Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatment icotinib
Phase phase 2
Target EGFR
Sponsor Nanfang Hospital of Southern Medical University
Start date January 2011
End date January 2016
Trial size 50 participants
Trial identifier NCT02430974, NFYYXWK-CKC1102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).
(Experimental)
patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).Two weeks after chemotherapy completed, patients assigned to the consolidation therapy group began oral icotinib treatment (125 mg, thrice daily). Icotinib treatment continued for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity.
icotinib
Patients in experimental group will receive oral Icotinib for 4-8months.

Primary Outcomes

Measure
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

Measure
Number of Participants with Adverse Effects
time frame: duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Icotinib as Maintenance Treatment After Chemotherapy for Patients Undergoing Resection of EGRF Mutation-positive Non-small Cell Lung Cancer
Principal investigator Kaican Cai, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Nanfang Hospital of Southern Medical University.