The trial will consist of one cohort of adult patients with Stage IV metastatic NSCLC

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 126

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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