NSCLC
Conditions
Keywords
EGFR tyrosine kinase inhibitor
Brief summary
Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.
Interventions
DRUGicotinib
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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\<2 * 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 |
Countries
China
Contacts
Primary ContactKaican Cai, MD
Backup ContactSiyang Feng, MM
Outcome results
None listed