Description:
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.
Title
- Brief Title: Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer
- Official Title: Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
NFEC-2014-069
- NCT ID:
NCT02272127
Conditions
Interventions
Drug | Synonyms | Arms |
---|
icotinib | | intercalated treatment |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
intercalated treatment | Experimental | Patients will receive 4 cycles treatment: chemotherapy(day 1) plus intercalated icotinib(day 8-21) every 3 weeks, and then oral icotinib continuously for 2 years or until disease progression or unacceptable toxic effects | |
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease free survival |
Time Frame: | from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of Participants with Adverse Effects |
Time Frame: | duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Nanfang Hospital of Southern Medical University |
Trial Keywords
- EGFR tyrosine kinase inhibitor
Last Updated
October 22, 2014