Back to resultsFirst-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
Primary Purpose
Non-Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Icotinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC, EGFR Mutation, Elder patients
Eligibility Criteria
Inclusion Criteria:
- Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
- Positive EGFR Mutation.
- No previous systemic anticancer therapy.
- Male and female patients aged over 70 years.
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
- 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).
- 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
- Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Icotinib
Arm Description
Icotinib: 125mg, oral administration, three times per day.
Outcomes
Primary Outcome Measures
Progression free survival
PFS 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.
Secondary Outcome Measures
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.
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 RECIST, confirmed at least 28 days following the date of the initial response.
Number of Participants with Adverse Events as a Measure of Safety
Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.
Full Information
NCT ID
NCT01646450
First Posted
July 17, 2012
Last Updated
September 5, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01646450
Brief Title
First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
Official Title
An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.
Detailed Description
A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.
Primary endpoint to assess progression-free survival
Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
NSCLC, EGFR Mutation, Elder patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Icotinib
Arm Type
Experimental
Arm Description
Icotinib: 125mg, oral administration, three times per day.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
BPI-2009, Commana
Intervention Description
Icotinib: 125mg, oral administration, three times per day.
Primary Outcome Measure Information:
Title
Progression free survival
Description
PFS 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
12 months
Secondary Outcome Measure Information:
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
24 months
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 RECIST, confirmed at least 28 days following the date of the initial response.
Time Frame
3-6 months
Title
Number of Participants with Adverse Events as a Measure of Safety
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
70 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
Positive EGFR Mutation.
No previous systemic anticancer therapy.
Male and female patients aged over 70 years.
Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Baohui, MD
Organizational Affiliation
Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
12. IPD Sharing Statement
Learn more about this trial
First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
We'll reach out to this number within 24 hrs