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)

PHASE3SuspendedINTERVENTIONAL
Enrollment

720

Participants

Timeline

Start Date

April 29, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Metastatic NSCLC
Interventions
DRUG

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)

DRUG

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)

Trial Locations (92)

20910

Sandoz Investigational Site, Silver Spring

32763

Sandoz Investigational Site, Orange City

90017

Sandoz Investigational Site, Los Angeles

92708

Sandoz Investigational Site, Fountain Valley

98055

Sandoz Investigational Site, Renton

Unknown

Sandoz Investigational Site, Banja Luka

Sandoz Investigational Site, Foča

Sandoz Investigational Site, Mostar

Sandoz Investigational Site, Sarajevo

Sandoz Investigational Site, Tuzla

Sandoz Investigational Site, Zenica

Sandoz Investigational Site, Belo Horizonte

Sandoz Investigational Site, Florianópolis

Sandoz Investigational Site, Fortaleza

Sandoz Investigational Site, Ipatinga

Sandoz Investigational Site, Porto Alegre

Sandoz Investigational Site, São José do Rio Preto

Sandoz Investigational Site, Batumi

Sandoz Investigational Site, Tbilisi

Sandoz Investigational Site, Leipzig

Sandoz Investigational Site, Rosenheim

Sandoz Investigational Site, Wiesbaden

Sandoz Investigational Site, Ahmedabad

Sandoz Investigational Site, Bangalore

Sandoz Investigational Site, Bengaluru

Sandoz Investigational Site, Bhubaneswar

Sandoz Investigational Site, Hyderabad

Sandoz Investigational Site, Mumbai

Sandoz Investigational Site, Nagpur

Sandoz Investigational Site, Nashik

Sandoz Investigational Site, New Delhi

Sandoz Investigational Site, Pune

Sandoz Investigational Site, Varanasi

Sandoz Investigational Site, Asahikawa

Sandoz Investigational Site, Funabashi

Sandoz Investigational Site, Hiroshima

Sandoz Investigational Site, Ibaraki

Sandoz Investigational Site, Kanazawa

Sandoz Investigational Site, Kumamoto

Sandoz Investigational Site, Kyoto

Sandoz Investigational Site, Niigata

Sandoz Investigational Site, Okayama

Sandoz Investigational Site, Ōta-ku

Sandoz Investigational Site, Sapporo

Sandoz Investigational Site, Sumida City

Sandoz Investigational Site, Yokohama

Sandoz Investigational Site, Johor Bahru

Sandoz Investigational Site, Kepala Batas

Sandoz Investigational Site, Kuala Lumpur

Sandoz Investigational Site, Kuantan

Sandoz Investigational Site, Kuching

Sandoz Investigational Site, Malacca

Sandoz Investigational Site, Petaling Jaya

Sandoz Investigational Site, Putrajaya

Sandoz Investigational Site, Bacolod

Sandoz Investigational Site, Cebu City

Sandoz Investigational Site, Makati

Sandoz Investigational Site, Manila

Sandoz Investigational Site, Pasig

Sandoz Investigational Site, Quezon

Sandoz Investigational Site, Cluj-Napoca

Sandoz Investigational Site, Floreşti

Sandoz Investigational Site, Iași

Sandoz Investigational Site, Timișoara

Sandoz Investigational Site, Belgrade

Sandoz Investigational Site, Kragujevac

Sandoz Investigational Site, A Coruña

Sandoz Investigational Site, Barcelona

Sandoz Investigational Site, Córdoba

Sandoz Investigational Site, Madrid

Sandoz Investigational Site, Málaga

Sandoz Investigational Site, Oviedo

Sandoz Investigational Site, Valencia

Sandoz Investigational Site, Douliu

Sandoz Investigational Site, Kaohsiung City

Sandoz Investigational Site, Taichung

Sandoz Investigational Site, Taipei

Sandoz Investigational Site, Bangkok

Sandoz Investigational Site, Khon Kaen

Sandoz Investigational Site, Phitsanulok

Sandoz Investigational Site, Adana

Sandoz Investigational Site, Ankara

Sandoz Investigational Site, Bursa

Sandoz Investigational Site, Gaziantep

Sandoz Investigational Site, Istanbul

Sandoz Investigational Site, Izmir

Sandoz Investigational Site, Malatya

Sandoz Investigational Site, Sakarya

Sandoz Investigational Site, Yüreğir

Sandoz Investigational Site, Hanoi

Sandoz Investigational Site, Hà Nội

Sandoz Investigational Site, Ho Chi Minh City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sandoz

INDUSTRY