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ACTIVE NOT RECRUITING
NCT06139419
PHASE2

The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities.

Official title: A Prospective Phase II Controlled Study to Evaluate the Impact of Thymosin Alpha 1 on the Completion Rate of Consolidation Immunotherapy After Radical Radiochemotherapy for Locally Advanced Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2023-07-25

Completion Date

2026-08-30

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

RADIATION

definitive radiotherapy

Participants were treated with definitive thoracic radiotherapy

DRUG

induction chemo-immunotherapy

All participants receive two cycles of albumin-bound paclitaxel (260mg/m2) on d1 and cisplatin (25mg/m2) from d1 to d3 in combination with tislelizumab (200mg) on d1.

DRUG

concurrent chemotherapy

Concurrent chemotherapy consists of weekly albumin-bound paclitaxel (50mg/m2) and cisplatin (25mg/m2).

DRUG

Immunotheapy consolidation

Participants without disease progression, grade ≥3 toxicities, and/or grade ≥2 pneumonitis after CCRT receive tislelizumab 200 mg (Q3W) for up to 12 months.

DRUG

Thymosin Alpha1

Participants in the Tα1 treatment group will receive Tα1 from the beginning of induction chemo-immunotherapy until the completion of immunotherapy consolidation. In detail, Tα-1 would be administered according to the following three stages: 1. Induction chemo-immunotherapy: Tα-1 will be subcutaneously administered at 4.8 mg on d1 and d3 for each cycle. 2. Concurrent chemoradiotherapy: Tα-1 will be subcutaneously administered at 4.8mg biweekly. 3. Immunotherpay consolidation: Tα-1 will be administered concurrently with tislelizumab at 4.8mg (Q3W) for up to 12 months.

Locations (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, China