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

Phase 2

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: 2-year treatment with icotinib; Drug: 1-year treatment with icotinib

• Registration Number: NCT01929200
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-27
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22
• Primary Completion: 2015-12
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• The patients signed the written informed consent
• The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
• The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
• The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion Criteria

• Patients with unresected tumor
• Wild EGFR type
• Allergic to the study drug
• Patients have severe non-cancerous diseases
• Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-year treatment with icotinib	2-year treatment with icotinib	Patients will receive 2-year treatment with icotinib after operation.
1-year treatment with icotinib	1-year treatment with icotinib	Patients will receive 1-year treatment with icotinib after operation.

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival	6 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	6 months

Trial Locations

Locations (1)

Beijing Cancer hospital; 🇨🇳 Beijing, China