Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to IIIA EGFR-mutated NSCLC.
Interventions
DRUGIcotinib
Patients in experimental group will receive oral Icotinib for 4-8months.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing completely resection of EGRF mutation-positive NSCLC * Staging ⅠB (with high risk factor) to ⅢA * PS = 0 or 1 * Adequate hematological, biochemical and organ functions
Exclusion criteria
* Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Effects | duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years |
Outcome results
None listed