EUCTR2014-005586-75-ES进行中（未招募）不适用
A Randomized double-blind Phase II trial evaluating maintenance olaparib versus placebo in patients with platinum-sensitive advanced non-small cell lung cancer - PIPSe
Gustave Roussy0 个研究点目标入组 500 人开始时间: 2015年10月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- •Inclusion criteria for registration :
- •1.Provision of written informed consent to treatment and companion translational studies prior to any study specific procedures
- •2.Patients must be > 18 years of age.
- •3.Affiliation to an health insurance
- •4.Histological diagnosis of NSCLC
- •5.Advanced or metastatic disease (stage IIIB/IV)
- •6.Access to the original tumor biopsy or planning of a fresh tumor biopsy
- •7.Chemonaïve for NSCLC
- •8.Absence of EGFR-sensitising mutation or ALK translocation
- •9.ECOG Performance Status of 0-1
- •10.Fit to receive 4-6 cycles of platinum-based induction chemotherapy
- •11.Measurable lesions by RECIST v1.1 criteria, i.e. at least one lesion, not previously irradiated, that can be accurately measured at baseline as ? 10mm in the longest diameter (except lymph nodes that must have short axis ? 15mm) with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination and which is suitable for accurate repeated measurements.
- •12.Patients must have normal organ and bone marrow function measured within 14 days prior to administration of the platinum-based treatment
- •13.Evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 14 days of study treatment.
- •14.Both men and women (of childbearing potential) who are sexually active should accept to use adequate contraception, during and for at least 3 months post-treatment
- •15.Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •Inclusion criteria for the genomic DNA study :
- •1.Provision of informed consent for genomic DNA research.
- •Inclusion criteria for randomization :
- •1.Patients previously registered in the PIPSeN study
- •2.Evidence of radiological partial or complete response after induction chemotherapy according to RECIST v1.1 criteria
- •3.ECOG Performance Status of 0-1
- •4.Patients must have normal organ and bone marrow function measured within 14 days prior to administration of olaparib / placebo
- •5.Evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 14 days of study treatment.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Non-inclusion criteria for registration :
- •1.Uncontrolled or symptomatic brain metastases. Controlled brain metastases are defined as stable for 1 month. A scan to confirm the absence of brain metastases is not required. Corticosteroids therapy will be allowed if administered at a stable dose for at least one month before entering the trial.
- •2.Previous enrolment (or randomisation) in the present study
- •3.Previous chemotherapy treatment for NSCLC
- •4.Any previous treatment with a PARP inhibitor, including olaparib.
- •5.Patients receiving any radiotherapy or considering to require radiotherapy to the lung at the time of study entry or in the near future, except for palliative reasons. The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to inclusion.
- •6.Patients receiving the following classes of inhibitors of CYP3A4 (see Section 6.5 for guidelines and wash out periods).
- •7.Major surgery within 14 days of registration and patients who have not recovered from any effects of any major surgery.
- •8.Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, coronary artery disease, cardiomyopathy, uncontrolled hypertension, myocardial infarction in the last 3 months, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent.
- •9.Pregnant and/or breast-feeding women.
- •10.Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and/or are receiving antiviral therapy. Systematic serologies to confirm the absence of this disease are not required.
- •11.Patients with known active hepatic disease (i.e., Hepatitis B or C) Systematic serologies to confirm the absence of these diseases are not required.
- •12.Patients with a known hypersensitivity to olaparib/placebo, cisplatin, carboplatin, or other platinum containing compounds, or any of the excipients of the product.
- •13.Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of olaparib/placebo.
- •14.Symptomatic peripheral neuropathy ? grade 2
- •15.Patients with uncontrolled seizures
- •16.Enrolment in another clinical trial (except observational study).
- •Non-inclusion criteria for the genomic DNA study :
- •1.Previous allogeneic bone marrow transplant;
- •2.Blood transfusion in the last 120 days prior to entry to the study
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