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

NCT02906163

Phase 1/2 Unknown 188 enrolled SciClone Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject Thymalfasin Peptide
Background Afatinib Small molecule
Background Erlotinib Small molecule
Background Gefitinib Small molecule

Indications