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

Phase 2

• Conditions: Nonsmall Cell Lung Cancer; EGFR Gene Mutation
• Interventions: Drug: EGFR-TK Inhibitor; Drug: EGFR-TKI; Drug: EGFR-TKI and Chemotherapy

• Registration Number: NCT03002844
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-21
• Last Update Submitted: 2016-12-25
• Study First Posted: 2016-12-26
• Last Update Posted: 2016-12-28
• Primary Completion: 2017-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGFR-TKI and Chemotherapy	EGFR-TKI and Chemotherapy	gefitinib with pemetrexed/gemcitabine and carboplatin
EGFR-TK Inhibitor	EGFR-TK Inhibitor	Gefitinib
EGFR-TKI and Chemotherapy	EGFR-TKI	gefitinib with pemetrexed/gemcitabine and carboplatin

Primary Outcome Measures

Name	Time	Method
Progress Free Survival	up to 12 months

Secondary Outcome Measures

Name	Time	Method
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