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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 survival

overall 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

Page last updated: August 23, 2015

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