First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation Positive Non Small Cell Lung Cancer Who Are Taking Standard of Care Therapy

What Was Tested

The trial (phase 1, phase 2) is built around Thymosin Alpha-1.

It had three arms (groups): Thymalfasin biw plus SoC (tyrosine kinase inhibitor) (experimental), Thymalfasin plus SoC (tyrosine kinase inhibitor) (experimental) and SoC (tyrosine kinase inhibitor) (active comparator).

Twice weekly thymalfasin.

5 times a week thymalfasin.

12 months.

The registry classes the interventions as drug.

More on the Plan

The study will be conducted in subjects with sensitizing EGFR mutation positive Non Small Cell Lung Cancer.

Subjects with sensitizing EGFR mutation positive NSCLC will be screened for eligibility by the clinical center involved.

The study will be conducted in two parts.

In Phase II patients will be randomized to SoC or Thymosin alpha 1 plus SoC for treatment duration of 12 months.

Who Took Part

188 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 EGFRdiagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or metastaticNSCLC, 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.

Nothing was hidden in this open-label Thymosin Alpha-1 study: the participants and staff both knew the treatment.

It started in 2016-10 with completion listed for 2019-12.

It ran at 5 sites in Italy (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of treatment-related adverse events (time frame: Up to 4 months). PFS (time frame: Up to12 months).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Thymosin Alpha-1 in 188 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.