Clinical trial NCT06159790: 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)
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)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Metastatic NSCLC
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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 Criteria:

* 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.

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Best Overall Response (BOR)
timeFrame: up to 9 months from date of randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Sandoz Investigational Site
state: California
city: Los Angeles
country: United States
facility: Sandoz Investigational Site
state: California
city: Orange City
country: United States
facility: Sandoz Investigational Site
state: Florida
city: Silver Spring
country: United States
facility: Sandoz Investigational Site
state: Maryland
city: Renton
country: United States
facility: Sandoz Investigational Site
state: Washington
city: Banja Luka
country: Bosnia and Herzegovina
facility: Sandoz Investigational Site
city: Foca
country: Bosnia and Herzegovina
facility: Sandoz Investigational Site
city: Sarajevo
country: Bosnia and Herzegovina
facility: Sandoz Investigational Site
city: Tuzla
country: Bosnia and Herzegovina
facility: Sandoz Investigational Site
city: Zenica
country: Bosnia and Herzegovina
facility: Sandoz Investigational Site
city: Belo Horizonte
country: Brazil
facility: Sandoz Investigational Site
city: Florianópolis
country: Brazil
facility: Sandoz Investigational Site
city: Fortaleza
country: Brazil
facility: Sandoz Investigational Site
city: Ipatinga
country: Brazil
facility: Sandoz Investigational Site
city: Porto Alegre
country: Brazil
facility: Sandoz Investigational Site
city: Sao Jose Do Rio Preto
country: Brazil
facility: Sandoz Investigational Site
city: Batumi
country: Georgia
facility: Sandoz Investigational Site
city: Tbilisi
country: Georgia
facility: Sandoz Investigational Site
city: Leipzig
country: Germany
facility: Sandoz Investigational Site
city: Rosenheim
country: Germany
facility: Sandoz Investigational Site
city: Wiesbaden
country: Germany
facility: Sandoz Investigational Site
city: Ahmedabad
country: India
facility: Sandoz Investigational Site
city: Bangalore
country: India
facility: Sandoz Investigational Site
city: Bengaluru
country: India
facility: Sandoz Investigational Site
city: Bhubaneswar
country: India
facility: Sandoz Investigational Site
city: Hyderabad
country: India
facility: Sandoz Investigational Site
city: Mumbai
country: India
facility: Sandoz Investigational Site
city: Nagpur
country: India
facility: Sandoz Investigational Site
city: Nashik
country: India
facility: Sandoz Investigational Site
city: New Delhi
country: India
facility: Sandoz Investigational Site
city: Pune
country: India
facility: Sandoz Investigational Site
city: Varanasi
country: India
facility: Sandoz Investigational Site
city: Asahikawa
country: Japan
facility: Sandoz Investigational Site
city: Funabashi
country: Japan
facility: Sandoz Investigational Site
city: Hamamatsu
country: Japan
facility: Sandoz Investigational Site
city: Hiroshima
country: Japan
facility: Sandoz Investigational Site
city: Ibaraki
country: Japan
facility: Sandoz Investigational Site
city: Kanazawa
country: Japan
facility: Sandoz Investigational Site
city: Kumamoto
country: Japan
facility: Sandoz Investigational Site
city: Kyoto
country: Japan
facility: Sandoz Investigational Site
city: Niigata
country: Japan
facility: Sandoz Investigational Site
city: Okayama
country: Japan
facility: Sandoz Investigational Site
city: Sapporo
country: Japan
facility: Sandoz Investigational Site
city: Sumida
country: Japan
facility: Sandoz Investigational Site
city: Yokohama
country: Japan
facility: Sandoz Investigational Site
city: Ōme
country: Japan
facility: Sandoz Investigational Site
city: Ōta
country: Japan
facility: Sandoz Investigational Site
city: Johor Bahru
country: Malaysia
facility: Sandoz Investigational Site
city: Kepala Batas
country: Malaysia
facility: Sandoz Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Sandoz Investigational Site
city: Kuantan
country: Malaysia
facility: Sandoz Investigational Site
city: Kuching
country: Malaysia
facility: Sandoz Investigational Site
city: Melaka
country: Malaysia
facility: Sandoz Investigational Site
city: Petaling Jaya
country: Malaysia
facility: Sandoz Investigational Site
city: Putrajaya
country: Malaysia
facility: Sandoz Investigational Site
city: Bacolod
country: Philippines
facility: Sandoz Investigational Site
city: Cebu City
country: Philippines
facility: Sandoz Investigational Site
city: Makati
country: Philippines
facility: Sandoz Investigational Site
city: Manila
country: Philippines
facility: Sandoz Investigational Site
city: Pasig City
country: Philippines
facility: Sandoz Investigational Site
city: Quezon
country: Philippines
facility: Sandoz Investigational Site
city: Cluj-Napoca
country: Romania
facility: Sandoz Investigational Site
city: Craiova
country: Romania
facility: Sandoz Investigational Site
city: Floresti
country: Romania
facility: Sandoz Investigational Site
city: Iasi
country: Romania
facility: Sandoz Investigational Site
city: Timisoara
country: Romania
facility: Sandoz Investigational Site
city: Belgrade
country: Serbia
facility: Sandoz Investigational Site
city: Kragujevac
country: Serbia
facility: Sandoz Investigational Site
city: A Coruña
country: Spain
facility: Sandoz Investigational Site
city: Barcelona
country: Spain
facility: Sandoz Investigational Site
city: Córdoba
country: Spain
facility: Sandoz Investigational Site
city: Madrid
country: Spain
facility: Sandoz Investigational Site
city: Málaga
country: Spain
facility: Sandoz Investigational Site
city: Oviedo
country: Spain
facility: Sandoz Investigational Site
city: Valencia
country: Spain
facility: Sandoz Investigational Site
city: Douliu
country: Taiwan
facility: Sandoz Investigational Site
city: Kaohsiung
country: Taiwan
facility: Sandoz Investigational Site
city: Taichung City
country: Taiwan
facility: Sandoz Investigational Site
city: Taipei City
country: Taiwan
facility: Sandoz Investigational Site
city: Bangkok
country: Thailand
facility: Sandoz Investigational Site
city: Khon Kaen
country: Thailand
facility: Sandoz Investigational Site
city: Phitsanulok
country: Thailand
facility: Sandoz Investigational Site
city: Adana
country: Turkey
facility: Sandoz Investigational Site
city: Ankara
country: Turkey
facility: Sandoz Investigational Site
city: Bursa
country: Turkey
facility: Sandoz Investigational Site
city: Gaziantep
country: Turkey
facility: Sandoz Investigational Site
city: Istanbul
country: Turkey
facility: Sandoz Investigational Site
city: Izmir
country: Turkey
facility: Sandoz Investigational Site
city: Malatya
country: Turkey
facility: Sandoz Investigational Site
city: Sakarya
country: Turkey
facility: Sandoz Investigational Site
city: Yüreğir
country: Turkey
facility: Sandoz Investigational Site
city: Hanoi
country: Vietnam
facility: Sandoz Investigational Site
city: Ho Chi Minh City
country: Vietnam
facility: Sandoz Investigational Site
city: Ho Chi Minh
country: Vietnam
facility: Sandoz Investigational Site
city: Hà Nội
country: Vietnam
facility: Sandoz Investigational Site
Study officials:
References: