Clinical trial NCT01683175: Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Stage III
Keywords: Erlotinib
adjuvant therapy
radical operation
IIIA NSCLC
EGFR mutation
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2012-09-11
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 2-year disease free survival rate (DFSR)
timeFrame: 2 years
Secondary outcomes:
measure: disease free survival
timeFrame: 5 years
measure: overall survival (OS)
timeFrame: 5 years
measure: Quality of Life
timeFrame: 5 years
measure: Adverse Event (AE)
timeFrame: 5 years
measure: Serious Adverse Event (SAE)
timeFrame: 5 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Chengdu
country: China
facility: The second people's hospital of Sichuan
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: The third affiliated hospital of Harbin Medical Univer
city: Qingdao
country: China
facility: The affiliated hospital of medical college Qingdao University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Shijiazhuang
country: China
facility: Hebei Provincial Tumor Hospital
city: Suzhou
country: China
facility: The first affiliated hospital of Soochow University
city: Xi'an
country: China
facility: The fourth military medical university，Tangdu Hospital
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Changli Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yue D, Xu S, Wang Q, Li X, Shen Y, Zhao H, Chen C, Mao W, Liu W, Liu J, Zhang L, Ma H, Li Q, Yang Y, Liu Y, Chen H, Wang C. Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial. Lancet Respir Med. 2018 Nov;6(11):863-873. doi: 10.1016/S2213-2600(18)30277-7. Epub 2018 Aug 24.