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)
NCT ID: NCT06159790
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
218 participants
INTERVENTIONAL
2024-04-29
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GME751 + pemetrexed + carboplatin or cisplatin
Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.
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)
Keytruda-EU + pemetrexed + carboplatin or cisplatin
Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Responsible Party
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Locations
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Sandoz Investigational Site
Fountain Valley, California, United States
Sandoz Investigational Site
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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Bhubaneswar, , India
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Hyderabad, , 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)
Sandoz Investigational Site
Yüreğir, , Turkey (Türkiye)
Sandoz Investigational Site
Hanoi, , Vietnam
Sandoz Investigational Site
Hà Nội, , Vietnam
Sandoz Investigational Site
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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CGME751A12301
Identifier Type: -
Identifier Source: org_study_id