Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer
- Conditions
- ong kankerprogressive Lung cancer
- Registration Number
- NL-OMON56015
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 56
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).
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main objective of the trial is to test the activity of the combination of<br /><br>(SAB)R and L19-IL2 in patients with metastatic NSCLC will resulting in improved<br /><br>progression-free survival (PFS) compared to the SOC.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• PFS;<br /><br>• Overall survival;<br /><br>• Toxicity (CTCAEv4);<br /><br>• Quality of Life (EORTC QLQ C30 v3.0, QLQ LC13 and EQ5D);<br /><br>• The occurrence of OFRI / the abscopal effect using imaging, based on RECIST<br /><br>criteria;<br /><br>• The occurrence of an IFRI response, based on RECIST criteria.</p><br>