Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type

What Was Tested

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

Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type.

It had two arms (groups): Thymalfasin (Thymosin alpha 1, Ta1) (experimental) and SoC (chemotherapy and platinum agent) (active comparator).

Arm B: 70 patients (control group) will receive SoC chemotherapy and cisplatin (or carboplatin) for twelve months.

The registry classes the interventions as drug.

Who Took Part

140 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age 18 years or older. Activating mutations of EGFR diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or metastatic NSCLC, not amenable to curative surgery or radiotherapy. Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) in a lesion not previously irradiated or non-measurable disease (non measurable disease only for Phase I). Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2. Absolute neutrophil count (ANC) \> 1.5 x 109/liter (L) and platelets \> 100 x 109/L.

The full record lists 11 inclusion and 15 exclusion criteria; among the exclusions: prior therapy with thymosin alpha-1; prior chemotherapy for relapsed and/or metastatic nsclc. neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation; prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Thymosin Alpha-1 group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2016-09 with completion listed for 2019-05.

It ran at 8 sites in Italy (8).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to progression free survival (PFS) (time frame: Up to 12 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Thymosin Alpha-1 in 140 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.