NCT05611879

Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC

Efficacy and Safety of Tislelizumab With Platinum Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Initially Unresectable Stage III Non-small Cell Lung Cancer: A Single-arm, Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.

Conditions

• NSCLC, Stage III

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles
DRUG	Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)	Pemetrexed: 500 mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Paclitaxel: 60-75mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles. Nab-paclitaxel: 260mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles.
DRUG	Carboplatin	AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.

Timeline

• Start date: 2023-03-12
• Primary completion: 2024-02-29
• Completion: 2024-04-30
• First posted: 2022-11-10
• Last updated: 2023-12-29

Locations

1 site across 1 country: China