NCT04865705

Neoadjuvant Chemotherapy and Tilelizumab in Stage III（cTNM-IIIA.IIIB）Non-small-cell Lung Cancer

Neoadjuvant Chemotherapy and Tilelizumab in Stage III（cTNM-IIIA.IIIB）Non-small-cell Lung Cancer ,a Single-arm, Phase Ⅱ Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, one-arm, phase II study aimed at evaluating tislelizumab combined with platinum-containing dual-drug chemotherapy as a neoadjuvant treatment, supplemented with tislelizumab after surgery in patients with stage III non-small cell lung cancer.

Detailed description

The study included a screening period, a treatment period (including neoadjuvant treatment, surgery and postoperative adjuvant treatment), and a survival follow-up period. Patients who meet the admission criteria will receive the following treatments according to disease stage (IIIA/IIIB) and histology (squamous or non-squamous) Tilelizumab + platinum-containing dual-agent chemotherapy, every 3 weeks as a cycle , for 2 cycles, followed by surgical resection, and postoperative adjuvant Tilelizumab + platinum-containing dual-agent chemotherapy 2cycles,every 3 weeks as a cycle, and Tilelizumab every 3 weeks up to 15cycles maintenance treatment. The rate of radical resection (R0) was evaluated through the research center of the investigator, which is expected to be 20% higher compared with historical controls, and the effectiveness of tislelizumab combined with platinum-containing dual-drug chemotherapy as a neoadjuvant treatment was evaluated.

Conditions

• Stage III
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	tislelizumab	Tilelizumab 200mg d1 Q3W Albumin Paclitaxel 260mg/m2 d1 Carboplatin/Cisplatin 75mg/m2/AUC5 d1 every 3 weeks

Timeline

• Start date: 2020-11-10
• Primary completion: 2021-12-10
• Completion: 2022-06-10
• First posted: 2021-04-29
• Last updated: 2021-04-29

Locations

1 site across 1 country: China