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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: SciClone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase I/Phase II, multi-center, open label, randomized, parallel group study to determine the safety/tolerability/efficacy of Thymosin alpha 1 in patients with sensitizing EGFR mutation positive NSCLC taking SoC versus SoC alone. 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 I patients will be randomized to one of two different dosing regimens of Thymosin alpha 1 for a treatment duration of 4 months. At the completion of Phase I, data will be reviewed and a single dosing regimen will be carried forward into Phase II. In Phase II patients will be randomized to SoC or Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 18 months.

Conditions

• EGFR Mutation Positive Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Thymalfasin (Thymosin alpha 1, Ta1)	In Phase I patients will be randomized to one of two different dosing regimens of Thymosin alpha 1 for a treatment duration of 4 months. At the completion of Phase I, data will be reviewed and a single dosing regimen will be carried forward into Phase II.
DRUG	SoC (tyrosine kinase inhibitor)	In Phase II patients will be randomized to SoC or Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 18 months.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-12-01
• Completion: 2020-01-01
• First posted: 2016-09-19
• Last updated: 2016-09-19

Locations

5 sites across 1 country: Italy