Chemotherapy of NSCLC With or Without Icotinib

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Icotinib as Maintenance Treatment After Chemotherapy for Patients Undergoing Resection of EGRF Mutation-positive Non-small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02430974
• Other study ID #: NFYYXWK-CKC1102
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 26, 2015
• Last updated: April 26, 2015
• Start date: January 2011
• Est. completion date: January 2018

Study information

• Verified date: April 2015
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 2018
• Est. primary completion date: January 2016
• 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 = 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

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