NSCLC Clinical Trial
Official title:
A Phase III, Multi Center, Randomized, Placebo Controlled Study to Evaluate the Efficacy of the Combination Gefitinib With Thalidomide in Patients With Locally Advanced and Metastatic Non-Small-Cell-Lung-Cancer With EGFR Mutation
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 gefitinibăthalidomide 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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