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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Icotinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of High-dose Icotinib in Previously Treated Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Mutation
Study Start Date : November 2016
Estimated Primary Completion Date : January 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Icotinib
250mg, tid until disease progression or unacceptable toxicities occurred
 Drug: Icotinib
Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free survival [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02960607


Contacts
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Contact: Yutao Liu 13911901165@139.com

Locations
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China
Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Yutao Liu, MD       13911901165@139.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
More Information
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Responsible Party: Yutao Liu, Associate Chief Physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02960607    
Other Study ID Numbers: CH-L-059
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
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