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Clinical trial

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)

ID
Name
CGME751A12301
Description
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.
Trial arms
Trial start
2024-04-26
Estimated PCD
2026-08-28
Trial end
2026-08-28
Status
Not yet recruiting
Phase
Early phase I
Treatment
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)
Arms:
GME751 + pemetrexed + carboplatin or cisplatin
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)
Arms:
Keytruda-EU + pemetrexed + carboplatin or cisplatin
Size
720
Primary endpoint
Best Overall Response (BOR)
up to 9 months from date of randomization
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 720, 'type': 'ESTIMATED'}}
Updated at
2024-03-27

1 organization

2 products

1 indication

Organization
Sandoz
Product
GME751
Indication
Metastatic Non-Small Cell Lung Cancer
Product
Keytruda