Description:
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.
Title
- Brief Title: EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
- Official Title: EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
Clinical Trial IDs
- ORG STUDY ID:
ShanghaiPH002
- NCT ID:
NCT03002844
Conditions
- Nonsmall Cell Lung Cancer
- EGFR Gene Mutation
Interventions
Drug | Synonyms | Arms |
---|
EGFR-TK Inhibitor | gefitinib | EGFR-TK Inhibitor |
EGFR-TKI | gefitinib | EGFR-TKI and Chemotherapy |
EGFR-TKI and Chemotherapy | EGFR-TKI and pemetrexed/gemcitabine and carboplatin | EGFR-TKI and Chemotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
EGFR-TKI and Chemotherapy | Experimental | gefitinib with pemetrexed/gemcitabine and carboplatin | - EGFR-TKI
- EGFR-TKI and Chemotherapy
|
EGFR-TK Inhibitor | Experimental | Gefitinib | |
Eligibility Criteria
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
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progress Free Survival |
Time Frame: | up to 12 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Survival |
Time Frame: | up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Overall Response Rate |
Time Frame: | up to 12 months |
Safety Issue: | |
Description: | |
Measure: | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |
Time Frame: | up to 12 months |
Safety Issue: | |
Description: | Safety |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Shanghai Pulmonary Hospital, Shanghai, China |
Last Updated
December 28, 2016