EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III NSCLC Patients With EGFR Mutations (EVENT Trial)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Rate of Mediastinal Nodal Clearance, Defined as Pathologically Negative N2 Disease in the Final Surgical Resection Specimen or Mediastinoscopy
研究概览
简要总结
This phase II trial studies how well erlotinib hydrochloride works before surgery in treating patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the rate of mediastinal nodal clearance and complete pathological response after neoadjuvant erlotinib (erlotinib hydrochloride) in patients with epidermal growth factor receptor (EGFR) mutated stage III non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To determine the progression free survival in patient population of EGFR mutated stage III NSCLC patients who are treated with neoadjuvant erlotinib therapy.
II. To determine the overall survival. III. To estimate the overall response rate from neoadjuvant erlotinib. IV. To estimate the surgical resection rate. V. To evaluate the safety of neoadjuvant erlotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven (either histologic or cytologic) diagnosis of stage IIIA or IIIB non-small cell lung cancer; (according to American Joint Committee on Cancer [AJCC] staging, 7th edition) within 4 weeks of registration; the patient should have histologically or cytologically confirmed N2 disease
- •Activating mutation in EGFR
- •No prior chemotherapy or radiation for lung cancer
- •Patients may be potentially resectable or unresectable
- •Stage III A or B disease, including no distant metastases- based on following diagnostic workup:
- •History/physical examination prior to registration
- •Computed tomography (CT) scan of the chest or positron emission tomography (PET) scan within 28 days of study entry
- •CT scan of abdomen or magnetic resonance imaging (MRI) of abdomen or PET scan within 28 days of study entry
- •An MRI of the brain or head CT scan with contrast within 28 days of study entry
- •Total body PET scan within 28 days of study entry
- •Mediastinoscopies are highly recommended
- •Patients must have measurable or evaluable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Absolute neutrophil count (ANC) >= 1,500 cells/ul
- •Platelets >= 100,000 cells/ul
- •Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= g/dl is acceptable)
- •Serum creatinine =< 1.5 x upper limit of normal (ULN)
- •Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x the ULN
- •Women of childbearing potential must have:
- •A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic gonadotropin [HCG]/L) within 72 hours prior to the start of study drug administration
- •Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
- •Ability to take oral medication
- •Patient must sign study specific informed consent prior to study entry
排除标准
- •Pleural or pericardial effusion
- •Pleural effusions allowed if one of the following conditions are met: 1) negative cytology after adequate sampling by thoracentesis 2) effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance
- •Severe, active co-morbidity, defined as follows:
- •Cardiac symptoms; any of the following should be considered for exclusion:
- •Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months)
- •Diagnosed congenital long QT syndrome
- •Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- •Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec)
- •History of significant bleeding disorder unrelated to cancer, including:
- •Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- •Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
- •Ongoing or recent (=< 3 months) significant gastrointestinal bleeding
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
- •Men and women who:
- •Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or women who:
- •Have a positive pregnancy test at baseline, or
- •Are pregnant or breastfeeding
研究组 & 干预措施
Treatment (erlotinib hydrochloride and thoracotomy)
Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.
干预措施: Erlotinib Hydrochloride (Drug)
Treatment (erlotinib hydrochloride and thoracotomy)
Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.
干预措施: Therapeutic Conventional Surgery (Procedure)
Treatment (erlotinib hydrochloride and thoracotomy)
Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Rate of Mediastinal Nodal Clearance, Defined as Pathologically Negative N2 Disease in the Final Surgical Resection Specimen or Mediastinoscopy
时间窗: 3 years 9 months
次要结局
未报告次要终点
研究者
Haiying Cheng
Principal Investigator
Albert Einstein College of Medicine