NCT06834074Available不适用
Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 79
研究概览
简要总结
The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.
详细描述
The purpose of this Expanded Access Program is to provide investigational ALK inhibitor, neladalkib (NVL-655), for eligible patients with ALK-positive locally advanced or metastatic NSCLC (ALK+ NSCLC) who have previously received an ALK tyrosine kinase inhibitor (TKI) or eligible patients with other ALK-positive solid tumors, and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.
研究设计
- 研究类型
- Expanded Access
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
- •Age ≥18 years.
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumors with a documented ALK rearrangement or activating ALK mutation.
- •Previously received at least one ALK TKI (for patients with NSCLC) or any prior therapy (for patients with other solid tumors), with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.
- •Enrollment in a clinical trial of neladalkib is not possible.
- •Adequate organ function and bone marrow reserve.
排除标准
- •Prior receipt of neladalkib.
- •Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.
- •Ongoing anti-cancer therapy.
研究者
研究点 (79)
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