Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer

Nanfang Hospital, Southern Medical University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

NSCLC

Interventions

icotinib

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\<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.

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

Central Contacts

Kaican Cai, MD

CONTACT

8620-61641822 doc_cai@163.com

Siyang Feng, MM