patients with asymptomatic active brain metastases from small cell lung cancer
Conditions
Brief summary
- BM ORR (RANO-BM). This will be evaluated with MRI brain after six weeks of treatment and there-after every six weeks. Confirmed BM ORR according to RANO-BM will be measured at 12 weeks.
Detailed description
All imaging related endpoints will be measured with MRI brain for BM related outcomes and CT chest and upper abdomen for extracranial related outcomes after six weeks of treatment and thereafter eve-ry six weeks. - Key secondary: BM DCR (RANO-BM), CNS PFS (RANO-BM) - Extracranial ORR and DCR (RECIST 1.1) - extracranial PFS (based on RECIST 1.1) - overall PFS (based on RANO-BM for BM and RECIST 1.1 for extracranial lesions) - OS - Safety according to CTCAE v 5.0 during every visit
Interventions
DRUGTarlatamab
Sponsors
Academisch Ziekenhuis Maastricht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - BM ORR (RANO-BM). This will be evaluated with MRI brain after six weeks of treatment and there-after every six weeks. Confirmed BM ORR according to RANO-BM will be measured at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| All imaging related endpoints will be measured with MRI brain for BM related outcomes and CT chest and upper abdomen for extracranial related outcomes after six weeks of treatment and thereafter eve-ry six weeks. - Key secondary: BM DCR (RANO-BM), CNS PFS (RANO-BM) - Extracranial ORR and DCR (RECIST 1.1) - extracranial PFS (based on RECIST 1.1) - overall PFS (based on RANO-BM for BM and RECIST 1.1 for extracranial lesions) - OS - Safety according to CTCAE v 5.0 during every visit | — |
Outcome results
None listed