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)

Conditions

• Metastatic NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GME751 — DRUG
  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
  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)

Study Details

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.

Key Dates

Start date

Apr 29, 2024

Status verified

Apr 2026

Primary completion

Mar 16, 2026

Completion

Mar 16, 2026

Study Design

Enrollment

218 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: GME751 + pemetrexed + carboplatin or cisplatin
  Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.
• Active Comparator: Keytruda-EU + pemetrexed + carboplatin or cisplatin
  Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.

Primary Outcome Measure

Best Overall Response (BOR) [ Time Frame: up to 9 months from date of randomization ]

Locations (1)

Related coverage on Hipa.ai

• Pembrolizumab Biosimilar Trial for Metastatic NSCLC Completes Primary Phase
  Pembrolizumab · Mar 16, 2026 · ClinicalTrials.gov

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