NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.

Study Overview
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Brief Summary
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The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable stage III NSCLC harboring EGFR mutations.

Detailed Description
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Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. Gefitinib has shown great efficacy in NSCLC patients with EGFR mutations. This study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable EGFR mutant stage III NSCLC.

Official Title
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A Multicenter Phase II Trial of Neoadjuvant Gefitinib Followed by Surgery, Followed by Adjuvant Gefitinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutations.

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Gefitinib-surgery-gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Target population is unresectable stage III (III A-bulky N2, III B) NSCLC with EGFR activating mutation in exon 19 or 21 Written informed consent provided Aged 18-75 years Able to comply with the required protocol and follow-up procedures Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Had a life expectancy of 12 weeks or more Adequate hematological function, liver function and renal function Female participants should not be pregnant or breast-feeding Exclusion Criteria: Known severe hypersensitivity to gefitinib or any of the excipients of this product Inability to comply with protocol or study procedures Had had previous 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 Interstitial pneumonia 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 year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease) Known human immunodeficiency virus (HIV) infection Pregnancy or breast-feeding women History of neurologic or psychiatric disorders Ingredients mixed with small cell lung cancer patients

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Gefitinib-surgery-gefitinib. Induction gefitinib therapy was given for 8 weeks. Patients' resectability was assessed after 8-week gefitinib. Adjuvant gefitinib was given within 3-6 weeks after surgery until progression or unacceptable toxic effects. | Procedure: Gefitinib-surgery-gefitinib<br>* neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib<br>* Other names: neooadjuvant gefitinib followed by surgery and gefitinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resectability rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with perioperative complications |  | 1 year | 
| Event-free survival | Event-free survival was assessed from randomization to disease recurrence/progression or death from any cause. | 2 years after the last patient is randomized | 
| Overall survival | Overall survival was assessed from randomization to death from any cause. | 2 years after the last patient is randomized |