Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
Conditions
Non-small-cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 1-year treatment with icotinib Type: Drug
Name: 2-year treatment with icotinib Type: Drug
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Beijing Cancer hospital
Beijing, China
Status: Recruiting
Contact: Yue Yang, MD - 86-10-88196568 - zlyangyue@bjmu.edu.cn
Start Date
August 2013
Completion Date
August 2017
Sponsors
Betta Pharmaceuticals Co.,Ltd.
Source
Betta Pharmaceuticals Co.,Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page