Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Non-small-cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: 1-year treatment with icotinib
* Drug: 2-year treatment with icotinib


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-year treatment with icotinib<br>Patients will receive 1-year treatment with icotinib after operation. | Drug: 1-year treatment with icotinib<br>* Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.<br>* Other names: BPI-2009;|
| Experimental: 2-year treatment with icotinib<br>Patients will receive 2-year treatment with icotinib after operation. | Drug: 2-year treatment with icotinib<br>* Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.<br>* Other names: BPI-2009;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free Survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 6 months |