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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

December 31, 2019

Study Completion Date

January 31, 2020

Conditions
EGFR Mutation Positive Non Small Cell Lung Cancer
Interventions
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.

Trial Locations (5)

Unknown

Azienda Sanitaria Locale Frosinone, Frosinone

Istituto Nazionale dei Tumori, Milan

Roma_Campus Bio-Medico, Rome

Sant'Andrea Hospital, Rome

Presidio Sanitario San Camillo, Torino

Sponsors
All Listed Sponsors
lead

SciClone Pharmaceuticals

INDUSTRY