Immuno-effect of Tα1 for Stage I NSCLC

What Was Tested

The trial (not phased) is built around Thymosin Alpha-1.

To explore the effect of thymosin alpha 1 (Tα1) on postoperative peripheral blood circulating tumor cells and immunosenescence in patients with early-stage non-small cell lung cancer (NSCLC).

It had two arms (groups): Control group (no intervention) and Tα1 group (experimental).

Only observation after surgery.

Tα1 treatment for 3 months after surgery.

The registry classes the interventions as drug.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Pathologically confirmed stage I (per AJCC 8th edition) invasive NSCLC. Undergoing lobectomy and systemic lymph node dessection. Without a previous history of malignant tumors or other concurrent malignancies. Naïve to any anticancer therapies or other immunostimulatory agents. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1, with cardiac, pulmonary, hepatic, cerebral, and renal functions capable of withstanding surgery.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: with a pathologically confirmed non-invasive nsclc, including preinvasive lesions, small cell lung cancer, and benign lesions; post-diagnostic use of immunosuppressive medications or other immunostimulatory agents; with known or suspected active autoimmune disease.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Thymosin Alpha-1 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2024-06-30 with completion listed for 2025-09-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of CTCs (time frame: 4 months after sugery).

It also tracked 3 secondary outcomes, for example Number of immune cells, Peripheral blood immune cells profile and AE.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Thymosin Alpha-1 in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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