Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

Study Overview
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Brief Summary
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The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Detailed Description
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This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma. Primary Outcome Measure: Disease-free survival between Icotinib group and placebo group. Secondary Outcome Measures: Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

Official Title
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Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study

Conditions
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EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma

Intervention / Treatment
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* Drug: Icotinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed lung adenocarcinoma after surgical resection Stage II-IIIA disease according to 7th edition of TNM staging Patients must harbor sensitive EGFR gene mutation (19/21) Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy Exclusion Criteria: Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc Presence of metastatic disease Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Any unresolved chronic toxicity from previous anticancer therapy Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib<br>125 mg three times daily (375 mg per day) by mouth | Drug: Icotinib<br>* 125 mg three times daily (375 mg per day) by mouth<br>* Other names: Conmana;|
| Active Comparator: Placebo<br>1 tablet three times daily by mouth | Drug: Placebo<br>* 1 tablet three times daily by mouth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive. | 60 months | 
| Lung cancer symptoms and health-related quality of life (HRQoL) differences |  | 60 months | 
| Number of participants with adverse events |  | 36 months |