Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation
- Registration Number
- NCT02044328
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Inclusion Criteria
- The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma 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 ≤ 0-1
- The patients signed the written informed consent
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Icotinib Icotinib Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.
- Primary Outcome Measures
Name Time Method Disease-free survival 2 years
- Secondary Outcome Measures
Name Time Method 3-year Survival Rates 3 years Number of patients suffered adverse events 42 months Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0
1-year Survival Rates 1 year
Trial Locations
- Locations (1)
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China