NCT01929200

Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

Detailed description

Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	1-year treatment with icotinib	Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.
DRUG	2-year treatment with icotinib	Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-12-01
• Completion: 2017-08-01
• First posted: 2013-08-27
• Last updated: 2015-05-22

Locations

1 site across 1 country: China