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)
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Sandoz |
| Information Provided By: | Sandoz |
| Last Update Posted: | 2026-04-09 |
Study Overview
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.
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)
Conditions
Metastatic NSCLC
Intervention / Treatment
- Drug: GME751
- Drug: Keytruda-EU
Other Study ID Numbers
- CGME751A12301
Start Date (Actual)
2024-04-29
Primary Completion Date (Actual)
2026-03-16
Study Completion Date (Actual)
2026-03-16
Enrollment (Actual)
218
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Sandoz |
| Information Provided By: | Sandoz |
| Last Update Posted: | 2026-04-09 |
Study Overview
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.
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)
Conditions
Metastatic NSCLC
Intervention / Treatment
- Drug: GME751
- Drug: Keytruda-EU
Other Study ID Numbers
- CGME751A12301
Start Date (Actual)
2024-04-29
Primary Completion Date (Actual)
2026-03-16
Study Completion Date (Actual)
2026-03-16
Enrollment (Actual)
218
Study Type
Interventional
Phase
Phase 3