting other immune-regulatoryreceptors or mechanisms for lung cancer.

Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 720
Treatment Group(s): 2
Primary Treatment: GME751
Phase: 3
Study Start date:
April 29, 2024
Estimated Completion Date:
August 28, 2026

Study 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.

Connect with a study center

  • Sandoz Investigational Site

    Tbilisi,
    Georgia

    Active - Recruiting

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