2025-522867-13-00已完成2 期
A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults with Non-Small Cell Lung Cancer in Combination with Pembrolizumab.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Merus B.V.
- 入组人数
- 90
- 试验地点
- 38
- 主要终点
- ORR per Investigator assessment using RECIST 1.1
研究概览
简要总结
To assess antitumor activity of petosemtamab in combination with pembrolizumab in NSCLC
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent and is willing and able to comply with all study procedures and contraception requirements (see Appendix 4)
- •Adequate hematologic function as defined below: a. Platelet count ≥ 100 × 109/L (without transfusion within the past 7 days) b. ANC ≥ 1.5 × 109/L c. Hemoglobin ≥ 9 g/dL (without transfusion within the past 7 days)
- •Creatinine clearance ≥ 60 mL/min calculated according to the Cockroft and Gault formula
- •Age ≥ 18 years at the signing of ICF
- •At least 1 measurable lesion as defined by RECIST 1.1 by radiologic methods and confirmed by the Investigator to meet both of the following criteria: a. Non-nodal lesion that measures ≥ 10 mm in the longest diameter or lymph node lesion that measures ≥ 15 mm in the short axis b. The lesion is suitable for repeat measurement using CT/MRI. Lesions that have had external beam radiotherapy or locoregional therapy must show radiographic evidence of subsequent growth.
- •ECOG performance status of 0 or 1
- •Life expectancy ≥ 12 weeks, in the opinion of the Investigator
- •Please refer to the protocol for further criteria
排除标准
- •Has untreated CNS metastases and/or carcinomatous meningitis a. Participants whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both obtained after treatment to the brain metastases at least 4 weeks apart, that show no evidence of intracranial progression) b. In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed at least 3 days prior to study medication.
- •Participation in an interventional clinical study with any investigational drug within 4 weeks prior to the first dose of study treatment OR participation in any clinical study with petosemtamab at any time prior to the first dose of study treatment, regardless of whether petosemtamab was received
- •Please refer to the protocol for further criteria
研究组 & 干预措施
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Test
干预措施: KEYTRUDA 25 mg/mL concentrate for solution for infusion. (Drug)
结局指标
主要结局
ORR per Investigator assessment using RECIST 1.1
ORR per Investigator assessment using RECIST 1.1
次要结局
- • AEs • Clinical laboratory data
- DoR per Investigator assessment using RECIST 1.1 • DCR per Investigator assessment using RECIST 1.1 • CBR per Investigator assessment using RECIST 1.1 • PFS per Investigator assessment using RECIST 1.1 • OS
- Integrated analysis using population PK model approach
- Please refer to Protocol for further secondary end points
研究者
Clinical Trial Information
Scientific
Merus N.V.
研究点 (38)
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