drugset / Trial / NCT06505837
JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC）
Phase 3
Active not recruiting
395 enrolled
Shanghai Junshi Bioscience Co., Ltd.
Sponsor GmbH · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, open-Lable, randomized, phase III clinical study to compare the pharmacokinetic profile, efficacy, and safety of Toripalimab injection (subcutaneous) (JS001sc) and Toripalimab injection (JS001) in combination with standard chemotherapy as first-line treatment for recurrent or metastatic Non-Squamous Non small cell lung cancer
Timeline
- Start
- 2024-07-11
- Primary completion
- 2026-06-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Subcutaneous |
| Subject | Toripalimab | Monoclonal antibody | 360 mg | Subcutaneous |
| Background | Pemetrexed | Small molecule | — | — |