Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
Overview
- Phase
- Phase 2
- Intervention
- 1-year treatment with icotinib
- Conditions
- Non-small-cell Lung Cancer
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Recurrence-free Survival
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
1-year treatment with icotinib
Patients will receive 1-year treatment with icotinib after operation.
Intervention: 1-year treatment with icotinib
2-year treatment with icotinib
Patients will receive 2-year treatment with icotinib after operation.
Intervention: 2-year treatment with icotinib
Outcomes
Primary Outcomes
Recurrence-free Survival
Time Frame: 6 months
Secondary Outcomes
- Overall survival(6 months)