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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)
Sponsor: Sandoz
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2024-04-29
Completion Date
2026-03-16
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (62)
Sandoz Investigational Site
Fountain Valley, California, United States
Sandoz Investigational Site
Banja Luka, Bosnia and Herzegovina
Sandoz Investigational Site
Sarajevo, Bosnia and Herzegovina
Sandoz Investigational Site
Zenica, Bosnia and Herzegovina
Sandoz Investigational Site
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
Batumi, Georgia
Sandoz Investigational Site
Tbilisi, Georgia
Sandoz Investigational Site
Rosenheim, Germany
Sandoz Investigational Site 2
Ahmedabad, India
Sandoz Investigational Site
Ahmedabad, India
Sandoz Investigational Site
Bhubaneswar, India
Sandoz Investigational Site
Hyderabad, India
Sandoz Investigational Site 2
Mumbai, India
Sandoz Investigational Site
Mumbai, India
Sandoz Investigational Site
Nagpur, India
Sandoz Investigational Site
Nashik, India
Sandoz Investigational Site
New Delhi, India
Sandoz Investigational Site
Varanasi, India
Sandoz Investigational Site
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
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
Bacolod, Philippines
Sandoz Investigational Site
Cebu City, Philippines
Sandoz Investigational Site
Makati, Philippines
Sandoz Investigational Site
Cluj-Napoca, Romania
Sandoz Investigational Site
Floreşti, Romania
Sandoz Investigational Site
Kragujevac, Serbia
Sandoz Investigational Site
A Coruña, Spain
Sandoz Investigational Site
Córdoba, Spain
Sandoz Investigational Site
Madrid, Spain
Sandoz Investigational Site
Oviedo, Spain
Sandoz Investigational Site
Douliu, Taiwan
Sandoz Investigational Site
Kaohsiung City, Taiwan
Sandoz Investigational Site
Taichung, Taiwan
Sandoz Investigational Site
Taipei, Taiwan
Sandoz Investigational Site
Bangkok, Thailand
Sandoz Investigational Site
Khon Kaen, Thailand
Sandoz Investigational Site
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
Hanoi, Vietnam
Sandoz Investigational Site
Hà Nội, Vietnam
Sandoz Investigational Site
Ho Chi Minh City, Vietnam