Icotinib for Completed Resected IB NSCLC With EGFR Mutation

Study Overview
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Brief Summary
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This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.

Detailed Description
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Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR mutation.

Official Title
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A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation

Conditions
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Lung Neoplasms, Squamous Cell Lung Cancer, Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer, Bronchial Neoplasms, Stage IB Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Icotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent provided. Males or females, Aged 18-75 years. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. Had completely resected pathological confirmed stage IIA-IIIA NSCLC. EGFR activating mutation in exon 19 or 21. Patient who can start the investigational therapy within 3-6 weeks after the complete resection. ECOG performance status of 0-1. Had a life expectancy of 12 weeks or more. Adequate hematological function, adequate liver function and renal function. Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test. Exclusion Criteria: Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). Inability to comply with protocol or study procedures. Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder. Any evidence confirmed tumor recurrence before investigational therapy. Known severe hypersensitivity to icotinib or any of the excipients of this product. Evidence of clinically active interstitial lung disease. Eye inflammation not fully controlled or conditions predisposing the subject to this. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). Known human immunodeficiency virus (HIV) infection. Pregnancy or breast-feeding women. Ingredients mixed with small cell lung cancer patients. History of neurologic or psychiatric disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Icotinib 125 mg three times daily (375 mg per day) orally for 12 months. | Drug: Icotinib<br>* Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.<br>* Other names: Conmana;|
| No Intervention: Observation group<br>Observation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | DFS will be estimated by the method of Kaplan-Meier | From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS will be estimated by the method of Kaplan-Meier | From randomization to the time of death as a result of any cause, assessed up to 5 years | 
| Number of Participants with Adverse Events | The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used | Up to 5 years |