Neoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.

Detailed Description
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Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.

Official Title
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Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation

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: 1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation. 3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy. 4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1. 5.The age of patient is ≥ 18 years old with a life expectancy longer than 3 months. Exclusion Criteria: 1. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug. 4. Patients have severe non-cancerous diseases. 5. Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.

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>Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery. | Drug: Icotinib<br>* Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.Icotinib is administered orally with a dose 125 mg 3 times daily.<br>* Other names: BPI-2009;|
| Active Comparator: Chemotherapy<br>Patients receive 8-week icotinib induction treatment before surgery and 4-cycle adjuvant chemotherapy with vinorelbine/cisplatin regimen after surgery. | Drug: Chemotherapy<br>* After surgery patients receive 4-cycle adjuvant chemotherapy with vinorelbine /cisplatin regimen, until untolerable toxicity or disease progression.<br>* Other names: Cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 8 weeks | 
| Disease free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pathological complete response rate after neoadjuvant therapy with icotinib |  | 8 weeks | 
| The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib |  | 8 weeks | 
| The resection rate of patients after neoadjuvant therapy with icotinib |  | 2 months |