NCT06607926

Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC

Efficacy and Safety of Thymosin α1 Plus Immune Checkpoint Inhibitors and Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage II - IIIB Non Small Cell Lung Cancer: A Prospective, Multicenter, Randomized, Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the efficacy and safety of thymosin α-1 (Tα1) plus chemotherapy and PD-1 inhibitors as neoadjuvant therapy for operable non-small cell lung cancer

Conditions

• Resectable Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Thymosin Alpha 1	4.8 mg subcutaneous injection twice weekly over 12 weeks
DRUG	Tislelizumab	200mg, IV, d1 of each 21-d cycle, four cycles
DRUG	Platinum-doublet chemotherapy	Chemotherapy regimen: (1) for squamous cell carcinoma: cisplatin/carboplatin + paclitaxel; and (2) for non-squamous cell carcinoma: cisplatin/carboplatin + pemetrexed.

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2024-09-23
• Last updated: 2024-09-23

Locations

1 site across 1 country: China