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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Relinde
Lieverse
+31 (0)43 3882334
immunosabr@maastrichtuniversity.nl
Mrs
N
Thieme
+31(0)43 3882334
immunosabr@maastrichtuniversity.nl
More information about this study, what is involved and how to take part can be found on the study website.
Advanced non-small cell lung cancer, stage IV
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The aim of this study is to verify whether immunotherapy (the study medication L19-IL2) after a standard treatment such as radiotherapy, is more effective than the current standard treatment alone in fighting advanced lung cancer, specifically non-small cell lung cancer that has spread beyond the lungs.
By giving the study medication L19-IL2 after the radiation therapy, a large number of the cancer cells will first be killed by radiation and then the immune system will give an additional boost which may improve control of the cancer. Unlike other anticancer treatments (such as chemotherapy) immunotherapy does not directly fight the cancer cells themselves. Immunotherapy stimulates the immune system, so that it can better recognise, attack and destroy the cancer cells. IL2 (Interleukin-2) is a signalling substance which activates immune cells directed against the tumour. In this way the immune system may become strong enough to fight the tumour. In order to take IL2 directly to the tumour sites, it is linked to a protein, L19 to form the study medication. This protein binds to newly formed blood vessels. Many types of cancer cause the development of newly-formed blood vessels to feed the tumour and allow it to grow. The protein L19 takes the signalling substance IL2 to the centre of the tumour where the immune cells will become activated.
In the past, the study medication L19-IL2 has been studied in patients with different types of cancer, both alone and in combination with chemotherapy. The medicine can be administered alone or in combination with chemotherapy and radiotherapy and does not cause unacceptable side effects in these combinations. Previous research on animals appears to show that the combination of radiation and the study medication L19-IL2 works much better than each of the treatments separately (radiation alone, or immunotherapy alone).
In this study, the outcomes of patients receiving standard care in a number of European hospitals will be compared to the outcomes of patients at the same hospitals receiving standard care followed by the study medication L19-IL2 as immunotherapy.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32539805/ protocol (added 17/06/2020)
You can take part if:
You may not be able to take part if:
1. ≥10 metastatic lesions2. ≥2 brain metastatic lesions3. 2 brain metastases with a cumulative diameter ≥5 cm4. Patients with non-infectious pneumonitis, uncontrolled thyroid disease, pleuritis, pericarditis and peritonitis carcinomatosis5. Received live vaccines ≤30 days prior to enrolment6. Already actively participating in another study7. 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 media14. 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 transplant17. Acute or sub-acute coronary syndromes within the last year, acute inflammatory heart disease, heart insufficiency NYHA >2, or irreversible cardiac arrhythmias18. 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 ECHO19. Uncontrolled hypertensive disease: systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mmHg during two measurements20. History or evidence of active autoimmune disease21. 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 conditions25. 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(L)1 treatment may increase the risk of immune-mediated disorders. Therefore, it will be contra-indicated for pregnant or lactating women.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Relinde
Lieverse
+31 (0)43 3882334
immunosabr@maastrichtuniversity.nl
Mrs
N
Thieme
+31(0)43 3882334
immunosabr@maastrichtuniversity.nl
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Maastricht University and funded by H2020-EU.3.1.3. - Treating and managing disease; H2020 European Research Council.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
