2024-515555-38-01招募中2 期
A Phase II, Open-Label, Single Arm, prospective, multicenter study of niraparib plus dostarlimab in patients with advanced non-small cell lung cancer and/or malignant pleural mesothelioma, and positive for PD-L1 expression and germline or somatic mutations in the HRR genes
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 19
- 主要终点
- To evaluate the progression free survival (PFS)
研究概览
简要总结
To evaluate the progression free survival (PFS)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis (cyto or histological) of Mesothelioma or non-small cell lung cancer EGFR / ALK / ROS1 in advanced wild type - Disease progression to at least one previous systemic therapy line - Presence of germline and / or somatic mutations in DNA shelter genes and PD-L1 expression = 1% - Informed consent - Age over 18 and under 75 - Disease measurable according to RECIST criteria - Consent to biological material analysis (tissue biopsy) - Performance status 0-1 - Adequate organ functions
排除标准
- •Participation in other clinical studies - Presence of EGFR gene sensitizing mutations or ALK / ROS1 rearrangements - Immunodeficiency diagnosis - History of tuberculous infection - Known hypersensitivity to Niraparib or Dostarlimab, or excipients - Previous diagnosis of myelodysplastic syndrome or acute myeloid leukemia - Other known malignancy requiring active treatment - Diagnosis of autoimmune diseases Current or past non-infectious pneumonia treated with steroids or evidence of interstitial lung disease - Symptomatic cerebral or leptomeningeal metastases - Known medical conditions that may in some way preclude participation in the study because they confuse the results of the study itself or interfere with the participation of the subject, at the discretion of the researchers involved - Psychiatric comorbidities that preclude participation in the study / informed consent - Pregnancy / breastfeeding - Previous therapy with PARP inhibitors (poly-adenosine diphosphate-ribose) - Previous therapy with anti PD-1 or PD-L1 agents - HIV infection - Hepatitis B infection - Vaccinations within 30 days from the start of the experimental treatment
结局指标
主要结局
To evaluate the progression free survival (PFS)
To evaluate the progression free survival (PFS)
次要结局
- To evaluate the objective response rate (ORR) To evaluate the duration of response (DOR) To evaluate the disease control rate (DCR) To evaluate the overall survival (OS) To evaluate the safety and tolerability of the combination of Niraparib and dostarlimab
研究者
Francesco Passiglia
Scientific
Universita' Degli Studi Di Torino
研究点 (19)
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