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Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01683175
First received: August 30, 2012
Last updated: June 12, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer Stage III
Drug: Erlotinib
Drug: cis-platinum
Drug: Vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • 2-year disease free survival rate (DFSR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.


Secondary Outcome Measures:
  • disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.

  • overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from randomization to death.

  • Quality of Life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)

  • Adverse Event (AE) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    frequency of Adverse Event

  • Serious Adverse Event (SAE) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Frequency of Serious Adverse Event (SAE)


Estimated Enrollment: 94
Study Start Date: August 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Erlotinib 150mg daily oral up to 2 years
Drug: Erlotinib
Active Comparator: Arm 2
NP Chemotherapy for 4 cycles
Drug: cis-platinum Drug: Vinorelbine

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683175

Contacts
Contact: Changli Wang 8613821086868 wangchangli@medmail.com.cn

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Changli Wang    8613821086868    wangchangli@medmail.com.cn   
Principal Investigator: Changli Wang         
China
Beijing Cancer Hospital Active, not recruiting
Beijing, China
Beijing Chest Hospital,Capital Medcial University Withdrawn
Beijing, China
Chinese PLA General Hospital Not yet recruiting
Beijing, China
Contact: Xiangyang Chu    8613501222241    drchu301@yahoo.com.cn   
Principal Investigator: Xiangyang Chu         
The second people's hospital of Sichuan Active, not recruiting
Chengdu, China
Fujian Medical University Union Hospital Not yet recruiting
Fuzhou, China
Contact: Chun Chen    8613365910325    chenchun0209@163.com   
Principal Investigator: Chun Chen         
Sun Yat-Sen University Cancer Center Not yet recruiting
Guangzhou, China
Contact: Lanjun Zhang    8613902262187    zhlanj@mail.sysu.edu.cn   
Principal Investigator: Lanjun Zhang         
Zhejiang Cancer Hospital Active, not recruiting
Hangzhou, China
The third affiliated hospital of Harbin Medical Univer Active, not recruiting
Harbin, China
The affiliated hospital of medical college Qingdao University Not yet recruiting
Qingdao, China
Contact: Yi Shen    8613605325078    qdshenyi@163.com   
Principal Investigator: Yi Shen         
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, China
Contact: Haiquan Chen    8613601973588    hpchen1@yahoo.com   
Principal Investigator: Haiquan Chen         
Zhongshan Hospital Fudan University Active, not recruiting
Shanghai, China
Liaoning Cancer Hospital & Institute Not yet recruiting
Shenyang, China
Contact: Yongyi Liu    8613898878448    L24315516@sina.com   
Principal Investigator: Yongyi Liu         
Hebei Provincial Tumor Hospital Active, not recruiting
Shijiazhuang, China
The first affiliated hospital of Soochow University Not yet recruiting
Suzhou, China
Contact: Haitao Ma    8613375182028    mht7403@163.com   
Principal Investigator: Haitao Ma         
The fourth military medical university,Tangdu Hospital Active, not recruiting
Xi'an, China
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Roche Pharma AG
Investigators
Principal Investigator: Changli Wang Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01683175     History of Changes
Other Study ID Numbers: ML28280
Study First Received: August 30, 2012
Last Updated: June 12, 2013
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Erlotinib
adjuvant therapy
radical operation
IIIA NSCLC
EGFR mutation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014