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

PHASE2RecruitingINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

July 25, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2026

Conditions
Non-small Cell Lung Cancer
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."

Trial Locations (1)

510000

RECRUITING

Sun yat-sen university cancer center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER