Abscopal Effect for Metastatic Small Cell Lung Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Thymosin Alpha-1.

Patients with small cell lung cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study. 1.

To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic small cell lung cancer patients. 2.

It had 1 arm (groups): Radiotherapy and Thymalfasin arm (experimental).

The registry classes the interventions as drug and radiation.

More on the Plan

Eligible are patients with metastatic small cell lung cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least three separate measurable sites of metastatic lesions.

Extent of metastatic disease is recorded both at CT and PET/CT scanning.

Radiation is given during combined therapy to one of the lesions, 35Gy in 10 fractions over a two week interval, conformally to maximally spare normal tissue or organ.

Thymalfasin treatment is given twice a week with an interval of 3-4 days each week.

Who Took Part

It was open to people of any sex aged from 19 years with no upper age limit.

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

Examples of who could join: Patients with histologically confirmed small cell lung cancer which is persistent and metastatic or recurrent and metastatic;. Patients must have at least 3 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter;. Age ≥18 years;. ECOG performance status: 0-1;. Life expectancy ≥ 3 months.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: patients undergoing therapy with other investigational agents; women who are pregnant or breastfeeding;; patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion;.

How the Study Was Run

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

Being open-label, the Thymosin Alpha-1 study did not mask who received what.

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

It started in 2015-09 with completion listed for 2018-12.

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 7-8 weeks after the initiation of treatment (time frame: week 7- week 8).

It also tracked 2 secondary outcomes, for example The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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