Chemotherapy of NSCLC With or Without Icotinib

Phase 2

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Icotinib

• Registration Number: NCT02430974
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2015-04
• Study First Submitted: 2015-04-26
• Study First Submitted QC: 2015-04-26
• Last Update Submitted: 2015-04-26
• Study First Posted: 2015-04-30
• Last Update Posted: 2015-04-30
• Primary Completion: 2016-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy & Icotinib	Icotinib	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.

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