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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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

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Non-small-cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1-year treatment with icotinib

Patients will receive 1-year treatment with icotinib after operation.

Group Type EXPERIMENTAL

1-year treatment with icotinib

Intervention Type DRUG

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 icotinib

Patients will receive 2-year treatment with icotinib after operation.

Group Type EXPERIMENTAL

2-year treatment with icotinib

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Commana BPI-2009 Commana BPI-2009

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No