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Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01683175
Recruitment Status : Unknown
Verified October 2016 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 11, 2012
Last Update Posted : October 20, 2016
Roche Pharma AG
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 2-year disease free survival rate (DFSR) [ Time Frame: 2 years ]
    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 :
  1. disease free survival [ Time Frame: 5 years ]
    Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.

  2. overall survival (OS) [ Time Frame: 5 years ]
    Overall survival is defined as the time from randomization to death.

  3. Quality of Life [ Time Frame: 5 years ]
    The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)

  4. Adverse Event (AE) [ Time Frame: 5 years ]
    frequency of Adverse Event

  5. Serious Adverse Event (SAE) [ Time Frame: 5 years ]
    Frequency of Serious Adverse Event (SAE)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01683175

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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
Beijing Cancer Hospital
Beijing, China
Chinese PLA General Hospital
Beijing, China
The second people's hospital of Sichuan
Chengdu, China
Fujian Medical University Union Hospital
Fuzhou, China
Sun Yat-Sen University Cancer Center
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
The third affiliated hospital of Harbin Medical Univer
Harbin, China
The affiliated hospital of medical college Qingdao University
Qingdao, China
Fudan University Shanghai Cancer Center
Shanghai, China
Zhongshan Hospital Fudan University
Shanghai, China
Liaoning Cancer Hospital & Institute
Shenyang, China
Hebei Provincial Tumor Hospital
Shijiazhuang, China
The first affiliated hospital of Soochow University
Suzhou, China
The fourth military medical university,Tangdu Hospital
Xi'an, China
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Roche Pharma AG
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Principal Investigator: Changli Wang Tianjin Medical University Cancer Institute and Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital Identifier: NCT01683175    
Other Study ID Numbers: ML28280
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
adjuvant therapy
radical operation
EGFR mutation
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators