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

NSCLC Clinical Trial

Official title:

Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02272127
• Other study ID #: NFEC-2014-069
• Status: Recruiting
• Phase: Phase 2
• First received: September 27, 2014
• Last updated: October 20, 2014
• Start date: July 2014
• Est. completion date: July 2019

Study information

• Verified date: October 2014
• Source: Nanfang Hospital of Southern Medical University
• Contact: Kaican Cai, MD
• Phone: 8620-61641822
• Email: doc_cai[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing completely resection of EGRF mutation-positive NSCLC

• Staging ?B (with high risk factor) to ?A

• 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• icotinib

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years	No
Secondary	Number of Participants with Adverse Effects		duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years	Yes