Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer Stage III | Drug: Erlotinib Drug: cis-platinum Drug: Vinorelbine | Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
Erlotinib 150mg daily oral up to 2 years
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Drug: Erlotinib |
Active Comparator: Arm 2
NP Chemotherapy for 4 cycles
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Drug: cis-platinum Drug: Vinorelbine |
- 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.
- 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.
- overall survival (OS) [ Time Frame: 5 years ]Overall survival is defined as the time from randomization to death.
- 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)
- Adverse Event (AE) [ Time Frame: 5 years ]frequency of Adverse Event
- Serious Adverse Event (SAE) [ Time Frame: 5 years ]Frequency of Serious Adverse Event (SAE)
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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.
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 ClinicalTrials.gov identifier (NCT number): NCT01683175
China, Tianjin | |
Tianjin Medical University Cancer Institute and Hospital | |
Tianjin, Tianjin, China, 300060 | |
China | |
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 |
Principal Investigator: | Changli Wang | Tianjin Medical University Cancer Institute and Hospital |
Responsible Party: | Tianjin Medical University Cancer Institute and Hospital |
ClinicalTrials.gov 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 |
Erlotinib adjuvant therapy radical operation IIIA NSCLC EGFR mutation |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Erlotinib Hydrochloride |
Cisplatin Vinorelbine Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |