Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer

The primary objective of the study is to assess the efficacy in terms of CNS-specific PFS of the combination of standard systemic treatment plus SRS vs. standard systemic treatment alone in patients with newly diagnosed and untreated (except for surgery) asymptomatic or oligosymptomatic brain metastases from melanoma or NSCLC. This proposed randomised phase III clinical study addresses one of the most controversial issues in the current approach to patients with brain mets: the timing of SRS in patients eligible for systemic immune checkpoint inhibition or targeted therapy in order to guide therapeutic options as to what strategy allows the best compromise between best survival and best QoL.

NCT Number	NCT05522660
Lead Sponsor	ETOP IBCSG Partners Foundation Collaborators: USZ Foundation
Conditions	Non-Small Cell Lung Cancer, Melanoma
Enrollment	180 participants
Start Date	2022-11-30
Primary Completion	2026-09 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-27