Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

Study Overview
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Brief Summary
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The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

Detailed Description
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Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations. This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

Official Title
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A Multicenter, Randomized, Phase III Trial of Chemotherapy Followed by 6-month or 12-month Icotinib Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: 6-month Icotinib
* Drug: 12-month icotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent provided. Aged 18-75 years. Had completely resected pathological confirmed stage IIA-IIIA NSCLC. EGFR activating mutation in exon 19 or 21. Had completed four cycles of platinum-based adjuvant chemotherapy. Able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy. ECOG performance status of 0-1. Had a life expectancy of 12 weeks or more. Adequate hematological function, adequate liver function and renal function. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. 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 besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). 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: 6-month icotinib<br>Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months | Drug: 6-month Icotinib<br>* 125 mg three times daily (375 mg per day) by mouth for 6 months<br>* Other names: Conmana;|
| Experimental: 12-month icotinib<br>Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months | Drug: 12-month icotinib<br>* 125 mg three times daily (375 mg per day) by mouth for 12 months<br>* Other names: Conmana;|
| No Intervention: Chemotherapy alone<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-Free Survival | Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause. | 5 years after the last patient is randomized | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival was assessed from randomization to death as a result of any cause. | 5 years after the last patient is randomized | 
| Number of Participants with Adverse Events | To assess if the addition of icotinib to chemotherapy is safe. | 2 years | 
| Change from baseline in patient reported Lung Cancer Functional Assessment | Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire. | 2 years |