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JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer

NCT05664971 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-12-02

No results posted yet for this study

Summary

This is an open-label phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab and with or without standard chemotherapy in patients with advanced lung cancer

Conditions

Interventions

BIOLOGICAL

Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection

200mg via IV infusion once every 3 weeks;JS004 will be administered in combination with toripalimab until disease progression or intolerable toxicity or up to 2 years of treatment or other reasons specified in the protocol

BIOLOGICAL

Toripalimab

240mg via IV infusion once every 3 weeks;JS004 will be administered in combination with toripalimab until disease progression or intolerable toxicity or up to 2 years of treatment or other reasons specified in the protocol

DRUG

Docetaxel

60 or 75mg/m2 via IV infusion on Day 1 of a 21-day cycle, which may be maintained until disease progression

DRUG

Pemetrexed

500mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles; Subjects who have disease progression after 4 cycles may continue to receive maintenance treatment with pemetrexed

DRUG

Cisplatin

75mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles

DRUG

Carboplatin

AUC 5 via IV infusion on Day 1 of a 21-day cycle for 4 cycles

DRUG

Paclitaxel

175mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles

DRUG

Etoposide

100mg/m2 via IV infusion on Days 1, 2, and 3 of a 21-day cycle for 4 cycles

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2025-10-23
Completion
2025-10-23

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT05664971 on ClinicalTrials.gov