Spots Global Cancer Trial Database for Icotinib for Completed Resected IB NSCLC With EGFR Mutation

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Trial Identification

Brief Title: Icotinib for Completed Resected IB NSCLC With EGFR Mutation

Official Title: A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation

Study ID: NCT02264210

Conditions

Lung Neoplasms

Squamous Cell Lung Cancer

Adenocarcinoma of the Lung

Adenosquamous Cell Lung Cancer

Large Cell Lung Cancer

Bronchial Neoplasms

Stage IB Non-small Cell Lung Cancer

Interventions

Icotinib

Study Description

Brief Summary: This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.

Detailed Description: Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR mutation.