EORTC-2456-LCG-BTG: A randomized phase II study evaluating upfront SRT to all brain metastases followed by ivonescimab plus chemotherapy versus upfront ivonescimab plus chemotherapy in patients with asymptomatic active brain metastases from NSCLC.

Condition studied

Non-small cell lung cancer

Investigational medicinal product(s)

Every trial of Ivonescimab, Paclitaxel and Carboplatin across our registers →

Eligibility

Primary endpoint

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.

Endpoint detail

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.