Status:
UNKNOWN
Erlotinib Versus Gemcitabine/Cisplatin as (Neo)Adjuvant Treatment in Non-small Cell Lung Cancer
Lead Sponsor:
Guangdong Association of Clinical Trials
Collaborating Sponsors:
Guangdong Provincial People's Hospital
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Stage IIIA NSCLC represents a relatively heterogeneous group of pts with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of treatment modalities are not clearly defined. Concur...
Detailed Description
Concurrent Chemoradiation therapy remain the standard treatment for stage IIIA disease, but its treatment-related life threaten toxicity limit its use for those pts. Tarceva monotherapy have been dem...
Eligibility Criteria
Inclusion
- Written informed consent provided.
- Males or females aged ≥18 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Pathologically diagnosed of non-small cell lung cancer.
- Diagnosed as stage IIIA- N2.The diagnosis standard of N2 is as below: Pts with resectable stage IIIA-N2 NSCLC confirmed by mediastinoscopy or EBUS or PET/CT.
- EGFR activating mutation in exon 19 or 21 by the biopsy of primary tumor or N2 lymph node.
- Measurable disease must be characterized according to RECIST 1.1 criteria.
- Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10mm by spiral CT or MRI scan. The measurable criteria of lymph node is the short axis ≥ 15 mm.
- ECOG performance status 0-1.
- Life expectancy ≥12 weeks.
- 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 in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
- Female subjects should not be pregnant or breast-feeding.
Exclusion
- 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 (e.g. monoclonal antibody therapy).
- Resection of primary malignancy.
- EGFR mutation (exon 19 or 21) negative or unknown.
- Uncontrolled central nervous system (CNS) metastasis.
- History of another malignancy in the last 5 years with the exception of the following:Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- 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).
- Known hypersensitivity to Tarceva or gemcitabine or cisplatin.
- Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
- 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.
Key Trial Info
Start Date :
December 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01407822
Start Date
December 5 2011
End Date
December 1 2022
Last Update
September 11 2018
Active Locations (1)
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1
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080