EUCTR2018-002583-11-IT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 - ImmunoSABR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- All
入选标准
- •1. Histological/Cytological confirmed limited metastatic adult NSCLC patients, regardless of the PD-L1 status.
- •2. Previous treatments
- •3. Patient received a (last gift) of live vaccine need to wait 8 weeks before they can be randomised and receive aPD(L)1 treatment.
- •4. Age of 18 years or older.
- •5. WHO performance status 0-1;
- •6. Adequate bone marrow function;
- •7. Adequate hepatic function and renal function;
- •8. Adequate endocrine function;
- •9. The patient is capable of complying with study procedures;
- •10. Life expectancy of at least 12 weeks;
- •11. Negative serum pregnancy test for females of childbearing potential;
- •12. Ability to comply with contraception requirements;
- •13. Signed and dated written informed consent;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •1. More than 10 metastatic lesions
- •2. More than 2 brain metastatic lesions
- •3. Two brain metastases with a cumulative diameter larger than 5 cm
- •4. Patients with non-infectious pneumonitis, uncontrolled thyroidbdisease, pleuritis, pericarditis and peritonitis carcinomatosis or other mild/serious infection at screening that might need antibiotic therapy.
- •5. Patients who received live vaccines 30 days or fewer prior to enrolment
- •6. Patients who are already actively participating in another interventional study with an investigational product.
- •7. Patients who need simultaneous radiation on the primary tumour and metastatic lesion(s).
- •8. Patients that need (maintenance) chemotherapy during ImmunoSABR
- •9. 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.
- •10. Previous radiotherapy to an area that would be re-treated by (SAB)R, resulting in overlap of the high dose areas;
- •11. Maintenance therapy with Anti-PD(L)1 treatment combined with chemotherapy is not allowed during treatment ((SAB)R and L19-IL2 cycles).
- •12. 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);
- •13. Concomitantly administered glucocorticoids may decrease the activity of IL2 and therefore should be avoided.
- •14. History of allergy to intravenously administered L19-IL2/proteins/peptides/antibodies/radiographic contrast media;
- •15. HIV positive; active HIV infection, or active hepatitis B or C (assessed in local lab).
- •16. Systemic treatment with either corticosteroid (>10 mg daily prednisone equivalents) or Interferon alpha or immunosuppressive medications within 14 days prior to randomisation. Topical or inhalation steroids are allowed.
- •17. Prior history of organ transplant, including autologous stem cell transplant.
- •18. Acute or sub-acute coronary syndromes within the last year, acute inflammatory heart disease, heart insufficiency NYHA > 2, or irreversible cardiac arrhythmias;
- •19. A known 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.
- •20. Uncontrolled hypertensive disease. Uncontrolled and symptomatic hypotensive disease.
- •21. History or evidence of active autoimmune disease;
- •22. Severe diabetic retinopathy (neoangiogenesis targeted by L19 outside the tumour)
- •23. Major trauma.
- •24. Any underlying mental, medical or psychiatric condition which in the opinion of the investigator will make administration of study drug hazardous or hinder the interpretation of study results
- •25. Unstable or serious concurrent uncontrolled medical conditions.
- •26. Pregnancy or breastfeeding
研究者
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