- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01410214
Erlotinib Versus Vinorelbine/Cisplatin as Adjuvant Treatment in Stage IIIA NSCLC Patients With EGFR Mutations
December 21, 2011 updated by: Chinese Lung Cancer Surgical Group
A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras
The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The LACE meta-analysis identified four cycles of platinum-based program to improve II~IIIA stage completely resected NSCLC pts the role of 5-year survival, but its treatment-related life threatening toxicity limits its use.
The EGFR tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating mutations in the metastatic setting.
The aim of this study is to investigate the efficacy and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in pts with stage IIIA NSCLC after Complete Resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xuefeng Kan
- Email: 13920870123@126.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100000
- Recruiting
- Beijing Cancer Hospital
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Principal Investigator:
- Yue Yang
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Contact:
- Chao Lv
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Beijing, Beijing, China, 100000
- Not yet recruiting
- Chinese PLA General Hospital
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Contact:
- Tao Wang
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Principal Investigator:
- Xiangyang Chu
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Not yet recruiting
- Sun Yat-sen University Cancer Center
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Contact:
- Lanjun Zhang
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Principal Investigator:
- Lanjun Zhang
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Hebei
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Shijiazhuang, Hebei, China, 050000
- Recruiting
- Hebei Medical University Fourth Hospital
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Contact:
- Xinbo Liu
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
- Recruiting
- Harbin Medical University Cancer Hospital
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Contact:
- Changfa Qu
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Principal Investigator:
- Shidong Xu
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Jiangsu
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Suzhou, Jiangsu, China, 215000
- Not yet recruiting
- The First Affiurted Hospital of Soochow University
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Contact:
- Haitao Ma
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Principal Investigator:
- Haitao Ma
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Shandong
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Qingdao, Shandong, China, 266000
- Not yet recruiting
- Qingdao University Medical College
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Contact:
- Yongjie Wang
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Principal Investigator:
- Yi Shen
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Shanghai
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Shanghai, Shanghai, China, 200000
- Not yet recruiting
- Fudan University Shanghai Cancer Center
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Contact:
- Yihua Sun
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Principal Investigator:
- Haiquan Chen
-
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Sichuang
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Chengdu, Sichuang, China, 610000
- Recruiting
- The Second People's Hospital of Sichuan
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Contact:
- Qiang Li
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Principal Investigator:
- Qiang Li
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Tianji
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Tianji, Tianji, China, 300000
- Recruiting
- Tianjin Medical University Cancer Institute and Hospital
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Contact:
- Xuefeng Kan
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Principal Investigator:
- Changli Wang
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Not yet recruiting
- Zhejiang Cancer hospital
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Contact:
- Xinming Zhou
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Principal Investigator:
- Weimin Mao
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent provided.
- Males or females aged ≥18 years.
- Chest CT, brain CT or MRI, ECT, abdominal and double-neck B-, or whole body PET-CT examination in 4 weeks before complete resection.
- Pathological diagnosed of non-small cell lung cancer.
- Diagnosed as stage IIIA.
- In 4 weeks after complete resection pts start to accept the adjuvant therapy in this study, previously did not receive any anti-tumor therapy.
- EGFR activating mutation in exon 19 or 21 and KARS
- ECOG performance status 0-1.
- Life expectancy ≥3 months.
- Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN.
- Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test. .
Exclusion Criteria:
- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Patients with prior chemotherapy or therapy with systemic anti-tumour therapy.
- Patients with prior radiotherapy.
- History of another malignancy in the last 5 years with the exception of the following:Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any evidence confirmed tumor recurrence before adjuvant treatment.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Any evidence of clinically active interstitial lung disease.
- Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
- Known human immunodeficiency virus (HIV) infection.
- Known hypersensitivity to Tarceva or NVB or cisplatin.
- Pregnancy or breast-feeding women.
- ECOG performance status ≥ 2.
- Ingredients mixed with small cell lung cancer patients
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Erlotinib arm
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
|
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
Other Names:
|
Active Comparator: Chemo arm
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
|
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival
Time Frame: 2 years
|
To evaluate Disease-free survival(DFS) of two groups
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events
Time Frame: 2 years
|
To evaluate the safety profile(Number of Participants with Adverse Events) of two group.
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2 years
|
Quality of Life (QOL)
Time Frame: 2 years
|
To evaluate the Quality of Life (QOL) of two group.
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2 years
|
overall survival (OS)
Time Frame: 2 years
|
To evaluate the overall survival (OS) of two groups
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Anticipated)
July 1, 2015
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
August 1, 2011
First Submitted That Met QC Criteria
August 4, 2011
First Posted (Estimate)
August 5, 2011
Study Record Updates
Last Update Posted (Estimate)
December 23, 2011
Last Update Submitted That Met QC Criteria
December 21, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
- Cisplatin
- Vinorelbine
Other Study ID Numbers
- C-LCSG-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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