Back to resultsHigh-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility 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
Sites / Locations
- Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Icotinib
Arm Description
250mg, tid until disease progression or unacceptable toxicities occurred
Outcomes
Primary Outcome Measures
Progression Free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT02960607
First Posted
November 8, 2016
Last Updated
November 16, 2016
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02960607
Brief Title
High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Icotinib
Arm Type
Experimental
Arm Description
250mg, tid until disease progression or unacceptable toxicities occurred
Intervention Type
Drug
Intervention Name(s)
Icotinib
Intervention Description
Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.
Primary Outcome Measure Information:
Title
Progression Free survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yutao Liu
Email
13911901165@139.com
Facility Information:
Facility Name
Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yutao Liu, MD
Email
13911901165@139.com
12. IPD Sharing Statement
Learn more about this trial
High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
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