Nonsmall Cell Lung Cancer, EGFR Gene Mutation
Conditions
Brief summary
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
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.
Interventions
EGFR-TKI (gefitinib 250mg per day)
DRUGEGFR-TKI
EGFR-TKI (gefitinib 250mg per day)
DRUGEGFR-TKI and Chemotherapy
pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) 3. Must have measurable or non-measurable disease 4. Must be able to comply with study and follow-up procedures
Exclusion criteria
1. Small cell, carcinoid, or mixed small cell lung cancer 2. Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer 3. Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC 4. 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 5. 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 6. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption 7. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival | up to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 12 months | Safety |
Contacts
Primary ContactCaicun Zhou, MD PHD
Outcome results
None listed