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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

February 9, 2023

Primary Completion Date

September 18, 2025

Study Completion Date

November 17, 2025

Conditions
Advanced Lung Cancer
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

Trial Locations (1)

200030

Shanghai Chest Hospital, Shanghai

All Listed Sponsors
lead

Shanghai Junshi Bioscience Co., Ltd.

OTHER