Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

Study Overview
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Brief Summary
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This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) 19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.

Official Title
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A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation

Conditions
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Non-small Cell Lung Cancer Stage III

Intervention / Treatment
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* Drug: Erlotinib
* Drug: cis-platinum
* Drug: Vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution; Accept study adjuvant therapy within 6 weeks post radical operation; ECOP PS 0-1; Life expectancy ≥12 weeks; Hematology: absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin concentration ≥ 9.0 g/dL (permit to maintain hematologic criteria by blood transfusion); Liver Function: TBil ≤1.5xULN; ALT and AST ≤2.5xULN; Renal Function: Cr ≤1.25xULN, and Ccr ≥60ml/min; Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before study treatment; Signed inform consent form by patient or his/her legal representative; Comply with study protocol and procedure, and be able to take oral medication; Aged ≥18 years and ≦75 years; Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 30 days after their last dose of study therapy; Exclusion Criteria: Having treated by Her-Target therapy, i.e. erlotinib, gefitinib, cetuximab, trastuzumab; Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic therapy, target medication treatment (i.e. monoclonal antibody), investigational therapy; Having local radiotherapy of NSCLC; Upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer; The findings in radical operation are lymph nodes with extracapsular invasion, or fusion, or all of dissection lymph nodes positive by pathology; Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival,cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor); Confirmed recurrent cancer by Clinical objective evidence (pathology or radiography images) before the study adjuvant therapy; Known hypersensitivity to platinum, Vinorelbine, EGFR-TKI agents or relevant components in the formulation; Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection; Active interstitial lung disease (ILD) by any clinical evidence; patients with any co-morbidities, or motalic disorders, or any abnormal findings in physical examination or laboratory tests are suspected to have contraindication of study therapy or high risk of study treatment complications; Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, angina starting in latest 3 months, Congestive heart failure (NYHA ≥ II), myocardial infarction within 6 months prior enrollment, under medication treatment of severe arrhythmia, liver, renal or metabolic disease; know HIV infection Pregnant or breastfeeding women; ECOG PS ≥2; Mixed with small cell lung cancer; Other conditions investigators evaluate that patient is not eligible to this study.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Erlotinib 150mg daily oral up to 2 years | Drug: Erlotinib<br> <br> |
| Active Comparator: Arm 2<br>NP Chemotherapy for 4 cycles | Drug: cis-platinum<br> <br> Drug: Vinorelbine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year disease free survival rate (DFSR) | 2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | Disease free survival is defined as the time from randomization to disease recurrence or death which comes first. | 5 years | 
| overall survival (OS) | Overall survival is defined as the time from randomization to death. | 5 years | 
| Quality of Life | The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS) | 5 years | 
| Adverse Event (AE) | frequency of Adverse Event | 5 years | 
| Serious Adverse Event (SAE) | Frequency of Serious Adverse Event (SAE) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erlotinib, adjuvant therapy, radical operation, IIIA NSCLC, EGFR mutation