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EGFR-TKI With 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: NCT02859077
Recruitment Status : Unknown
Verified August 2016 by Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China.
Recruitment status was:  Not yet recruiting
First Posted : August 8, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Caicun Zhou, 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 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
Non-Small-Cell Lung Cancer Drug: EGFR-TKI Drug: Chemotherapy(pemetrexed/gemcitabine) Drug: Chemotherapy(carboplatin) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EGFR-TKI With Chemotherapy as First Line Treatment in Stage IIIB/IV NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
Study Start Date : August 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Pemetrexed

Arm Intervention/treatment
Experimental: EGFR-TKI and Chemotherapy
NSCLC patients
Drug: EGFR-TKI
EGFR-TKI (gefitinib)
Other Name: gefitinib

Drug: Chemotherapy(pemetrexed/gemcitabine)
Chemotherapy (pemetrexed/gemcitabine)
Other Name: pemetrexed/gemcitabine

Drug: Chemotherapy(carboplatin)
Chemotherapy(carboplatin)
Other Name: carboplatin




Primary Outcome Measures :
  1. Progress Free Survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 1 year ]
  2. Overall Survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

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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:

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


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): NCT02859077


Contacts
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Contact: Caicun Zhou, MD, PHD +8613301825532 caicunzhoudr@163.com
Contact: Yayi He, MD, PHD +8613818828623 doctorjael@qq.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
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Responsible Party: Caicun Zhou, Prof. Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT02859077    
Other Study ID Numbers: ShanghaiPH01
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share the analysis data.
Keywords provided by Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China:
NSCLC
BIM
EGFR mutation
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