Non-small cell lung cancer
Conditions
Brief summary
The primary endpoint is intracranial progression-free survival per RANO-BM criteria based on local assessment. It is defined as the time interval between the date of randomization and the date of intracranial progression or death, whichever occurs first.
Detailed description
Intracranial progression-free survival according to RANO-BM criteria based on retrospective central review, Time to next CNS intervention (TNCI), Overall Survival (OS), Intracranial overall response rate (icORR) based on RANO-BM criteria as per local assessment (in the upfront systemic therapy arm), The occurrence of any grade and grade ≥ 3 adverse events according to CTCAE v5.0, Cerebral (symptomatic) radio necrosis rate (in patients receiving SRS/FSRT during the course of treatment)., Duration of intracranial response as per local assessment.
Interventions
DRUGCarboplatin 10 mg/ml Concentrate for Solution for Infusion
DRUGivonescimab
DRUGNaveruclif 5 mg/ml powder for dispersion for infusion
Sponsors
European Organisation For Research And Treatment Of Cancer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is intracranial progression-free survival per RANO-BM criteria based on local assessment. It is defined as the time interval between the date of randomization and the date of intracranial progression or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial progression-free survival according to RANO-BM criteria based on retrospective central review, Time to next CNS intervention (TNCI), Overall Survival (OS), Intracranial overall response rate (icORR) based on RANO-BM criteria as per local assessment (in the upfront systemic therapy arm), The occurrence of any grade and grade ≥ 3 adverse events according to CTCAE v5.0, Cerebral (symptomatic) radio necrosis rate (in patients receiving SRS/FSRT during the course of treatment)., Duration of intracranial response as per local assessment. | — |
Outcome results
None listed