A multicentre randomised open-label phase III study of stereotactic radiosurgery, in addition to standard systemic therapy for patients with metastatic melanoma or newly diagnosed metastatic NSCLC and asymptomatic or oligo-symptomatic brain metastases.

USZ-STRIKE: Immunotherapy or targeted therapy with or without stereotactic radiosurgery for patients with brain metastases from melanoma or non-small cell lung cancer

The trial aims to assess the efficacy of standard systemic treatment plus stereotactic radiosurgery in patients with newly diagnosed brain metastases from melanoma or NSCLC. 

Trial Scheme

USZ STRIKE trial schema

Trial Information

Primary Endpoint:
CNS-specific PFS, locally assessed as per iRANO criteria
Secondary Endpoints:
CNS-specific PFS per tumour cohort, locally assessed as per iRANO criteria
CNS-specific PFS, overall and per tumour cohort, centrally assessed as per iRANO criteria
Objective CNS-response rate, centrally assessed as per iRANO criteria
Duration of CNS-response
Pattern of CNS-specific progression (local versus distant progression)
Extra-CNS progression, locally assessed as per RECIST v1.1
Incidence of radio-necrosis and pseudo-progression in the CNS
OS, overall and per tumour cohort
Neurocognitive function
Quality of life and functional independence
Toxicity by CTCAE v5
Target Sample Size:
190 randomised patients
Protocol Release Date:
14 February 2022

Trial Organisation

Trial Chair:
Michael Weller
Trial Co-Chairs:
Rolf Stahel
ETOP IBCSG Partners Foundation
Coordinating Group:
ETOP IBCSG Partners Foundation
Participating Countries: 
Italy, the Netherlands, Switzerland, United Kingdom


ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland

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