The preparation and conducting of clinical research is a complicated, time consuming and labor intensive process, with many consecutive steps.
Maastro Trial office supports all these steps: from research idea to scientific publication.
The preparation and conducting of clinical research is a complicated, time consuming and labor intensive process, with many consecutive steps.
Maastro Trial office supports all these steps: from research idea to scientific publication.
It is a multicentre, randomised, controlled open-label phase II clinical trial testing the hypothesis that a combination of (SAB)R and immunocytokineL19-IL2 increases the progression-freesurvival in patients with limited metastatic NSCLC. After randomisation by minimization, patients will be assigned either to the experimental arm (E-arm) or tothe control arm(C-arm).
Patients continue the same immune therapy they already received and get radiotherapy to one lesion. The lesion may or may not be symptomatic, but it should be a lesion that increased in size, i.e. containing resistant cells, according to RECIST 1.1 criteria. The preferred radiotherapy dose is 24 Gy in 3 fractions (dosage on the 10 Gy isodose is allowed), but other fractionation schedules (e.g. 30 Gy/ 10 fractions, 20 Gy/ 5 fractions, 20-24 Gy / 1 fraction for SRS) are allowed if these are standard for a certain location or palliative indication in the body.