Clinical Trial

JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC）

Active, Not Recruiting Phase 3
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Record status
This record was last updated August 28, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-16; most recent amendment 2025-08-22.
Status change: Recruiting → Active, Not Recruiting 2025-08-22
Trial Details
NCT Number NCT06505837
Lead Sponsor Shanghai Junshi Bioscience Co., Ltd.
Collaborators: Sponsor GmbH
Conditions Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer
Enrollment 395 participants
Start Date 2024-07-11
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-28