NCT02125240

Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Detailed description

This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma. Primary Outcome Measure: Disease-free survival between Icotinib group and placebo group. Secondary Outcome Measures: Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

Conditions

• EGFR Positive Non-small Cell Lung Cancer
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Icotinib	125 mg three times daily (375 mg per day) by mouth
DRUG	Placebo	1 tablet three times daily by mouth

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-12-01
• Completion: 2021-07-01
• First posted: 2014-04-29
• Last updated: 2018-07-16

Locations

11 sites across 1 country: China