NCT04459663

JS001 Combination Therapy in NSCLC Negative Driving Gene After First-line Chemotherapy.

A Single-arm, Single-center, Phase II Clinical Study to Investigate the Efficacy and Safety of JS001 Combined With Axitinib in the Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) With Negative Driving Gene After First-line Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Li Zhang, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open, single-center clinical study to evaluate the efficacy and safety of JS001 combined with Axitinib in the treatment of advanced non-small cell lung cancer without activated EGFR mutation, ALK fusion and ROS fusion after or during first-line chemotherapy. About 50 subjects will be included in this study and will be treated with JS001 combined with acitinib. Each cycle is 21 days.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab injection combine with Axitinib	The patients in the group will be infused intravenously with fixed dose of 240mg JS001 on the first day of each cycle. Oral Axitinib 5mg bid (recommended interval of about 12 hours) was given daily from the second day of the initial cycle

Timeline

• Start date: 2020-08-31
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2020-07-07
• Last updated: 2020-07-07

Locations

1 site across 1 country: China