NCT04304248

Neoadjuvant Toripalimab Plus Platinum-based Doublet for Stage III Non-small Cell Lung Cancer

A Phase II Study of Neoadjuvant Toripalimab Plus Platinum-based Doublet for Potentially Resectable Stage III Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hao Long · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, phase II, multi-center clinical trial. Thirty patients will be enrolled in this trial to investigate the pathological complete response rate defined as the absence of residual tumor in lung and lymph nodes treated by chemo-immunotherapy.

Detailed description

This is an open-label, single-arm, phase II, multi-center clinical trial. Eligible patients will receive Toripalimab 240mg + Albumin-bound paclitaxel 260mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days (+/-3 days) as neoadjuvant treatment followed by surgery 3-4 weeks after the last dose of chemo-immunotherapy. The primary objective is major pathologic response (MPR), defined as less than 10% tumor cells in the pathologically resected specimen. Patient accrual is expected to be completed within 18 months excluding a run-in-phase of 3 months. Patients will be followed 3 years after surgery. The study will end once survival follow-up has concluded.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Albumin-bound paclitaxel, Carboplatin, Toripalimab	Eligible patients will receive Toripalimab 240mg + Albumin-bound paclitaxel 260mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days (+/-3 days) as neoadjuvant treatment

Timeline

• Start date: 2019-08-01
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2020-03-11
• Last updated: 2021-05-06

Locations

1 site across 1 country: China