NCT03623776

Neoadjuvant JS001, or JS001 in Combination With Pemetrexed and Carboplatin in Resectable NSCLC.

A Multicenter Phase II Trial of Neoadjuvant JS001, or JS001 in Combination With Chemotherapy in Resectable NSCLC.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2. The purpose of this study is to studying neoadjuvant JS001, or JS001 in combination with pemetrexed and carboplatin to see how well it works in treating patients with resectable NSCLC.

Detailed description

Surgery in combination with preoperative or postoperative chemotherapy is the recommended therapeutic approach for patients with resectable non-small cell lung cancer (NSCLC). However, the prognosis of early-stage NSCLC remains to be improved, with 5-year survival rates ranging from 50% for stage IA to 20% for stage IIIA. Antibodies that block the PD-1 protein have provided a major treatment advance in patients with cancer. JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which has shown its efficacy in the treatment of a variety of malignancies. This study is to studying neoadjuvant JS001, or JS001 in combination with chemotherapy to see how well it works in treating patients with resectable NSCLC.

Conditions

• Efficacy and Safety

Interventions

Type	Name	Description
DRUG	JS001	JS001 was given 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.
DRUG	Pemetrexed	Subjects receive pemetrexed of 500 mg/m\^2 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
DRUG	Carboplatin	Subjects receive carboplatin at the AUC of 5 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
PROCEDURE	Thoracic Surgery	Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.

Timeline

• Start date: 2019-02-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2018-08-09
• Last updated: 2024-12-06

Locations

1 site across 1 country: China