Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation
Information source: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-small Cell Lung Cancer Stage III
Intervention: Erlotinib (Drug); cis-platinum (Drug); Vinorelbine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Tianjin Medical University Cancer Institute and Hospital Official(s) and/or principal investigator(s): Changli Wang, Principal Investigator, Affiliation: Tianjin Medical University Cancer Institute and Hospital
Overall contact: Changli Wang, Phone: 8613821086868, Email: wangchangli@medmail.com.cn
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 2-year disease free survival rate (DFSR)
Secondary outcome: disease free survivaloverall survival (OS) Quality of Life Adverse Event (AE) Serious Adverse Event (SAE)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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 4 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.
Locations and Contacts
Changli Wang, Phone: 8613821086868, Email: wangchangli@medmail.com.cn
Beijing Cancer Hospital, Beijing, China; Active, not recruiting
Beijing Chest Hospital,Capital Medcial University, Beijing, China; Withdrawn
Chinese PLA General Hospital, Beijing, China; Not yet recruiting Xiangyang Chu, Phone: 8613501222241, Email: drchu301@yahoo.com.cn Xiangyang Chu, Principal Investigator
The second people's hospital of Sichuan, Chengdu, China; Active, not recruiting
Fujian Medical University Union Hospital, Fuzhou, China; Not yet recruiting Chun Chen, Phone: 8613365910325, Email: chenchun0209@163.com Chun Chen, Principal Investigator
Sun Yat-Sen University Cancer Center, Guangzhou, China; Not yet recruiting Lanjun Zhang, Phone: 8613902262187, Email: zhlanj@mail.sysu.edu.cn Lanjun Zhang, Principal Investigator
Zhejiang Cancer Hospital, Hangzhou, China; Active, not recruiting
The third affiliated hospital of Harbin Medical Univer, Harbin, China; Active, not recruiting
The affiliated hospital of medical college Qingdao University, Qingdao, China; Not yet recruiting Yi Shen, Phone: 8613605325078, Email: qdshenyi@163.com Yi Shen, Principal Investigator
Fudan University Shanghai Cancer Center, Shanghai, China; Not yet recruiting Haiquan Chen, Phone: 8613601973588, Email: hpchen1@yahoo.com Haiquan Chen, Principal Investigator
Zhongshan Hospital Fudan University, Shanghai, China; Active, not recruiting
Liaoning Cancer Hospital & Institute, Shenyang, China; Not yet recruiting Yongyi Liu, Phone: 8613898878448, Email: L24315516@sina.com Yongyi Liu, Principal Investigator
Hebei Provincial Tumor Hospital, Shijiazhuang, China; Active, not recruiting
The first affiliated hospital of Soochow University, Suzhou, China; Not yet recruiting Haitao Ma, Phone: 8613375182028, Email: mht7403@163.com Haitao Ma, Principal Investigator
The fourth military medical university,Tangdu Hospital, Xi'an, China; Active, not recruiting
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300060, China; Recruiting Changli Wang, Phone: 8613821086868, Email: wangchangli@medmail.com.cn Changli Wang, Principal Investigator
Additional Information
Starting date: August 2012
Last updated: June 12, 2013
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