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: April 8, 2026
Sponsor: Sandoz
Overall Status: Completed

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: 218
Treatment Group(s): 2
Primary Treatment: GME751
Phase: 3
Study Start date:
April 29, 2024
Estimated Completion Date:
March 16, 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

    Banja Luka,
    Bosnia and Herzegovina

    Site Not Available

  • Sandoz Investigational Site

    Banja Luka 3204541,
    Bosnia and Herzegovina

    Site Not Available

  • Sandoz Investigational Site

    Foca,
    Bosnia and Herzegovina

    Site Not Available

  • Sandoz Investigational Site

    Mostar,
    Bosnia and Herzegovina

    Site Not Available

  • Sandoz Investigational Site

    Sarajevo,
    Bosnia and Herzegovina

    Site Not Available

  • Sandoz Investigational Site

    Sarajevo 3191281,
    Bosnia and Herzegovina

    Site Not Available

  • Sandoz Investigational Site

    Tuzla,
    Bosnia and Herzegovina

    Site Not Available

  • Sandoz Investigational Site

    Zenica,
    Bosnia and Herzegovina

    Site Not Available

  • Sandoz Investigational Site

    Zenica 3186573,
    Bosnia and Herzegovina

    Site Not Available

  • Sandoz Investigational Site

    Belo Horizonte,
    Brazil

    Site Not Available

  • Sandoz Investigational Site

    Belo Horizonte 3470127,
    Brazil

    Site Not Available

  • Sandoz Investigational Site

    Florianópolis,
    Brazil

    Site Not Available

  • Sandoz Investigational Site

    Fortaleza,
    Brazil

    Site Not Available

  • Sandoz Investigational Site

    Fortaleza 3399415,
    Brazil

    Site Not Available

  • Sandoz Investigational Site

    Ipatinga,
    Brazil

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  • Sandoz Investigational Site

    Ipatinga 3461144,
    Brazil

    Site Not Available

  • Sandoz Investigational Site

    Porto Alegre,
    Brazil

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  • Sandoz Investigational Site

    Porto Alegre 3452925,
    Brazil

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    Sao Jose Do Rio Preto,
    Brazil

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    São José do Rio Preto,
    Brazil

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  • Sandoz Investigational Site

    São José do Rio Preto 3448639,
    Brazil

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    Batumi,
    Georgia

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    Batumi 615532,
    Georgia

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    Tbilisi,
    Georgia

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    Tbilisi 611717,
    Georgia

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    Leipzig,
    Germany

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    Rosenheim,
    Germany

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    Rosenheim 2844988,
    Germany

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    Wiesbaden,
    Germany

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    Ahmedabad,
    India

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    Ahmedabad,
    India

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    Ahmedabad 1279233,
    India

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    Ahmedabad 1279233,
    India

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    Bangalore,
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    Bengaluru,
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    Bhubaneswar,
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    Bhubaneswar 1275817,
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    Hyderabad,
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    Hyderabad 1269843,
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    Mumbai,
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    Mumbai,
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    Mumbai 1275339,
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    Mumbai 1275339,
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    Nagpur,
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    Nagpur 1262180,
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    Nashik,
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    Nashik 1261731,
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    New Delhi,
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    New Delhi 1261481,
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    Pune,
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    Varanasi,
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    Varanasi 1253405,
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    Asahikawa,
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    Asahikawa 2130629,
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    Funabashi,
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    Funabashi 1863905,
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    Hamamatsu,
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    Hiroshima,
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    Hiroshima 1862415,
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    Kanazawa 1860243,
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    Niigata 1855431,
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    Okayama 1854383,
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    Sapporo 2128295,
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    Johor Bahru,
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    Johor Bahru 1732752,
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    Kepala Batas,
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    Kuala Lumpur,
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    Kuala Lumpur 1735161,
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    Kuantan,
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    Kuantan 1735227,
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    Kuching 1735634,
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    Putrajaya 6697380,
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    Bacolod,
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    Bacolod 1729580,
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    Cebu City,
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    Cebu City 1717512,
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    Makati,
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    Makati 1703414,
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    Manila,
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    Pasig City,
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    Cluj-Napoca,
    Romania

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    Cluj-Napoca 681290,
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    Craiova,
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    Floresti,
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    Floreşti,
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    Floreşti 678063,
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    Iasi,
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    Timisoara,
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    Belgrade,
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    Kragujevac,
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  • Sandoz Investigational Site

    Kragujevac 789128,
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    A Coruña,
    Spain

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    A Coruña 3119841,
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    Barcelona,
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    Córdoba,
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    Córdoba 2519240,
    Spain

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    Madrid,
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    Madrid 3117735,
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    Málaga,
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    Oviedo,
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    Oviedo 3114711,
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    Valencia,
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    Douliu,
    Taiwan

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    Douliu 1665196,
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    Kaohsiung,
    Taiwan

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    Kaohsiung City,
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    Kaohsiung City 1673820,
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    Taichung,
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    Taichung 1668399,
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    Taichung City,
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    Taipei,
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    Taipei 1668341,
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    Taipei City,
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    Bangkok,
    Thailand

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    Bangkok 1609350,
    Thailand

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    Khon Kaen,
    Thailand

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    Khon Kaen 1609776,
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    Phitsanulok,
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    Adana,
    Turkey

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    Ankara,
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    Bursa,
    Turkey

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    Gaziantep,
    Turkey

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    Istanbul,
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    Izmir,
    Turkey

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    Malatya,
    Turkey

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    Sakarya,
    Turkey

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  • Sandoz Investigational Site

    Yüreğir,
    Turkey

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  • Sandoz Investigational Site

    Adana,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Adana 325363,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Bursa,
    Turkey (Türkiye)

    Site Not Available

  • Sandoz Investigational Site

    Bursa 750269,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Gaziantep,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Gaziantep 314830,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Istanbul,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Istanbul 745044,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Malatya,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Malatya 304922,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Sakarya,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Sakarya 302114,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Yüreğir,
    Turkey (Türkiye)

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  • Sandoz Investigational Site

    Yüreğir 323716,
    Turkey (Türkiye)

    Site Not Available

  • Sandoz Investigational Site

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Sandoz Investigational Site

    Los Angeles, California 90017
    United States

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  • Sandoz Investigational Site

    Fountain Valley 5350207, California 5332921 92708
    United States

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    Orange City, Florida 32763
    United States

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    Silver Spring, Maryland 20910
    United States

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    Renton, Washington 98055
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    Hanoi,
    Vietnam

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  • Sandoz Investigational Site

    Hanoi 1581130,
    Vietnam

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    Ho Chi Minh,
    Vietnam

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    Ho Chi Minh City,
    Vietnam

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    Ho Chi Minh City 1566083,
    Vietnam

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    Hà Nội,
    Vietnam

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  • Sandoz Investigational Site

    Hà Nội 8564175,
    Vietnam

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