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)

NCT06159790 | Completed Phase 3 FDA Drug

• 1 other identifier: CGME751A12301
• Study Type: interventional
• Target: 218
• Locations: 16 countries
• Sites: 62

Brief 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.

Conditions

Metastatic NSCLC

Outcome Measures

Primary Outcomes (1)

• Best Overall Response (BOR)

  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

Study Arms (2)

GME751 + pemetrexed + carboplatin or cisplatin

EXPERIMENTAL

Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.

Drug: GME751

Keytruda-EU + pemetrexed + carboplatin or cisplatin

ACTIVE COMPARATOR

Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.

Drug: Keytruda-EU

Interventions

GME751 DRUG

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)

GME751 + pemetrexed + carboplatin or cisplatin

Keytruda-EU DRUG

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)

Keytruda-EU + pemetrexed + carboplatin or cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (62)

Sandoz Investigational Site

Fountain Valley, California, 92708, United States

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Banja Luka, Bosnia and Herzegovina

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Sarajevo, Bosnia and Herzegovina

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Zenica, Bosnia and Herzegovina

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Belo Horizonte, Brazil

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Fortaleza, Brazil

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Ipatinga, Brazil

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Porto Alegre, Brazil

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São José do Rio Preto, Brazil

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Batumi, Georgia

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Tbilisi, Georgia

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Rosenheim, Germany

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Ahmedabad, India

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Ahmedabad, India

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Bhubaneswar, India

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Hyderabad, India

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Mumbai, India

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Mumbai, India

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Nagpur, India

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Nashik, India

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New Delhi, India

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Varanasi, India

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Asahikawa, Japan

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Funabashi, Japan

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Hiroshima, Japan

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Kanazawa, Japan

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Niigata, Japan

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Okayama, Japan

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Sapporo, Japan

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Johor Bahru, Malaysia

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Kuala Lumpur, Malaysia

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Kuantan, Malaysia

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Kuching, Malaysia

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Malacca, Malaysia

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Petaling Jaya, Malaysia

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Putrajaya, Malaysia

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Bacolod, Philippines

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Cebu City, Philippines

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Makati, Philippines

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Cluj-Napoca, Romania

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Floreşti, Romania

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Kragujevac, Serbia

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A Coruña, Spain

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Córdoba, Spain

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Madrid, Spain

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Oviedo, Spain

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Douliu, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Bangkok, Thailand

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Khon Kaen, Thailand

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Adana, Turkey (Türkiye)

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Bursa, Turkey (Türkiye)

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Gaziantep, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Malatya, Turkey (Türkiye)

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Sakarya, Turkey (Türkiye)

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Yüreğir, Turkey (Türkiye)

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Hanoi, Vietnam

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Hà Nội, Vietnam

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Ho Chi Minh City, Vietnam

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: December 7, 2023
• Study Start: April 29, 2024
• Primary Completion: March 16, 2026
• Study Completion: March 16, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2); MY (7); PH (3); ES (4); BO (3); TH (2); TW (4); VN (3); GE (2); SE (1); US (1); JP (7); TU (7); DE (1); IN (10); BR (5)