Back to resultsIcotinib in Previously Treated Non/Light-smoking Patients With Advanced Squamous Cell Lung Cancer
Primary Purpose
Squamous Cell Carcinoma of 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 Squamous Cell Carcinoma of Lung focused on measuring icotinib, SCC
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic or recurrent squamous cell lung cancer from the primary lesion and/or lymph nodes, stage IIIB or IV patients with non-smoking or light-smoking history.
- Failure of at least 1, and no more than 2, prior chemotherapy regimens for advanced disease (either due to progressive disease or toxicity).
- Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan.
- Be >= 18 years of age.
- Expected survival period over 12 weeks;
- ECOG PS 0-2. Adequate organ system function as defined within the protocol.
- Patients with a history of CNS metastases or cord compression are allowed if they have been definitively treated and are clinically stable.
- Consent compliance research plan and follow-up process, and be able to carry out oral therapy; Provision of written informed consent.
- In women of childbearing age, must be in before starting treatment within 7 day of urine pregnancy test and the result is negative, and not in the lactation period, and reproductive age men and women prior to entry into the study, the research process until 90 days after stopping all agree to use reliable methods of contraception;
- Weight loss =< 10% in past 6 months.
- Adequate tumor tissue for detection of molecular biomarkers.
Exclusion Criteria:
- Patients who have previously received treatment with EGFR-TKIs.
- Concomitant treatment with any other experimental drug under investigation or anti-tumor therapy;
- Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been definitively treated with radiation and/or surgery.
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Presence of uncontrolled pleural effusion or/and peritoneal effusion;
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
- Past or current history of neoplasm (other than the entry diagnosis) in past 5 years, with the exception of treated basal cell carcinoma or carcinoma in situ of the cervix, or other cancers cured by local therapy alone.
- Women who are lactating.or have positive pregnancy test.
Sites / Locations
- 79 Qingchun Road
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
one arm
Arm Description
Icotinib of routine dose Icotinib: 125mg, 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
1. Study Identification
Unique Protocol Identification Number
NCT02009605
Brief Title
Icotinib in Previously Treated Non/Light-smoking Patients With Advanced Squamous Cell Lung Cancer
Official Title
An Open-label, Single-armed Pilot Study to Evaluate the Efficacy of Icotinib in Previously Treated Non/Light-smoking Patients With Squamous Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to evaluate the efficacy of icotinib at routine dose in previously treated non/light-smoking patients with advanced squamous cell lung cancer.
Detailed Description
This study is designed to evaluate the efficacy of icotinib at routine dose in previously treated non/light-smoking patients with advanced squamous cell lung cancer. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Lung
Keywords
icotinib, SCC
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
one arm
Arm Type
Experimental
Arm Description
Icotinib of routine dose Icotinib: 125mg, oral administration, three times per day.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
BPI-2009
Intervention Description
125mg, 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
3 months
Other Pre-specified Outcome Measures:
Title
Life quality
Time Frame
14 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:
Histologically or cytologically confirmed metastatic or recurrent squamous cell lung cancer from the primary lesion and/or lymph nodes, stage IIIB or IV patients with non-smoking or light-smoking history.
Failure of at least 1, and no more than 2, prior chemotherapy regimens for advanced disease (either due to progressive disease or toxicity).
Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan.
Be >= 18 years of age.
Expected survival period over 12 weeks;
ECOG PS 0-2. Adequate organ system function as defined within the protocol.
Patients with a history of CNS metastases or cord compression are allowed if they have been definitively treated and are clinically stable.
Consent compliance research plan and follow-up process, and be able to carry out oral therapy; Provision of written informed consent.
In women of childbearing age, must be in before starting treatment within 7 day of urine pregnancy test and the result is negative, and not in the lactation period, and reproductive age men and women prior to entry into the study, the research process until 90 days after stopping all agree to use reliable methods of contraception;
Weight loss =< 10% in past 6 months.
Adequate tumor tissue for detection of molecular biomarkers.
Exclusion Criteria:
Patients who have previously received treatment with EGFR-TKIs.
Concomitant treatment with any other experimental drug under investigation or anti-tumor therapy;
Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been definitively treated with radiation and/or surgery.
Known severe hypersensitivity to icotinib or any of the excipients of this product.
Presence of uncontrolled pleural effusion or/and peritoneal effusion;
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Past or current history of neoplasm (other than the entry diagnosis) in past 5 years, with the exception of treated basal cell carcinoma or carcinoma in situ of the cervix, or other cancers cured by local therapy alone.
Women who are lactating.or have positive pregnancy test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Yi Na, Dr.
Email
tango654321@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Qiong, Dr.
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
79 Qingchun Road
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Qiong, Dr.
First Name & Middle Initial & Last Name & Degree
Zhao Qiong, Dr.
12. IPD Sharing Statement
Learn more about this trial
Icotinib in Previously Treated Non/Light-smoking Patients With Advanced Squamous Cell Lung Cancer
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