EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Study Overview
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Brief Summary
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BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Detailed Description
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BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Official Title
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EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Conditions
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Nonsmall Cell Lung Cancer, EGFR Gene Mutation

Intervention / Treatment
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* Drug: EGFR-TK Inhibitor
* Drug: EGFR-TKI
* Drug: EGFR-TKI and Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) Must have measurable or non-measurable disease Must be able to comply with study and follow-up procedures Exclusion Criteria: Small cell, carcinoid, or mixed small cell lung cancer Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGFR-TKI and Chemotherapy<br>gefitinib with pemetrexed/gemcitabine and carboplatin | Drug: EGFR-TKI<br>* EGFR-TKI (gefitinib 250mg per day)<br>* Other names: gefitinib;Drug: EGFR-TKI and Chemotherapy<br>* pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w<br>* Other names: EGFR-TKI and pemetrexed/gemcitabine and carboplatin;|
| Experimental: EGFR-TK Inhibitor<br>Gefitinib | Drug: EGFR-TK Inhibitor<br>* EGFR-TKI (gefitinib 250mg per day)<br>* Other names: gefitinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress Free Survival |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | up to 24 months | 
| Overall Response Rate |  | up to 12 months | 
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Safety | up to 12 months |