Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type

PHASE2UnknownINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

May 31, 2019

Study Completion Date

July 31, 2019

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Thymalfasin (Thymosin alpha 1, Ta1)

Patients will be randomized to Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed.

DRUG

SoC (chemotherapy and platinum agent)

Patients will be randomized to SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed.

Trial Locations (8)

Unknown

Azienda Sanitaria Locale Frosinone, Frosinone

Istituto Nazionale dei Tumori, Milan

Roma_Campus Bio-Medico, Rome

Roma_Gemelli, Rome

Roma_Regina Apostolorum, Rome

Roma_Tor Vergata, Rome

Sant'Andrea Hospital, Rome

Presidio Sanitario San Camillo, Torino

Sponsors
All Listed Sponsors
lead

SciClone Pharmaceuticals

INDUSTRY