Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation

Study Overview
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Brief Summary
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Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.

Official Title
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Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA Non-small Cell Lung Cancer With EGFR-mutation: a Randomized, Positive-controlled, Phase 3 Study (EVIDENCE, CCTC-1501)

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Icotinib
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed non-small cell lung cancer after surgical resection Stage II-IIIA disease according to 7th edition of TNM staging Positive EGFR gene mutation (19/21) ECOG 0-1 At least 1-year life expectancy Adequate organ function 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 Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Pneumonectomy of right lung Any unresolved chronic toxicity from previous anticancer therapy Allergic to study drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: icotinib<br>125 mg three times daily (375 mg per day) orally for two years. | Drug: Icotinib<br>* 125 mg three times daily (375 mg per day) orally for two years.<br>* Other names: Conmana;|
| Active Comparator: standard chemotherapy<br>Vinorelbine 25 mg/m^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles. cisplatin 75 mg/m^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m^2, day 1)/cisplatin (75 mg/m^2, day 1) for 4 cycles. | Drug: Chemotherapy<br>* Vinorelbine 25 mg/m^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles, cisplatin 75 mg/m^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m^2, day 1)/cisplatin (75 mg/m^2, day 1) for 4 cycles.<br>* Other names: ALIMTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | The time from the date of randomization to death from any cause | 60 months |