Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer
Conditions
NSCLC
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
EGFR tyrosine kinase inhibitor
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: icotinib
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Kaican Cai, MD - 8620-61641822 - doc_cai@163.com
Start Date
July 2014
Completion Date
July 2019
Sponsors
Nanfang Hospital of Southern Medical University
Source
Nanfang Hospital of Southern Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page