Erlotinib Versus Vinorelbine/Cisplatin as Adjuvant Treatment in Stage IIIA NSCLC Patients With EGFR Mutations
NCT ID: NCT01410214
Last Updated: 2011-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2011-05-31
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Erlotinib arm
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
Erlotinib
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
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.
vinorelbine/cisplatin
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Erlotinib
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
vinorelbine/cisplatin
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Medical University Cancer Institute and Hospital
OTHER
Fudan University
OTHER
Zhejiang Cancer Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Sun Yat-sen University
OTHER
Chinese PLA General Hospital
OTHER
Qingdao University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Hebei Medical University Fourth Hospital
OTHER
The Second People's Hospital of Sichuan
OTHER
Chinese Lung Cancer Surgical Group
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Changli Wang
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiurted Hospital of Soochow University
Suzhou, Jiangsu, China
Qingdao University Medical College
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The Second People's Hospital of Sichuan
Chengdu, Sichuang, China
Tianjin Medical University Cancer Institute and Hospital
Tianji, Tianji, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Chao Lv
Role: primary
Tao Wang
Role: primary
Lanjun Zhang
Role: primary
Xinbo Liu
Role: primary
Changfa Qu
Role: primary
Haitao Ma
Role: primary
Yongjie Wang
Role: primary
Yihua Sun
Role: primary
Qiang Li
Role: primary
Xuefeng Kan
Role: primary
Xinming Zhou
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C-LCSG-001
Identifier Type: -
Identifier Source: org_study_id