Chemotherapy of NSCLC With or Without Icotinib
This trial is active, not recruiting.
|Condition||carcinoma, non-small-cell lung|
|Sponsor||Nanfang Hospital of Southern Medical University|
|Start date||January 2011|
|End date||January 2016|
|Trial size||50 participants|
|Trial identifier||NCT02430974, NFYYXWK-CKC1102|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
Number of Participants with Adverse Effects
time frame: duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years
Male or female participants at least 18 years old.
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
|Official title||Icotinib as Maintenance Treatment After Chemotherapy for Patients Undergoing Resection of EGRF Mutation-positive Non-small Cell Lung Cancer|
|Principal investigator||Kaican Cai, MD|
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