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

NCT06505837 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2025-08-28

No results posted yet for this study

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

Conditions

  • Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer

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).

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Principal Investigators

  • Weihua Wang, doctorate · Medical director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2026-06-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505837 on ClinicalTrials.gov