Status:
COMPLETED
Preoperative Gefitinib for EGFR Mutant II-IIIa NSCLC (ECTOP-1001)
Lead Sponsor:
Fudan University
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1001. This is an open-label, single-arm, phase II interventional clinical trial. The investigator...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation.
- Clinically or pathologically confirmed stage II-IIIA
- Tolerable to complete resection of lung cancer
- Male or female aged 18 years and over
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications
- ECOG performance status 0-1.
- Life expectancy ≥12 weeks.
- Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 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 amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 x upper limit of normal (ULN).
- Adequate renal function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN), and creatinine clearance≥ 60 ml/min.
- Measurable disease according to the preset criteria .
Exclusion
- Known severe hypersensitivity to gefitinib or any of the excipients of this product
- Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
- Interstitial lung disease(ILD) or pulmonary fibrosis; impaired pulmonary function (e.g. FEV1 \<40% predicted value, artery blood gas PaO2\<60mmHg)
- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
- Previous or current malignancies of other histologies within the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free survival of 5 years; cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Eye inflammation or eye infection not fully treated or predisposing factor of this.
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
- Patient who has serious active infection
- Patients who harbouring exon 20 T790M mutation.
- Pregnancy or breast feeding.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01833572
Start Date
May 1 2013
End Date
October 1 2015
Last Update
July 12 2023
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032