Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy

What Was Tested

This registered phase 2 trial tested Thymosin Alpha-1.

The investigators postulated that the exploitation of the pro-immunogenic effects of radiotherapy with thymosin might result in abscopal responses among patients with metastatic cancer.

An exploratory biomarker analysis in blood and tumor samples is also planned.

It had 1 arm (groups): 1 (experimental).

The registry classes the interventions as drug and radiation.

Who Took Part

46 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: Age 18 years or older. ECOG Performance Status 0-2. For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment. Patients and their family signed the informed consents.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: received chemotherapy before tki therapy; brain parenchyma or leptomeningeal disease; concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment.

How the Study Was Run

Design: single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-05 with completion listed for 2017-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy (time frame: 1-6 months).

It also tracked 3 secondary outcomes, for example To assess the short-term quality of life (QOL), Rate of CTCAE grade 2 or higher radiation pneumonitis and Overall Survival.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Thymosin Alpha-1 in 46 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.