EUCTR2010-019255-22-IT进行中（未招募）1 期
Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without BSI-201 (SAR240550) (a PARP1 Inhibitor) in Patients with Previously Untreated Stage IV Squamous Non Small Cell Lung Cancer (NSCLC) - ND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 825
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
- 性别
- All
入选标准
- •1. Newly diagnosed, stage IV squamous cell lung cancer. This includes patients who present with disseminated metastases, and those with a malignant pleural or pericardial effusion (i.e., formerly stage IIIB in the 6th TNM staging system). 2. Patients who have received prior adjuvant therapy for early-stage lung cancer are eligible if at least 12 months have elapsed from that treatment. 3. Histologically confirmed squamous cell bronchogenic carcinoma. Patients whose tumors contain mixed non-small cell histologies are eligible, as long as squamous carcinoma is the predominant histology. Mixed tumors with small cell anaplastic elements are not eligible. Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable. 4. Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Radiation therapy must have been completed >4 weeks prior to the date the Informed Consent is signed. 5. Presence of evaluable (measureable or non-measurable) disease. 6. ECOG Performance Status of 0 or 1 (see Appendix A). 7. Laboratory values as follows: - Absolute neutrophil count (ANC) >1,500/microL and platelets >100,000/microL (=72 hours prior to initial treatment). - Hemoglobin >9 g/dL (Note: Patients may be transfused or receive erythropoietin to maintain or exceed this level). - Bilirubin < ULN. - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 times the upper limit of normal if no liver involvement or =5 times the upper limit of normal with liver involvement. - Creatinine <2.0 mg/dL, or creatinine clearance >40 mL/min (as calculated by the Cockcroft-Gault method (see Section 8.3.3). 8. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment, and at least 3 months after the last dose of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. 9. >18 years of age. 10. Ability to understand the nature of this study, give written informed consent, and comply with study requirements. 11. Patients entering this study must be willing to provide tissue from a previous tumor biopsy (if available) for correlative testing. If tissue is not available, a patient will still be eligible for enrollment into the study
- •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
- •1. Prior treatment with gemcitabine, carboplatin (except in the adjuvant setting), or BSI-201. 2. Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy alone and a disease-free survival of >5 years. 3. A history of cardiac disease, as defined by: •Malignant hypertension •Unstable angina •Congestive heart failure •Myocardial infarction within the previous 6 months •Symptomatic cardiac arrhythmias 4. Active brain metastases. Patients with treated brain metastases are eligible, if (1) radiation therapy was completed at least 2 weeks prior to study entry; (2) follow up scan shows no disease progression; and (3) patient does not require steroids. 5. Women who are pregnant or lactating. 6. Any serious, active infection (> Grade 2) at the time of treatment. 7. A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. 8. A major surgical procedure, open biopsy, or significant traumatic injury =28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study. 9. Uncontrolled or intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. 10. History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results. 11. Known or suspected allergy/hypersensitivity to any agent given in the course of this trial
研究者
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