EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT02859077

Collaborator

(none)

100

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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 chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Cancer	Drug: EGFR-TKI Drug: Chemotherapy（pemetrexed/gemcitabine） Drug: Chemotherapy（carboplatin）	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

EGFR-TKI With Chemotherapy as First Line Treatment in Stage IIIB/IV NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EGFR-TKI and Chemotherapy NSCLC patients	Drug: EGFR-TKI EGFR-TKI (gefitinib) Other Names: gefitinib Drug: Chemotherapy（pemetrexed/gemcitabine） Chemotherapy (pemetrexed/gemcitabine) Other Names: pemetrexed/gemcitabine Drug: Chemotherapy（carboplatin） Chemotherapy（carboplatin） Other Names: carboplatin

Arm

Intervention/Treatment

Experimental: EGFR-TKI and Chemotherapy

NSCLC patients

Drug: EGFR-TKI

EGFR-TKI (gefitinib)

Other Names:

gefitinib

Drug: Chemotherapy（pemetrexed/gemcitabine）

Chemotherapy (pemetrexed/gemcitabine)

Other Names:

pemetrexed/gemcitabine

Drug: Chemotherapy（carboplatin）

Chemotherapy（carboplatin）

Other Names:

carboplatin

Outcome Measures

Primary Outcome Measures

Progress Free Survival [1 year]

Secondary Outcome Measures

Overall Response Rate [1 year]
Overall Survival [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent Age >=18 years Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) 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 (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) 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