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High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

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ClinicalTrials.gov Identifier: NCT02960607
Recruitment Status : Unknown
Verified November 2016 by Yutao Liu, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 9, 2016
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Yutao Liu, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE November 8, 2016
First Posted Date  ICMJE November 9, 2016
Last Update Posted Date November 18, 2016
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2016)
Progression Free survival [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
Official Title  ICMJE A Phase II Study of High-dose Icotinib in Previously Treated Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Mutation
Brief Summary The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE Drug: Icotinib
Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.
Study Arms  ICMJE Experimental: Icotinib
250mg, tid until disease progression or unacceptable toxicities occurred
Intervention: Drug: Icotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2016)
25
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed stage IIIB/IV NSCLC
  • Investigator confirmed progression according RECIST 1.1 during previous icotinib treatment
  • Patients whose tumors:

    • are EGFR mutation-positive or
    • T790M mutation-negative
  • Performance status: WHO 0-2
  • Measurable disease according to RECIST 1.1

    • at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology
    • a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm
  • ANC ≥ 1.5*109/L, Platelets ≥ 75*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 × Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver metastases), Serum Creatinine ≤ 1.5 × ULN
  • Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
  • Patient must be able to comply with the protocol

Exclusion Criteria:

  • Patient with symptomatic central nervous system metastases
  • Patient has known active hepatitis B or C, or HIV infection
  • Pregnant or breastfeeding.
  • Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02960607
Other Study ID Numbers  ICMJE CH-L-059
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yutao Liu, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese Academy of Medical Sciences
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP