NL-OMON53375尚未招募不适用
Adoptive TIL therapy in combination with chemoimmunotherapy in advanced NSCLC patients - TIL in NSCLC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >=18 years
- •Presence of measurable stable or progressive disease according to RECIST
- •version 1.1.
- •Patients must have histologically confirmed metastatic NSCLC with at least
- •one lesion -primary or metastatic- of sufficient size (> 1 cm in total)
- •amendable for biopsy and/or resection and must be willing to undergo such a
- •procedure for experimental purposes. Furthermore there must be at least one
- •other lesion to monitor response.
- •Patients must have radiological stable disease on standard of care first line
- •treatment with at least two courses of single agent immunotherapy or
- •chemoimmunotherapy or progressive disease on or after standard of care first
- •line treatment.
- •In case the lung cancer is characterized by an oncogenic driver, patients
- •must have exhausted all targeted therapies and platinum based chemotherapy.
- •Patients must have a clinical performance status of ECOG 0 or 1 and an
- •expected life expectancy of at least 3 months.
排除标准
- •Requirement for immunosuppressive doses of systemic corticosteroids (>10
- •mg/day prednisone or equivalent) or other immunosuppressive drugs within the
- •last 3 weeks prior to start of treatment.
- •Patients who have uncontrolled central nervous system (CNS) metastases.
- •Patients who have asymptomatic CNS metastases no greater than 1 cm before
- •resection of a tumor lesion for retrieval of TIL may be eligible.
- •All toxicities due to prior non-systemic treatment must have recovered to a
- •grade 1 or less. Patients may have undergone minor surgical procedures or focal
- •palliative radiotherapy (to non-target lesions) within the past 4 weeks, as
- •long as all toxicities have recovered to grade 1 or less.
- •Serious acute or chronic illnesses, e.g. active infections requiring
- •antibiotics, bleeding disorders, or other conditions requiring concurrent
- •medications not allowed during this study.
- •Active immunodeficiency disease or autoimmune disease requiring immune
- •suppressive drugs. Vitiligo is not an exclusion criterion.
研究者
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