Clinical trial · Interventional
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)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GME751 | Drug | Pembrolizumab | ALIAS |
| Keytruda-EU | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GME751 + pemetrexed + carboplatin or cisplatin
- description
- Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.
- interventionNames
- Drug: GME751
- type
- ACTIVE_COMPARATOR
- label
- Keytruda-EU + pemetrexed + carboplatin or cisplatin
- description
- Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion.
- interventionNames
- Drug: Keytruda-EU
Primary outcomes (1)
- measure
- Best Overall Response (BOR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available