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

Phase 2

• Conditions: NSCLC
• Interventions: Drug: icotinib

• Registration Number: NCT02272127
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-27
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-20
• Last Update Submitted: 2014-10-20
• Study First Posted: 2014-10-22
• Last Update Posted: 2014-10-22
• Primary Completion: 2017-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intercalated treatment	icotinib	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

Primary Outcome Measures

Name	Time	Method
Disease free survival	from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Effects	duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China