EUCTR2018-002583-11-FR进行中（未招募）1 期
Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer
Maastricht University Medical Centre0 个研究点目标入组 126 人开始时间: 2019年2月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Oligometastatic disease (=5 metastasis)
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Histological confirmed limited metastatic adult NSCLC patients, regardless of the PD-L1 status.
- •oMaximum of 5 metastatic lesions, maximum one brain lesion is allowed
- •-SOC baseline imaging e.g. MRI and/or PET-CT and CT-brain or MRI brain and/or CT-scan with at least covering thorax-upper abdomen/brain,
- •within 6 weeks prior randomisation.
- •-If a patient has unclear lesions in the liver or brain, an MRI would be advised following the ESMO guidelines
- •oIn patients with 2 lung tumours, it can be unclear if the patient has 2 concurrent primary tumours or a primary lung tumour with 1 metastasis. In
- •this case, it is according to the decision of the local multidisciplinary tumour board whether the patient has an M1 disease or not.
- •Previous treatment:
- •oPrior cancer treatments are allowed but must be discontinued for at least 4 weeks before randomisation.
- •Age of 18 years or older.
- •WHO performance status 0-1;
- •Adequate bone marrow function (evaluated in the local lab): Absolute Neutrophil Count (ANC) of > or equal to 1.0 x 10 9/L, platelet count > or equal to 100 x 10 9/L, Hb > or equal 6 x10 9/L (it is allowed to give a blood transfusion if Hb is initially too low);
- •Adequate hepatic function (evaluated in the local lab): total bilirubin = 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase = 2.5 x ULN for the institution or <= 5 in case of liver metastasis;
- •Adequate renal function (evaluated in the local lab): creatinine clearance of at least 40 ml/min;
- •The patient is capable of complying with study procedures;
- •Life expectancy of at least 12 weeks;
- •Negative serum pregnancy test for females of childbearing potential.
- •Ability to comply with contraception requirements: Women of childbearing potential (WOCBP) must be using, from the screening to six months following the last study drug administration, effective contraception methods, as defined by the Recommendations for contraception and pregnancy testing in clinical trials issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html)
- •Signed and dated written informed consent;
- •2.Poly-metastatic disease (up to 10 metastasis)
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Histological confirmed limited metastatic adult NSCLC patients, regardless of the PD-L1 status.
- •oA minimum of 6 and maximum of 10 metastatic lesions, maximum two brain lesions are allowed
- •-SOC baseline imaging e.g. MRI and/or PET-CT and CT-brain or MRI brain and/or CT-scan with at least covering thorax-upper abdomen-brain within 6
- •weeks prior to randomisation.
- •-If a patient has unclear lesions in the liver or brain an MRI would be advised following the ESMO guidelines.
- •oControlled disease (i.e. no progressive disease according to RECIST 1.1) following primary platinum-based chemotherapy, wi
排除标准
- •For both groups; oligometastatic disease and Poly-metastatic disease
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •More than 10 metastatic lesions
- •Patients with pleuritis, pericarditis and peritonitis carcinomatosis
- •Patients who are already actively participating in another study.
- •SABR to more than one brain metastasis or whole brain radiotherapy (WBRT) is not allowed, although it is accepted when given at least 4 weeks prior to randomisation or after the treatment period. Patients with stable brain metastases are not excluded.
- •Previous radiotherapy to an area that would be re-treated by (SAB)R, resulting in overlap of the high dose areas;
- •Patients with progressive disease following first line or second line chemotherapy.
- •Other active malignancy or malignancy within the last 2 years (except localised skin basal/squamous cell carcinoma, non-muscle invasive carcinoma of the bladder or in situ carcinoma from any site);
- •Concomitantly administered glucocorticoids may decrease the activity of IL2 and therefore should be avoided. However, patients who develop life-threatening signs or symptoms may be treated with dexamethasone until toxicity resolves or reduces to an acceptable level.
- •History of allergy to intravenously administered proteins/peptides/antibodies/radiographic contrast media;
- •HIV positive; active HIV infection, or active hepatitis B or C (assessed in local lab).
- •oFor HBV serology: the determination of HBsAg, anti-HBsAg-Ab and anti-HBCAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV RNA indicating no current infection are eligible.
- •Systemic treatment with either corticosteroid (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to randomisation. Topical or inhalation steroids are allowed. If a patient needs to take unexpectedly immunosuppressive medication during the trial, it will be allowed but decreasing the dose as soon as possible is strongly advised.
- •Acute or sub-acute coronary syndromes within the last year, acute inflammatory heart disease, heart insufficiency NYHA > 2, or irreversible cardiac arrhythmias;
- •An impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % (or below the study site’s lower limit of normal) as measured by MUGA or ECHO. (LVEF measurements dating back up to 8 weeks from the screening will be acceptable in the absence of intercurrent use of potentially cardiotoxic treatment or cardiac medical history).
- •Uncontrolled hypertensive disease; (systolic BP (SBP) =160 or diastolic BP =100 mm Hg during two measurements)
- •History or evidence of active autoimmune disease;
- •Severe diabetic retinopathy (neoangiogenesis targeted by L19 outside the tumour)
- •Major trauma, including oncologic surgery, but excluding smaller procedures like the placement of porth-à-cath or surgical biopsy, within 4 weeks prio
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