NL-OMON56015招募中2 期
Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer - ImmunoSABR Phase 2 trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 56
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
- •The study population consists of adult, squamous and non-squamous, non-small
- •cell lung cancer patients with Stage IV metastatic disease (up to 10
- •metastases).
排除标准
- •More than 10 metastatic lesions
- •More than 2 brain metastatic lesions
- •Two brain metastases with a cumulative diameter larger than 5 cm.
- •Patients with non-infectious pneumonitis, uncontrolled thyroid disease
- •pleuritis, pericarditis
- •peritonitis carcinomatosis, severe pleuritis and pleuritis
- •carcinomatosis
- •Patients who received live vaccines 30 days or fewer prior to
- •enrolment.(Patient can still participate after this is reached.)
- •Patients who are already actively participating in another study
- •Previous radiotherapy to an area that would be re-treated by (SAB)R resulting
- •in overlap of the
- •high dose areas
- •Patients that need (maintenance) chemotherapy during ImmunoSABR in the E-arm
- •Pregnancy or breast feading; it is well known that ED-B, the target of both
- •L19-IL2, is
- •expressed in a variety of fetal tissues. Furthermore, anti-PD(L)1
- •treatment may increase the
- •risk of immune-mediated disorders. Therefore it will be contra
- •indicated for pregnant or
- •lactating women.
- •Non-sterilised, sexually active male patient with a female partner who
- •is of child-bearing age,
- •must use two acceptable birth control methods like a condom combined
- •with spermicidal cream
- •or gel from the first dose of study medicine
- •Women of childbearing potential (WOCBP) and WOCPD partners of male
- •patients must be
- •using, from the screening to three months following the last study drug
- •administration and 45
- •months after last dose of antanti-PD(L)1 maintenance treatment,
- •effective contraception
- •methods ((a) IUD (IUD) or intrauterine hormone delivery system (IUS), b)
- •combined (with estrogen and progesterone) hormonal contraception associated
- •with ovulation inhibition (oral, intravaginal, transdermal), c) hormonal
- •contraception with progesterone only associated with ovulation inhibition
- •(oral, injectable, implantable),
- •Whole brain radiotherapy (WBRT) is not allowed, although it is accepted when
- •given at least 3 weeks prior to randomisation or after the treatment period.
- •Patients with stable brain metastases are not excluded.
- •Excluded are those with (non-)infectious pneumonitis and uncontrolled thyroid
- •disease,. as well as infectious pericarditis, infectious pleuritis or
- •infectious peritonitis. Patients become eligible once treated and stable
- •(thyroid disease) or recovered (note: patients with a medical history of
- •immunotherapy induced pneumonitis grade 3 or higher are always excluded).
- •Patients with pericarditis carcinomatosa, pleuritis carcinomatosa or
- •peritonitis carcinomatosa are excluded (based on Dingemans et al, JTO 2019;
- •Lievens et al, R&O 2021). Patients with a small amount of pericardial, pleural
- •or peritoneal fluid, and no diagnosis of malignant cells in this fluid (at
- •least once evaluation), or with so little fluid that cytological evaluation is
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研究者
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