Long kanker progressive Lung cancer
Conditions
Interventions
blood sampling , stool sampling + translational research
Biopsy
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: • 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 not possible and/or without other findings suggestive for malignancy (i.e. no pericardial, pleural or peritoneal thickening) are eligible • History of immunotherapy related toxicity grade 3 or higher , except for controlled endocrine toxicity. • 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 m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of the trial is to test the activity of the combination of (SAB)R and L19-IL2 in patients with metastatic NSCLC will resulting in improved progression-free survival (PFS) compared to the SOC. | — |
Secondary
| Measure | Time frame |
|---|---|
| • PFS; • Overall survival; • Toxicity (CTCAEv4); • Quality of Life (EORTC QLQ C30 v3.0, QLQ LC13 and EQ5D); • The occurrence of OFRI / the abscopal effect using imaging, based on RECIST criteria; • The occurrence of an IFRI response, based on RECIST criteria. | — |
Countries
Netherlands
Outcome results
None listed