Non-small Cell Lung Cancer
Conditions
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.
Interventions
DRUGIcotinib
Icotinib is administered 125 mg three times per day.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year Survival Rates | 1 year | — |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference of disease-free survival by status of Bcl-2 interacting mediator of cell death | 2 years | Compare the disease-free survival between patients with positive Bcl-2 interacting mediator of cell death mutation and patients without this mutation. |
Countries
China
Outcome results
None listed