ISRCTN49817477进行中（未招募）2 期
Multicentre, randomised, 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
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 88
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32539805/ protocol (added 17/06/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Oligometastatic disease participants:
- •1. Histological/cytological confirmed limited metastatic adult NSCLC patients, regardless of the PD-L1 status
- •2. =5 metastatic lesions and =2 brain lesions with a total cumulative diameter of 5 cm
- •3. In 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. Whether the patient has an M1 disease or not will be at the discretion of the local multidisciplinary tumour board.
- •4. Prior cancer treatments must have been discontinued for =4 weeks before randomisation. In case of maintenance chemotherapy, this therapy will only be started after the end of the L19-IL2 treatment or only in case of Anti-PD(L)1 treatment, during L19-IL2 therapy.
- •Poly-metastatic disease participants:
- •1. Histological/cytological confirmed limited metastatic adult NSCLC patients, regardless of the PD-L1 status
- •2. Between 6 and 10 metastatic lesions, inclusive, and =2 brain lesion with a total cumulative diameter of 5cm
- •3. Last administration of chemo and/or immunotherapy (given as a first or second-line standard of care treatment) =4 weeks before randomisation. In case of maintenance chemotherapy, this therapy will only be started after the end of the L19-IL2 treatment or only in case of Anti-PD(L)1 treatment, during L19-IL2 therapy.
- •All participants:
- •1. Aged =18 years
- •2. WHO performance status 0-1
- •3. Adequate bone marrow function, evaluated in the local laboratory (Lab): Absolute Neutrophil Count (ANC) of =1.0 x 109 /l, platelet count =100 x 109 /l, Haemoglobin (Hb) =6.0 mmol/l (or 9.67 g/dl) (it is allowed to give a blood transfusion if Hb is initially too low)
- •4. 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)
- •5. Adequate renal function (evaluated in the local lab): creatinine clearance of =40 ml/min
- •5. Capable of complying with study procedures
- •6. Life expectancy of =12 weeks
- •7. Negative serum pregnancy test for females of childbearing potential.
- •8. Ability to comply with contraception requirements:
- •8.1. 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 medication, during the study and at least up to 12 weeks after the last administration of the study medicine and up to 5 months after the last dose of the medicine with anti-PDL)1 as an action mechanism (if you get this product besides the study medicine)
- •8.2. Women of childbearing potential (WOCBP) and WOCBP partners of male patients must be using, from the screening to three months following the last study drug administration and 5 months after last dose of anti-PD(L)1 maintenance treatment, 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):
- •8.2.1. IUD (IUD) or intrauterine hormone delivery system (IUS)
- •8.2.2. Combined (with estrogen and progesterone) hormonal contraception associated with ovulation inhibition (oral, intravaginal, transdermal)
- •8.2.3. Hormonal contraception with progesterone-only associated with ovulation inhibition (oral, injectable, implantable)
排除标准
- •1. =10 metastatic lesions
- •2. =2 brain metastatic lesions
- •3. 2 brain metastases with a cumulative diameter =5 cm
- •4. Patients with non-infectious pneumonitis, uncontrolled thyroid disease, pleuritis, pericarditis and peritonitis carcinomatosis
- •5. Received live vaccines =30 days prior to enrolment
- •6. Already actively participating in another study
- •7. Requiring simultaneous radiation on the primary tumour and metastatic lesion(s). For these patients, it might be an option to treat the primary tumour first, although this is not mandatory for this study.
- •8. Whole-brain radiotherapy (WBRT) is not allowed, although it is accepted when given at =4 weeks prior to randomisation or after the treatment period. Patients with stable brain metastases are not excluded.
- •9. Previous radiotherapy to an area that would be re-treated by (SAB)R, resulting in overlap of the high dose areas.
- •10. Maintenance therapy with Anti-PD(L)1 treatment combined with chemotherapy during treatment ((SAB)R and L19-IL2 cycles)
- •11. 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)
- •12. Concomitantly administered glucocorticoids (these 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 (generally grade 1 and 2, however, must be based at the research physician’s discretion).
- •13. History of allergy to intravenously administered proteins/peptides/antibodies/ radiographic contrast media
- •14. HIV positive, active HIV infection, or active hepatitis B or C (assessed in local lab)
- •15. Systemic treatment with either corticosteroid (>10 mg daily prednisone equivalents) or Interferon alpha or immunosuppressive medications =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.
- •16. Prior history of organ transplant, including autologous stem cell transplant
- •17. Acute or sub-acute coronary syndromes within the last year, acute inflammatory heart disease, heart insufficiency NYHA >2, or irreversible cardiac arrhythmias
- •18. 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
- •19. Uncontrolled hypertensive disease: systolic blood pressure (SBP) =160 or diastolic blood pressure (DBP) =100 mmHg during two measurements
- •20. History or evidence of active autoimmune disease
- •21. Severe diabetic retinopathy (neoangiogenesis targeted by L19 outside the tumour)
- •22. Major trauma, including oncologic surgery, but excluding smaller procedures like the placement of porth-à-cath or surgical biopsy, =4 weeks prior to randomisation (neoangiogenesis targeted by L19 outside a tumour)
- •23. 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
- •24. Unstable or serious concurrent uncontrolled medical conditions
- •25. Pregnancy or breastfeeding. It is well known that ED-B, the target of both L19IL2, is expressed in a variety of foetal tissues. Furthermore, anti-PD(
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