Efficacy of Thymosin α1 in Management of Radiation Pneumonitis in Patients With Locally Advanced Non-Small Cell Lung Cancer Treated With Concurrent Chemoradiotherapy: A Phase 2 Clinical Trial (GASTO-1043)

What Was Tested

This clinical trial, phase ii paper looks at Thymosin Alpha-1.

Who Took Part

This phase 2, single-arm trial enrolled patients with unresectable LANSCLC of 18 to 75 years' old and an Eastern Cooperative Oncology Group performance status of 0 to 1.

Eligible patients received definitive CCRT and weekly thymosin α1 from the start of CCRT until 2 months after CCRT.

How the Study Was Run

Patients were administered 51 Gy in 17 daily fractions or 40 Gy in 10 daily fractions in the first course followed by a re-evaluation and those patients without disease progression had an adaptive plan of 15 Gy in 5 daily fractions or 24 Gy in 6 daily fractions as a boost.

The primary endpoint was the incidence of Grade (G) ≥2 RP.

Secondary endpoints included the incidence of late pulmonary fibrosis, total lymphocyte count (TLC), serum C-reactive protein (CRP) levels, and the composition of gut microbiota.

TLC and CRP data were collected at baseline, 2 to 3 weeks during CCRT, the end of CCRT, 2 and 6 months after CCRT.

Fecal samples were collected at baseline and the end of CCRT.

What Was Measured

Patients treated with CCRT but without thymosin α1 intervention during the same period were selected as the control group by the propensity score matching method.

The subject headings attached to it are Antineoplastic Combined Chemotherapy Protocols, C-Reactive Protein, Carcinoma, Non-Small-Cell Lung, Chemoradiotherapy, Docetaxel, Lung Neoplasms and Lymphopenia.

What This Means in Plain Language

This is a clinical trial, phase ii of Thymosin Alpha-1.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2022 (International journal of radiation oncology, biology, physics), a journal based in United States.

More context: the Thymosin Alpha-1 compound page.