Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC

What Was Tested

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

It had two arms (groups): Control group (active comparator) and Experimental group (experimental).

Neoadjuvant therapy with platinum-doublet chemotherapy plus tislelizumab for four cycles, followed by surgery and adjuvant therapy.

Neoadjuvant therapy with platinum-doublet chemotherapy plus tislelizumab and Tα1 for four cycles, followed by surgery and adjuvant therapy.

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 70 years.

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

Examples of who could join: Males and females aged ≥ 18 years and ≤ 70 years. Presence of at least one measurable lesion on imaging as per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Negative for EGFR and ALK driver mutations. With an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 - 1. With a life expectancy \> 6 months.

The full record lists 20 inclusion and 31 exclusion criteria; among the exclusions: positive for egfr and alk driver mutations or unknown; prior multidisciplinary treatment for lung cancer, including but not limited to surgery, radiotherapy, chemotherapy, and/or immunotherapy (e.g., pd-1 or pd-l1 inhibitors and ctla-4 inhibitors); history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.

How the Study Was Run

Design: 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.

The Thymosin Alpha-1 group and the comparison group ran side by side rather than switching.

Everyone knew when Thymosin Alpha-1 was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-10-15 with completion listed for 2025-06-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathologic complete response rate (time frame: at the time of surgey).

It also tracked 3 secondary outcomes, for example major pathological response rate, Rate of R0 resection and Incidence of irAE.

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.