Medical Access Program for Patritumab Deruxtecan (HER3 DXd, U3-1402)
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 21
研究概览
简要总结
The purpose of this Medical Access Program is to provide access to HER3-DXd for eligible patients with NSCLC who, in their treating physician's opinion, have an unmet clinical need which cannot be treated with approved and commercially available drugs and who cannot enter a clinical trial prior to commercial availability.
详细描述
This is a Medical Access Program which will be available to adult patients in the US with metastatic or locally advanced EGFRm NSCLC who have received at least 2 prior systemic therapies, who have no alternative commercially available treatment options, and are not able to enter a clinical trial.
In this Medical Access Program, eligible patients will be treated with HER3-DXd and will continue to receive treatment until any of the following occurs:
- Disease progression
- Unacceptable toxicity
- The benefit-risk no longer favors the individual
- HER3-DXd becomes commercially available in the US and reimbursement is approved for the concerned indication of the Medical Access Program.
- Withdrawal of consent
- Pregnancy
- Physician discretion
- Death
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
- 未提供
排除标准
- 未提供