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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

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Overview Studies Clinical Trials

Active Not Recruiting PHASE2 INTERVENTIONAL NCT06139419

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Detailed Description

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. Patients with locally advanced NSCLC who will receive concurrent radiochemotherapy followed by immunotherapy consolidation will be randomly divided into two groups (concurrent Tα1 treatment group and control group \[in which Tα1 will not be used\]), and the overall survivals, progression-free survivals (PFS), completion rate of immunotherapy consolidation, toxicities/adverse effects, and peripheral blood immune biomarkers will be compared between these two groups.

Interventions

Name: definitive radiotherapy

Type: RADIATION

Description: Participants were treated with definitive thoracic radiotherapy

Name: induction chemo-immunotherapy

Type: DRUG

Description: 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.

Name: concurrent chemotherapy

Type: DRUG

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

Name: Immunotheapy consolidation

Type: DRUG

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

Name: Thymosin Alpha1

Type: DRUG

Description: 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.

Primary Outcomes

Measure: Completion rate of immunotherapy

TimeFrame: Calculated from the start of treatment to one year after the last treatment completion

Description: Proportion of participants completing 12 months of consolidation of immutherapy

Trial Information

NCT ID

NCT06139419

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Sun Yat-sen University

Last Updated

December 15, 2025