The purpose of this study is to determine whether thalidomide can improve the effectiveness of the gefitinib in NSCLC patients with EGFR mutations.
Primary Objective: To determine the 1 year progression-free survival(PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations. Secondary Objectives: 1. To evaluate the objective response rate and 2 years overall survival of this combination therapy; 2. To evaluate the safety and tolerability of this combination therapy; 3. To acquire preliminary data regarding the effects of thalidomide on interleukin-2 level in serum. Treatment will be administered on an outpatient basis. Thalidomide starting at a dose of 50mg QD at night. After one week, increase the dose to 100mg QD at night. Aspirin will be administered at 100mg QD continuously. Gefitinib will be administered at 250mg QD continuously. Maintenance Therapy patients responding to this therapy will be maintained with gefitinib、thalidomide and aspirin. Duration of Therapy In the absence of treatment delays due to adverse events, treatment may continue until one of the following criteria applies: 1. Disease progression, 2. Intercurrent illness that prevents further administration of treatment, 3. Unacceptable adverse events(s), 4. Patient decides to withdraw from the study, or 5. General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
380
progression-free survival (PFS)
one year progression-free survival of the patients
Time frame: 1 year
Objective Response Rate (ORR)
the Objective Response Rate
Time frame: 2 years
Overall Survival (OS)
2 years Overall Survival
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.