Back to resultsIcotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
Primary Purpose
Non-small Cell Lung Cancer
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 Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with stage IIIB/IV non-small cell lung cancer
- Patients with uncommon epidermal growth factor receptor (EGFR) mutation
- Targeted-therapy-naive patients
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Evaluable target lesions according to RECIST 1.1 for tumour response assessment
Exclusion Criteria:
- Wild-type EGFR
- Positive 19 del and/or 21 L858R mutation
- Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
- Patients who have documented history of interstitial lung disease
Sites / Locations
- Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
icotinib
Arm Description
patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity
Outcomes
Primary Outcome Measures
progression-free survival
Secondary Outcome Measures
tumor response rate
overall survival
Full Information
NCT ID
NCT02961270
First Posted
November 6, 2016
Last Updated
November 10, 2016
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02961270
Brief Title
Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
Official Title
Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study
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
December 2017 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
icotinib
Arm Type
Experimental
Arm Description
patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Icotinib
Intervention Description
Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
10 months
Secondary Outcome Measure Information:
Title
tumor response rate
Time Frame
2 months
Title
overall survival
Time Frame
24 months
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:
Patients with stage IIIB/IV non-small cell lung cancer
Patients with uncommon epidermal growth factor receptor (EGFR) mutation
Targeted-therapy-naive patients
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Evaluable target lesions according to RECIST 1.1 for tumour response assessment
Exclusion Criteria:
Wild-type EGFR
Positive 19 del and/or 21 L858R mutation
Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
Patients who have documented history of interstitial lung disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shenyu Zhou, MD
Phone
86 13520852899
Email
typhoonwho@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengyu Zhou, MD
Organizational Affiliation
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengyu Zhou, MD
Email
typhoonwho@126.com
12. IPD Sharing Statement
Learn more about this trial
Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
We'll reach out to this number within 24 hrs