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Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer
Plain-language guide to NCT03659578: phase 2 interventional trial of Thymosin Alpha-1, 69 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03659578
- Phase
- phase 2
- Status
- completed
- Start
- 2018-08-09
- Completion (planned or actual)
- 2021-09-30
- Participants
- 69 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Non-small Cell Lung Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Thymosin Alpha-1.
It had 1 arm (groups): Thymosin α1 (experimental).
The registry classes the interventions as drug and radiation.
More on the Plan
Toxicities will be graded according to CTCAE v. 4.0.
Who Took Part
Enrollment: 69 actual participants took part.
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: Pathologic confirmation of NSCLC. Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Unresectable phase IIIA-IIIC lung cancer confirmed by PET/CT, CT or MRI. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Previously treated with chemotherapy or treatment-naive.
The full record lists 13 inclusion and 11 exclusion criteria; among the exclusions: previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ; contraindication for chemotherapy; malignant pleural or pericardial effusion.
How the Study Was Run
It was run as a single-group and open-label study.
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 2018-08-09 with completion listed for 2021-09-30.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version) (time frame: 1-year).
It also tracked 3 secondary outcomes, for example Total lymphocyte count, C-reaction protein and grade of pulmonary fibrosis (CTCAE 5.0 version).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Thymosin Alpha-1 in 69 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Thymosin Alpha-1 compound page, all human trials.
Our Notes on the Compound
Thymosin Alpha-1: An immune-modulating thymic peptide that recalibrates T-cell function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.