Chemotherapy of NSCLC With or Without Icotinib

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Icotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02430974

NFYYXWK-CKC1102

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Chemotherapy

No Intervention group

Description:

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).

Chemotherapy & Icotinib

Experimental group

Description:

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.

Treatment:

Drug: Icotinib