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

What Was Tested

This registered phase 2 trial tested Thymosin Alpha-1.

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.

It had two arms (groups): Concurrent Tα-1 group (experimental) and Control group (other).

In control group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation.

The registry classes the interventions as drug and radiation.

Who Took Part

Enrollment: 114 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged ≥18 years old. Histologically confirmed locally advanced and unresectable NSCLC;. No prior radiotherapy or surgery;. With the life expectancy over 12 weeks;. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) clinical study;; with histologically documented combined small-cell lung carcinoma;; major surgery (excluding vascular access placement) within 4 weeks prior to enrollment in the study;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Thymosin Alpha-1 group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Thymosin Alpha-1 study: the participants and staff both knew the treatment.

It started in 2023-07-25 with completion listed for 2026-06-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Completion rate of immunotherapy (time frame: Calculated from the start of treatment to one year after the last treatment completion).

It also tracked 7 secondary outcomes, for example Overall survival, Progression-free survival, Incidence of ≥grade 2 pneumonia, Drop-out rate during the I/O consolidation, The absolute count of total lymphocyte in peripheral blood and The expression of peripheral blood cytokines (including IL2, IL4, IL6, IL10, TNF-α, and IFN-γ).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Thymosin Alpha-1 in 114 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymosin Alpha-1 compound page, all human trials.