High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
NCT ID: NCT02960607
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
25 participants
INTERVENTIONAL
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Icotinib
250mg, tid until disease progression or unacceptable toxicities occurred
Icotinib
Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.
Interventions
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Icotinib
Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Yutao Liu
Associate Chief Physician
Locations
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Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Yutao Liu, MD
Role: primary
Other Identifiers
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CH-L-059
Identifier Type: -
Identifier Source: org_study_id