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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03002844
Recruitment Status : Unknown
Verified December 2016 by Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China.
Recruitment status was:  Not yet recruiting
First Posted : December 26, 2016
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nonsmall Cell Lung Cancer EGFR Gene Mutation Drug: EGFR-TK Inhibitor Drug: EGFR-TKI Drug: EGFR-TKI and Chemotherapy Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
Study Start Date : December 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: EGFR-TKI and Chemotherapy
gefitinib with pemetrexed/gemcitabine and carboplatin
 Drug: EGFR-TKI
EGFR-TKI (gefitinib 250mg per day)
Other Name: gefitinib

Drug: EGFR-TKI and Chemotherapy
pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w
Other Name: EGFR-TKI and pemetrexed/gemcitabine and carboplatin
Experimental: EGFR-TK Inhibitor
Gefitinib
 Drug: EGFR-TK Inhibitor
EGFR-TKI (gefitinib 250mg per day)
Other Name: gefitinib


Outcome Measures
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Primary Outcome Measures :
  1. Progress Free Survival [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: up to 24 months ]
  2. Overall Response Rate [ Time Frame: up to 12 months ]
  3. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: up to 12 months ]
    Safety


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002844


Contacts
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Contact: Caicun Zhou, MD PHD 8613301825532 caicunzhoudr@163.com

Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Principal Investigator: Caicun Zhou, MD, PHD Shanghai Pulmonary Hospital, Tongji University
More Information
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Responsible Party: Caicun Zhou, Director Head of Medical Oncology, Principal Investigator, Clinical Professor, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT03002844    
Other Study ID Numbers: ShanghaiPH002
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Carboplatin
Pemetrexed
Gefitinib
 Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors