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ACTIVE NOT RECRUITING
NCT06505837
PHASE3

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

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

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

Official title: Open-Label, Randomized, Phase III Clinical Study Comparing the Pharmacokinetic Profile, Efficacy, and Safety of JS001sc and JS001 in Combination With Standard Chemotherapy as First-Line Treatment for Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

395

Start Date

2024-07-11

Completion Date

2026-12-30

Last Updated

2025-08-28

Healthy Volunteers

No

Interventions

DRUG

JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy

The combination therapy of JS001sc and pemetrexed/platinum lasted for 4 cycles, after which subjects who did not progress continued to receive JS001sc and pemetrexed maintenance therapy, and the cumulative treatment of JS001sc did not exceed 35 cycles (Each cycle is 21 days).

DRUG

JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy

The combination therapy of JS001 and pemetrexed/platinum lasted for 4 cycles, after which subjects who did not progress continued to receive JS001 and pemetrexed maintenance therapy, and the cumulative treatment of JS001 did not exceed 35 cycles (Each cycle is 21 days).

Locations (1)

Hunan Cancer Hospital

Changshang, Hunan, China