CTIS2022-502092-33-00招募中1 期
ETOP 23-22 RAISE: A single-arm phase II study of the addition of niraparib to anti-PD-L1 antibody maintenance in patients with SLFN11-positive, extensive-disease small cell lung cancer.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 44
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
- •Inclusion criteria for SLFN11-expression testing •Histologically or cytologically confirmed ED-SCLC (stage IV according to the 8th TNM classification). •Availability of FFPE tumour tissue for central testing of SLFN11. •Written IC for SLFN11-screening must be signed and dated by the patient and the investigator prior to sending any tumour material to the central laboratory. Most important inclusion criteria for trial participation (See Section 7.2 for the complete list): •High SLFN11-expression on FFPE tumour material SLFN11-expression is determined at the central screening laboratory in Basel. Overexpression is defined as detectable protein expression by IHC in =20% of tumour cells. •Patients must have received standard first-line chemo-immunotherapy, consisting of 4 cycles of platinum-etoposide chemotherapy in combination with an anti-PD-L1 antibody (atezolizumab or durvalumab). Patients who started the immunotherapy at chemotherapy cycle 2, are eligible. •Patients must not have progressed on the standard chemo-immunotherapy (as per RECIST v1.1) •Patients must be candidates for maintenance treatment with immune-checkpoint inhibition. •Adequate haematological, renal and liver function •ECOG PS 0-2 •Age =18 years •Written IC for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention
排除标准
- •Most important exclusion criteria (See Section 7.3 for the complete list): •Symptomatic brain metastases •Any clinically active cancer, other than SCLC •Consolidating thoracic radiotherapy •History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. •Any lung disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid). •Any serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator, would compromise the patient’s ability to complete the trial or interfere with the evaluation of the efficacy and safety of the protocol treatment. •Inadequately controlled hypertension, defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >95 mmHg. •History of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML). •Prior Reversible Encephalopathy Syndrome (PRES). •Severe renal or hepatic impairment. •Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels. •Treatment with live vaccine within 30 days before enrolment. •Judgment by the investigator that the patient is unlikely to comply with trial procedures, restrictions and requirements.
研究者
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