A Single-arm, Phase II Study to Evaluate PD-L1 Expression in Non-Small Cell Lung Cancer Using the 99mTc Labelled Anti-PD-L1 Single Domain Antibody (NM-01)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- PD-L1 Expression Assessment using [99mTc]-NM-01 SPECT/CT
研究概览
简要总结
This study will measure PD-L1 expression in metastatic NSCLC (primary tumour and metastatic lesions) using [99mTc]-NM-01 SPECT/CT and compare to PD-L1 percentage expression determined by immunohistochemistry (IHC).
详细描述
A non-blinded, single centre, single interventional arm Phase II diagnostic imaging study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or above
- •Patients with histopathology confirmed untreated metastatic NSCLC scheduled for systemic anti-cancer therapy
- •ECOG status ≤ 1
- •Willingness and ability to comply with scheduled study visits and tests
排除标准
- •Pregnant or breast-feeding women
- •Concomitant uncontrolled medical conditions as per Investigator assessment
- •> 3 months between IHC PD-L1 and study recruitment
- •Significant abnormality of haematology (one or more of: Hb ≤ 90g/L, absolute neutrophil count (ANC) ≤1.5 x109/L, platelet count ≤75 x109/L)
- •Significant abnormality of renal function (defined as Cockcroft-Gault calculated creatinine clearance ≤30 mL/min)
- •Significant abnormality of liver function (one or more of: AST or ALT ≥2.5x ULN or ≥ 5x ULN if patient has liver metastases; total bilirubin ≥1.5xULN. In the case of patients with Gilbert's syndrome then direct bilirubin must be confirmed as ≤ ULN)
- •Significant cardiovascular disease, including New York Heart Association (NYHA) heart failure ≥Class III, myocardial infarction within 3 months of enrolment, unstable arrhythmia or unstable angina
- •History of uncontrolled allergic reactions and/or have hypersensitivity to anti-PD-L1 monoclonal antibodies, kanamycin A or aminoglycoside therapies, or other excipients that may induce hypersensitivity
研究组 & 干预措施
Metastatic Non-Small Cell Lung Cancer
Subjects with metastatic non-small cell lung cancer will be recruited as per protocol inclusion/exclusion criteria and will undergo [99mTc]-anti-PDL1 single-domain antibody ([99mTc]-NM-01) SPECT/CT imaging.
[99mTc]-NM-01 SPECT/CT images will be compared to immunohistochemistry PD-L1 expression results.
干预措施: [99mTc]-NM01 SPECT/CT (Diagnostic Test)
结局指标
主要结局
PD-L1 Expression Assessment using [99mTc]-NM-01 SPECT/CT
时间窗: Day 0
To measure PD-L1 expression in NSCLC (primary tumour and metastatic lesions) as assessed using \[99mTc\]-NM-01 SPECT/CT and compare to PD-L1 expression determined by IHC.
次要结局
- Safety of [99mTc]-NM-01 SPECT/CT assessed through incidence of Adverse Drug Reactions(Up to 12 days post-injection)
- PD-L1 expression heterogeneity as assessed by [99mTc]-NM-01 SPECT/CT tumour to blood-pool ratios in each lesion(Day 0)