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

NCT ID: NCT03002844

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Nonsmall Cell Lung Cancer EGFR Gene Mutation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EGFR-TKI and Chemotherapy

gefitinib with pemetrexed/gemcitabine and carboplatin

Group Type EXPERIMENTAL

EGFR-TKI

Intervention Type DRUG

EGFR-TKI (gefitinib 250mg per day)

EGFR-TKI and Chemotherapy

Intervention Type DRUG

pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w

EGFR-TK Inhibitor

Gefitinib

Group Type EXPERIMENTAL

EGFR-TK Inhibitor

Intervention Type DRUG

EGFR-TKI (gefitinib 250mg per day)

Interventions

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EGFR-TK Inhibitor

EGFR-TKI (gefitinib 250mg per day)

Intervention Type DRUG

EGFR-TKI

EGFR-TKI (gefitinib 250mg per day)

Intervention Type DRUG

EGFR-TKI and Chemotherapy

pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w

Intervention Type DRUG

Other Intervention Names

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gefitinib gefitinib EGFR-TKI and pemetrexed/gemcitabine and carboplatin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Caicun Zhou

Director Head of Medical Oncology, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caicun Zhou, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Tongji University

Central Contacts

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Caicun Zhou, MD PHD

Role: CONTACT

Phone: 8613301825532

Email: [email protected]

Other Identifiers

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ShanghaiPH002

Identifier Type: -

Identifier Source: org_study_id