NL-OMON39236已完成3 期
Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects with Previously Untreated Stage IV Squamous Non Small Cell Lung Cancer (NSCLC) - Gemcitabine/Carboplatin With or Without Iniparib in subjects with NSCLC.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Newly diagnosed, stage IV squamous NSCLC. 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 have 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 thoracic radiotherapy as definitive therapy for locally advanced nonsmall
- •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 initiation of study treatment.
- •5. Presence of evaluable (measureable or non-measureable) disease.
- •6. ECOG Performance Status of 0 or 1 (see Appendix A).
- •7. Laboratory values as follows:
- •· Absolute neutrophil count (ANC) >=1,500/mL and platelet count >=100,000/mL
- •(<=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). Calculated creatinine
- •clearance will be used to calculate carboplatin dose.
- •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 6 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. Sexually active men must agree to
- •use a medically acceptable form of birth control during treatment and at least 6 months
- •after the last dose. If a female partner becomes pregnant during the course of study the
- •treating physician should be informed immediately.
- •9. 18 years of age or older.
- •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/accessible, a patient will
- •still be eligible for enrollment into the study.
排除标准
- •1. Prior treatment with gemcitabine, carboplatin (except in the adjuvant setting), or
- •2. Past or current history of neoplasm other than the entry diagnosis, with the exception
- •of t1) reated non-melanoma skin cancer, 2) treated non-invasive or in-situ carcinoma of any primary site or 3) invasive cancers treated definitively, with treatment ending >5 years previously and no evidence of recurrence.
- •3. A history of active cardiac disease, within the previous 6 months, including any of the following:
- •· Malignant hypertension;
- •· Unstable angina;
- •· Congestive heart failure;
- •· Myocardial infarction within the previous 6 months;
- •· Symptomatic unstable or uncontrolled 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 treatment; (2) followup
- •scan shows no disease progression; (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, 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
- •12. Use of any non-approved or investigational agent <=30 days prior to
- •administration of the first dose of study drug. Patients may not receive any
- •other investigational or anti-cancer treatments while participating in this study
研究者
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