Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

Tianjin Medical University

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer Stage III

Treatments: Drug: Vinorelbine; Drug: cis-platinum; Drug: Erlotinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01683175

ML28280

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Arm 1

Experimental group

Description:

Erlotinib 150mg daily oral up to 2 years

Treatment:

Drug: Erlotinib

Arm 2

Active Comparator group

Description:

NP Chemotherapy for 4 cycles

Treatment:

Drug: Vinorelbine

Drug: cis-platinum