NCT05664971

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

A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab and With Standard Chemotherapy in Patients With Advanced Lung Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Advanced Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-09
• Primary completion: 2025-10-23
• Completion: 2025-10-23
• First posted: 2022-12-27
• Last updated: 2025-12-02

Locations

1 site across 1 country: China