A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
研究概览
简要总结
This is a multi-center, open label, Phase 1b study of NXP900 in combination with lorlatinib in subjects with advanced, ALK-positive non-small cell lung cancer (NSCLC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Unresectable, metastatic or locally advanced ALK-positive NSCLC.
- •Must have received lorlatinib as first or second line TKI
- •One prior line of systemic chemotherapy is permitted
- •Must have tolerated the dose level of lorlatinib actively being explored in the study or a higher dose
排除标准
- •Known single or compound ALK domain mutations that cause resistance to lorlatinib, or known actionable oncogenic driver alterations other than ALK with approved targeted therapies available, such as, MET or EGFR mutations or HER2 overexpression
- •Any contraindications to treatment with lorlatinib according to the lorlatinib United States Prescribing Information (USPI)
研究组 & 干预措施
Dose Exploration
Escalating doses of NXP900 given with lorlatinib
干预措施: NXP900 (Drug)
Dose Exploration
Escalating doses of NXP900 given with lorlatinib
干预措施: Lorlatinib (Drug)
结局指标
主要结局
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
时间窗: Up to 30 days post treatment
Objective response rate (ORR)
时间窗: Up to approximately 12 months
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Duration of Response (DoR)
时间窗: Up to approximately 12 months
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Disease Control Rate (DCR)
时间窗: Up to approximately 12 months
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).
次要结局
未报告次要终点