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Trial Title:
Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
NCT ID:
NCT01929200
Condition:
Non-small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
1-year treatment with icotinib
Description:
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.
Arm group label:
1-year treatment with icotinib
Other name:
Commana
Other name:
BPI-2009
Intervention type:
Drug
Intervention name:
2-year treatment with icotinib
Description:
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.
Arm group label:
2-year treatment with icotinib
Other name:
Commana
Other name:
BPI-2009
Summary:
This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating
such patients. The primary endpoint is to compare the recurrence-free survival after 1-year
or 2-year treatment with icotinib.
Detailed description:
Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung
cancer. However, few data on the treating time of adjuvant therapy is available. Here we
conduct a randomized, prospective study to compare the recurrence-free survival after 1-year
or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The patients signed the written informed consent
- The patients present with operable stage II-IIIA non-small-cell lung cancers with 19
or 21 exon mutation
- The patients have no history of anti-cancer therapies including chemotherapy,
radiation therapy
- The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
Exclusion Criteria:
- Patients with unresected tumor
- Wild EGFR type
- Allergic to the study drug
- Patients have severe non-cancerous diseases
- Patients are undergoing current administration of anti-cancer therapies, or are
attending some other clinical trials
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Yue Yang, MD
Phone:
86-10-88196568
Email:
zlyangyue@bjmu.edu.cn
Investigator:
Last name:
Yue Yang, MD
Email:
Principal Investigator
Start date:
August 2013
Completion date:
August 2017
Lead sponsor:
Agency:
Betta Pharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Betta Pharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on April 10, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01929200
