Chemotherapy of NSCLC With or Without Icotinib

Nanfang Hospital, Southern Medical University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

IcotinibDRUG

Patients in experimental group will receive oral Icotinib for 4-8months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Number of Participants with Adverse Effects

Time frame: duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years

Data from ClinicalTrials.gov

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