Clinical Trials /

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

NCT03002844

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
EGFR-TK InhibitorgefitinibEGFR-TK Inhibitor
EGFR-TKIgefitinibEGFR-TKI and Chemotherapy
EGFR-TKI and ChemotherapyEGFR-TKI and pemetrexed/gemcitabine and carboplatinEGFR-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

NameTypeDescriptionInterventions
EGFR-TKI and ChemotherapyExperimentalgefitinib with pemetrexed/gemcitabine and carboplatin
  • EGFR-TKI
  • EGFR-TKI and Chemotherapy
EGFR-TK InhibitorExperimentalGefitinib
  • EGFR-TK Inhibitor

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:Not yet recruiting
Lead Sponsor:Shanghai Pulmonary Hospital, Shanghai, China

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