EUCTR2006-005905-79-GB进行中（未招募）1 期
A Phase 2 Randomized Study of Tarceva® (erlotinib) as a Single Agent or Intercalated with Combination Chemotherapy in Patients with Newly Diagnosed Advanced Non-Small Cell Lung Cancer who have Tumors with EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- •1)Histologically or cytologically (fine needle aspirate [FNA], sputum sample, or bronchial washing/lavage) documented advanced (stage IIIB or IV) NSCLC;
- •2)Age equal to or greater than 18 years;
- •3)ECOG PS 0, 1, or 2;
- •4)Predicted life expectancy equal to or greater than 12 weeks;
- •5)No prior therapy for advanced (stage IIIB or IV) NSCLC;
- •6)Prior to randomization, at least 1 of the 2 EGFR pathway markers must be positive
- •7)Radiologically measurable or evaluable disease as defined in Section 9.3.1.3;
- •8)Adequate hematopoietic, hepatic and renal function defined as follows:
- •-ANC equal to or greater than 1.5 x 10^9/L and platelet count equal to or greater than 100 x 10^9/L;
- •-Bilirubin less than or equal to 1.5 times the ULN, ALT (SGPT) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN in case of liver metastases);
- •-Serum creatinine less than or equal to 1.5 x ULN;
- •9)Accessible for repeat dosing and follow-up;
- •10)Patients with reproductive potential (eg, females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 2 weeks after completion of study drug therapy. Female patients of child-bearing potential must provide a negative pregnancy test (serum or urine) less than or equal to 7 day prior to randomization;
- •11)Written informed consent to participate in the study according to the IRB.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
- •1)Any prior or concurrent anticancer therapy (surgery, radiation, chemotherapy, or molecularly-targeted therapy) for advanced NSCLC, with the exception of surgical resection of an isolated brain metastasis and palliative radiation therapy. The patient must have fully recovered from surgery prior to the first dose of study drug. Palliative radiation therapy is allowed provided the treatment was not to the sole site of disease, concluded within 48 hours of first dose of study drug, and the patient was free of toxicity;
- •2)Any prior treatment with an EGFR inhibitor (eg, erlotinib, gefitinib, cetuximab, panitumumab, lapatinib), including neoadjuvant or adjuvant;
- •3)Other malignancies from which the patient has NOT been disease free for at least 5 years, except for adequately treated basal cell or squamous cell skin cancer;
- •4)Uncontrolled brain metastases (symptomatic brain metastases that are potentially life-threatening or require active treatment). If prior palliative treatment for brain metastases was administered, the patient should be neurologically stable and off steroids for a minimum of 2 weeks. A baseline CT scan of the brain is not required to rule out metastases unless there is clinical suspicion of central nervous system (CNS) involvement;
- •5)Gastrointestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption;
- •6)Ocular inflammatory or infectious conditions that have not be completely resolved prior to randomization;
- •7)Peripheral neuropathy less than or equal to grade 2;
- •8)Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction (within the 3 months prior to randomization) or serious cardiac arrhythmia requiring medication;
- •9)Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol treatment;
- •10)Women who are pregnant or breast-feeding and women or men not practicing effective birth control;
- •11)Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent;
- •12)Allergic reaction to compounds of similar chemical composition to the study drugs (Tarceva, paclitaxel, and carboplatin or their excipients).
研究者
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