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

Phase 2UnknownNCT01929200

Betta Pharmaceuticals Co., Ltd.120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Non-small-cell Lung Cancer

Interventions

1-year treatment with icotinibDRUG

Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.

2-year treatment with icotinibDRUG

Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Cancer hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Recurrence-free Survival

Time frame: 6 months

Secondary Outcomes

Overall survival

Time frame: 6 months

Central Contacts

Yue Yang, MD

CONTACT

86-10-88196568 zlyangyue@bjmu.edu.cn

Data from ClinicalTrials.gov

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