Back to resultsIcotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib of routine dose
Icotinib of high dose
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients with Histologic or cytologic confirmation.
- Wild type epidermal growth factor receptor status.
- Progressed after first-line chemotherapy.
- No previous systemic anticancer therapy.
- Measurable lesion according to response evaluation criteria in solid tumors with at least one measurable lesion not previously irradiated.
- Provision of written informed consent.
Exclusion Criteria:
- Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
- Positive epidermal growth factor receptor mutation.
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Sites / Locations
- Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Icotinib of routine dose
Icotinib of high dose
Arm Description
Icotinib: 125mg, oral administration, three times per day.
Icotinib: 375mg, oral administration, three times per day.
Outcomes
Primary Outcome Measures
Objective Response Rate
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, confirmed at least 28 days following the date of the initial response.
Secondary Outcome Measures
Progression free survival
Progression free survival was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
Overall survival
Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.
Number of Participants with Adverse Events
Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.
Full Information
NCT ID
NCT01744925
First Posted
December 5, 2012
Last Updated
February 6, 2017
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01744925
Brief Title
Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR
Official Title
An Open-label,Randomized,Controlled Study to Evaluate the Safety and Efficacy for Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Icotinib of routine dose
Arm Type
Active Comparator
Arm Description
Icotinib: 125mg, oral administration, three times per day.
Arm Title
Icotinib of high dose
Arm Type
Experimental
Arm Description
Icotinib: 375mg, oral administration, three times per day.
Intervention Type
Drug
Intervention Name(s)
Icotinib of routine dose
Other Intervention Name(s)
Conmana, BPI-2009
Intervention Description
Icotinib: 125mg, oral administration, three times per day.
Intervention Type
Drug
Intervention Name(s)
Icotinib of high dose
Other Intervention Name(s)
BPI-2009, Conmana
Intervention Description
Icotinib: 375mg, oral administration, three times per day.
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, confirmed at least 28 days following the date of the initial response.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
Time Frame
3 months
Title
Overall survival
Description
Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.
Time Frame
14 months
Title
Number of Participants with Adverse Events
Description
Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.
Time Frame
18 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:
Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients with Histologic or cytologic confirmation.
Wild type epidermal growth factor receptor status.
Progressed after first-line chemotherapy.
No previous systemic anticancer therapy.
Measurable lesion according to response evaluation criteria in solid tumors with at least one measurable lesion not previously irradiated.
Provision of written informed consent.
Exclusion Criteria:
Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
Positive epidermal growth factor receptor mutation.
Known severe hypersensitivity to icotinib or any of the excipients of this product.
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changli Wang, MD
Phone
86-022-23340123
Ext
3031
Email
wangchangli@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changli Wang, M.D.
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changli Wang
Email
wangchangli@medmail.com.cn
12. IPD Sharing Statement
Learn more about this trial
Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR
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