A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection

Study Overview
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Brief Summary
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This is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among EGFR mutant stage I lung adenocarcinoma patients, who have high-risk pathological features of recurrence.

Official Title
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A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection

Conditions
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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: Male or female, at least ≥ 18 years，and ≦ 80 years Lung adenocarcinoma. Stage I disease(IA or IB), based on TNM8 classification. There is at least one of the following high-risk factors: pathologically confirmed vascular invasion positive; pathologically confirmed lung adenocarcinoma containing solid or micropapillary or complex gland histology, with a percentage > 20%; pathologically confirmed invasive tumor size > 2 cm; pathologically confirmed visceral pleural involvement (T2a). Started adjuvant therapy in this study 4-6 weeks after complete resection without any previous antitumor therapy. A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) ,without KRAS mutation World Health Organization performance status of 0 or 1. Bood routine: HB > 80g/L; ANC > 1.0x109/L; PLT > 50x109/L.Blood biochemistry： ALT and AST < 2.5 times the upper limit of normal; Crea < 1.5 times the upper limit of normal. Good adherence to follow-up. During the trial and for 3 months after the trial，Participants must be using highly effective contraceptive measures. Exclusion Criteria: Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs). Local radiotherapy. Patients with cancers other than NSCLC (except cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumors) within 5 years prior to the start of treatment in this study. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, severe arrhythmia requiring medication, liver, kidney or metabolic disease). Any clinical evidence suggestive of active interstitial lung disease. An eye inflammation or eye infection that is not fully controlled, or any condition that could lead to one of these eye conditions. Known human immunodeficiency virus (HIV) infection. Known hypersensitivity to EGFR-TKI drugs or related components. Mixed small cell and non-small cell cancer history. Substance abuse, or illnesses such as psychological or psychiatric disorders that may interfere with study compliance. Patients with epilepsy requiring medication (e.g. steroids or anti-epileptic drugs). Other conditions deemed unsuitable for enrollment by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib<br>Icotinib oral 125mg tid for 2 years | Drug: Icotinib<br>* Within 4-6 weeks after surgery, Icotinib 125mg orally, TID was started for 2 years, or treatment was discontinued due to tumor recurrence or intolerance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-Free Survival (RFS) | RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first. | Up to approximately 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time from the date of randomisation until death due to any cause. | Up to approximately 10 years | 
| Safety and tolerability | AEs graded by CTCAE version 5.0 | Up to approximately 10 years |