Overview

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

Status:
Unknown status

Trial end date:
2018-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Shanghai Pulmonary Hospital, Shanghai, China

Treatments:

Carboplatin
Gefitinib
Gemcitabine
Pemetrexed

Criteria

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