CTIS2023-508443-40-00招募中1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum Based Chemotherapy with Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL 1L) - 213400
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 644
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 65+（—）
- 性别
- All
入选标准
- •Participants must be =18 years of age. Note: Participants in Korea are eligible if they are =19 years of age at the time informed consent is obtained., Participants with toxicity from standard of care (SoC) 1L induction therapy must have recovered to a level of organ and bone marrow function as defined by Inclusion Criterion #8 and there is no ongoing toxicity of CTCAE Grade >=3., Participants must be able to swallow and retain orally administered study treatment., A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: •Is not a WOCBP. OR •Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, as described in Appendix 3, during the intervention period and for at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. •A WOCBP must have a negative pregnancy test (either a highly sensitive urine or a serum pregnancy test as required by local regulations) within 72 hours before the first dose of study treatment. •If a highly sensitive urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. •Additional requirements for pregnancy testing during and after study treatment are described in Section 6.6.2. •The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. See Appendix 3 for a list of acceptable birth control methods. Information must be captured appropriately within the site’s source documents., Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: •Refrain from donating sperm plus, either: •Be abstinent from sexual activity as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or •Must agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak; See Appendix 3), Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent. Participants must be informed that their participation is voluntary. Participants will be required to sign a statement of informed consent to participate in the study., Participants must have a histologically or cytologically confirmed diagnosis of NSCLC without known targetable driver alteration (either non-squamous or squamous histology; mixed histology is allowed) for which an approved targeted therapy is available in the 1L induction/maintenance therapy setting., Participants must have advanced (Stage IIIB or Stage IIIC, not amenable to definitive chemoradiotherapy [CRT]) or metastatic (Stage IV) NSCLC as defined by the AJCC 8th Edition Staging Manual., Participants must have completed at least 4 but no more than 6 cycles of standard of care first line platinum
排除标准
- •Participants have mixed small cell lung cancer or sarcomatoid variant NSCLC., Participants have received prior systemic cytotoxic chemotherapy (IV or intraperitoneal), biological therapy (including checkpoint inhibitor), or hormonal therapy for cancer, or received thoracic radiation therapy of >30 Gy within 6 months of the first dose of the start of standard of care first-line induction therapy., Participants have received live vaccine within 30 days of planned start of study randomization., Participants have known hypersensitivity to the components of niraparib, placebo, or pembrolizumab or their formulation excipients., Participants have undergone major surgery within 4 weeks of starting the first dose of study treatment or have not recovered from any effects of any major surgery., Participants have other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy., Participants have any clinically significant concomitant disease or condition (such as transfusion-dependent anemia or thrombocytopenia) that could interfere with, or for which the treatment might interfere with, the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the participants in this study., Participants have any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study requirements and/or follow up procedures. Those conditions should be discussed with the participants before study entry., Participants have high 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, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, active uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits obtaining informed consent., Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment., Participants have presence of hepatitis B surface antigen or a positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, participants with presence of hepatitis B core antibody should also be excluded., Participants have received prior PARP inhibitor(s) in prior lines of treatment., Participants have a known history of MDS or AML, Participants have a known history of active tuberculosis [Lewinsohn, 2017]., Participants have current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment., Participants have systolic BP >140 mmHg or diastolic BP >90 mmHg, Participants have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels., Participants have leptomeningeal disease, carcinomatous meningitis, symptomatic BM, or radiographic signs of CNS hemorrhage. Note: Participants with asymptomatic BM (ie, off corticosteroids and anticonvulsants for at least 7 days) are permitted., Participants have received colony-stimulating factors (eg, granulocyte macrophage colony-st
研究者
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