Back to resultsNeoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients
Primary Purpose
Non-small-cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation.
3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy.
4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1. 5.The age of patient is ≥ 18 years old with a life expectancy longer than 3 months.
Exclusion Criteria:
- 1. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug. 4. Patients have severe non-cancerous diseases. 5. Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.
Sites / Locations
- Zhejiang cancer hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Icotinib
Chemotherapy
Arm Description
Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.
Patients receive 8-week icotinib induction treatment before surgery and 4-cycle adjuvant chemotherapy with vinorelbine/cisplatin regimen after surgery.
Outcomes
Primary Outcome Measures
Objective response rate
Disease free survival
Secondary Outcome Measures
The pathological complete response rate after neoadjuvant therapy with icotinib
The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib
The resection rate of patients after neoadjuvant therapy with icotinib
Full Information
NCT ID
NCT01843647
First Posted
April 26, 2013
Last Updated
July 14, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01843647
Brief Title
Neoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients
Official Title
Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2018 (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
The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.
Detailed Description
Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.
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
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Icotinib
Arm Type
Experimental
Arm Description
Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Patients receive 8-week icotinib induction treatment before surgery and 4-cycle adjuvant chemotherapy with vinorelbine/cisplatin regimen after surgery.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
Commana, BPI-2009
Intervention Description
Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.Icotinib is administered orally with a dose 125 mg 3 times daily.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Vinorelbine, Cisplatin
Intervention Description
After surgery patients receive 4-cycle adjuvant chemotherapy with vinorelbine
/cisplatin regimen, until untolerable toxicity or disease progression.
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
8 weeks
Title
Disease free survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The pathological complete response rate after neoadjuvant therapy with icotinib
Time Frame
8 weeks
Title
The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib
Time Frame
8 weeks
Title
The resection rate of patients after neoadjuvant therapy with icotinib
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation.
3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy.
4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1. 5.The age of patient is ≥ 18 years old with a life expectancy longer than 3 months.
Exclusion Criteria:
1. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug. 4. Patients have severe non-cancerous diseases. 5. Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weimin Mao, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang cancer hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Mao, MD
Phone
86-571-88122182
First Name & Middle Initial & Last Name & Degree
Weimin Mao, MD
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients
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