drugset / Trial / NCT02906163
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
RandomizedParallel-groupOpen-labelTreatment
Summary
Phase I: evaluate the safety and tolerability two different dosing regimens of Thymosin alpha 1 in patients with advanced EGFR mutation positive NSCLC on Standard of Care (SoC) therapy. Phase II: evaluate the efficacy in terms of PFS of Thymosin alpha 1 in patients with advanced EGFR mutant NSCLC taking SoC as compared to SoC alone.
Timeline
- Start
- 2016-10
- Primary completion
- 2019-12
- Completion
- 2020-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thymalfasin | Peptide | — | — |
| Background | Afatinib | Small molecule | — | — |
| Background | Erlotinib | Small molecule | — | — |
| Background | Gefitinib | Small molecule | — | — |