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

 

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
Sponsor: ETOP IBCSG Partners Foundation
Coordinating Group: ETOP IBCSG Partners Foundation
Participating Countries:   

Italy, the Netherlands, Switzerland, and United Kingdom

Registrations: NCT05522660


Contact

Julien Org├╝l (Clinical Trial Manager)

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ETOP IBCSG Partners Foundation

Effingerstrasse 33

3008 Bern, Switzerland