We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance

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: NCT02930954
Recruitment Status : Unknown
Verified October 2016 by Caicun Zhou, Tongji University.
Recruitment status was:  Not yet recruiting
First Posted : October 12, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Caicun Zhou, Tongji University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of combination of gefitinib and doublet chemotherapy or antiangiogenesis in advanced non-small cell lung cancer patients with EGFR activating mutation, accompanied with Bim deletion or low activating EGFR mutation abundance.

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer Drug: Gefitinib Drug: pemetrexed or gemcitabine plus carboplatin, Drug: bevacizumab Phase 2

Detailed Description:

BIM deletion polymorphism and low EGFR mutation abundance were poor clinical response markers to EGFR-TKIs in NSCLC patients who had EGFR mutations.This is a phase II clinical trial to investigate the efficacy of combination treatment for patients harboring risk factors.

Advanced EGFR mutated NSCLC Patients with Bim deletion or EGFR low mutation abundance were randomizely divided into three treatment groups:

A:Gefitinib 250mg Qd B:Gefitinib 250mg Qd combined with doublet chemotherapy: Pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days, Gemcitabine (1000 mg/m² days 1, day8, intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days C:Gefitinib 250mg Qd combined with bevacizumab 7.5mg/kg intravenously per 21 days.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Gefitinib With Chemotherapy or Anti-angiogenesis as 1st Line Treatment in Advanced NSCLC Patients Detected With Bim Deletion or Low EGFR Activating Mutation Abundance
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Gefitinib single agent
Advanced NSCLC patients with EGFR activating mutation (L858R, 19Del) received Gefitinib 250mg Qd orally until progression, intolerable toxicity or death.
 Drug: Gefitinib
Patients received Gefitinib 250mg Qd orally until disease progression, intolerable toxicity or death.
Other Name: Iressa
Experimental: Gefitinib combined with chemotherapy
Gefitinib 250mg Qd combined with pemetrexed or gemcitabine plus carboplatin: Pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days, Gemcitabine (1000 mg/m² days 1,d8, intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days
 Drug: Gefitinib
Patients received Gefitinib 250mg Qd orally until disease progression, intolerable toxicity or death.
Other Name: Iressa

Drug: pemetrexed or gemcitabine plus carboplatin,
doublet chemotherapy with pemetrexed or gemcitabine plus carboplatin per 3 weeks
Other Name: Alimita or Gimza
Experimental: Gefitinib combined with antiangiogenesis
Gefetinib 250mg Qd combined with bevacizumab 7.5mg/kg per 21 days
 Drug: Gefitinib
Patients received Gefitinib 250mg Qd orally until disease progression, intolerable toxicity or death.
Other Name: Iressa

Drug: bevacizumab
bevacizumab 7.5mg/kg intravenously per 3 weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 8 weeks ]
    From start of anti-cancer therapy untill progression or death


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 36 months ]
    evaluated in the 36th since treatment begain

  2. side effect [ Time Frame: 8 weeks ]
    toxicities related to anti-cancer therapy

  3. quality of life [ Time Frame: 24 months ]
    evaluated since treatment began


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented, locally advanced or recurrent (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV) non-small cell lung cancer, anti-cancer treatment naiive
  • EGFR exon 19 deletion or exon 21 L858R.
  • Bim deletion by realtime PCR, or low abundance for EGFR mutation, for 19Del less than 4.9%, for L858R less than 9.5%.
  • ECOG performance status of ≤ 1.
  • Patients must have measurable disease according to the RECIST (version 1.1) criteria.
  • Life expectancy of at least 12 weeks
  • Written (signed) informed Consent to participate in the study.
  • Adequate organ function as defined by the following criteria:

Liver function: SGOT (AST) and SGPT (ALT) ≤ 2.5 X ULN in the absence of liver metastases or up to 5 X ULN in case of liver metastases. Total bilirubin ≤ 1.5ULN.

Bone marrow function: Granulocyte count ≥ 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin ≥90g/dl.

Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min. (based on modified Cockcroft-Gault formula).

  • For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.

Exclusion Criteria:

  • Patients with prior chemotherapy or systemic anti-cancer therapy including target therapy targeting HER family members (such as erlotinib, gefitinib, cetuximab, trastuzumab, etc). Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before the enrollments.
  • Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  • Patients who have brain metastasis or spinal cord compression. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
  • Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
  • lactating women
  • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
  • Unwilling to write informed consent to participate in the study or unwilling to receive follow-up
  • Tumor invade big vessels or close to big vessels (less than 5mm)
  • Obvious cavity or necrosis formed in the tumor, Uncontrolled hypertension, Myocardial ischemia or infarction more than stage II, cardiac insufficiency. Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
  • Hemoptysis, more than 2.5ml daily
  • Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
  • Unhealed bone fracture or wound for long time
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02930954


Contacts
Layout table for location contacts
Contact: Caicun Zhou, MD,PhD 86-21-65115006 ext 3049 caicunzhoudr@163.com
Contact: shengxiang Ren, MD,PhD 86-21-65115006 ext 3050 harry_ren@126.com

Locations
Layout table for location information
China
Department of Oncology, Shanghai pulmonary hospital
Shanghai, China, 200433
Sponsors and Collaborators
Caicun Zhou
Investigators
Layout table for investigator information
Principal Investigator: Caicun Zhou, MD,PhD Shanghai Pulmonary Hospital, Tongji University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Caicun Zhou, Professor, doctor, Tongji University
ClinicalTrials.gov Identifier: NCT02930954    
Other Study ID Numbers: FK1408
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share the patient characteristics, results of test, treatment and outcome.
Keywords provided by Caicun Zhou, Tongji University:
NSCLC, EGFR, Bim, mutation abundance
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Bevacizumab
Carboplatin
Gemcitabine
Pemetrexed
Gefitinib
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors