drugset / Trial / NCT04874844
JY025 is a First-line Treatment for EGFR Mutated NSCLC Phase II and III Clinical Trials of Efficacy and Safety
Phase 2/3
Unknown
420 enrolled
Beijing Dongfang Biotech Co., Ltd.
Chinese Academy of Medical Sciences · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The Phase II study is a multi-center, open, dose escalation and dose extension clinical trial. It is planned to enroll 24 patients; the phase III study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. It is planned to enroll 396 patients, including patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations (EGFR 19 exon deletion or 21 exon mutation).
Timeline
- Start
- 2021-07-30
- Primary completion
- 2022-03-30
- Completion
- 2023-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JY025 | Monoclonal antibody | 10 mg/kg | — |
| Subject | JY025 | Monoclonal antibody | 12 mg/kg | — |
| Subject | JY025 | Monoclonal antibody | 16 mg/kg | — |