drugset / 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)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2024-04-29
- Primary completion
- 2026-03-16
- Completion
- 2026-03-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GME751 | Protein / enzyme biologic | 100 mg | Intravenous |
| Subject | GME751 | Protein / enzyme biologic | 200 mg | Intravenous |
| Comparator | Keytruda-EU | Protein / enzyme biologic | 100 mg | Intravenous |
| Comparator | Keytruda-EU | Protein / enzyme biologic | 200 mg | Intravenous |