Actively Recruiting
Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer
Led by ETOP IBCSG Partners Foundation · Updated on 2026-04-27
180
Participants Needed
15
Research Sites
208 weeks
Total Duration
On this page
Sponsors
E
ETOP IBCSG Partners Foundation
Lead Sponsor
U
USZ Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, untreated (except surgery) asymptomatic or mildly symptomatic brain metastases
- Brain metastases confirmed by surgery or biopsy with MRI within 72 hours post-surgery
- 1 to 10 brain metastases, with at least one lesion 5 mm or larger
- Largest brain metastasis diameter 30 mm or less for 1-4 lesions
- Largest metastasis volume 10 mL or less and diameter 30 mm or less for 5-10 lesions
- Maximum total brain metastases volume 30 mL or less
- Histologically confirmed melanoma or NSCLC
- For melanoma: known BRAF status; prior immune checkpoint inhibitor allowed
- For NSCLC: newly diagnosed metastatic disease; known PD-L1 and driver mutation status
- Age 18 years or older
- Karnofsky performance status 60 or higher
- Life expectancy over 12 weeks
- Eligible for systemic therapy according to defined cohorts
- Negative pregnancy test for women of childbearing potential within 7 days before randomization
- Signed informed consent
You will not qualify if you...
- Confirmed or suspected leptomeningeal metastases
- Neurological symptoms needing more than stable 4 mg dexamethasone equivalent for over one week
- Not stable or off steroids at randomization
- Prior whole brain or focal brain radiation
- Prior systemic treatment for brain metastases
- Contraindication for stereotactic radiosurgery
- Investigator judgment of inability to comply with study requirements
- Pregnant or breastfeeding women
- Sexually active men or women of childbearing potential unwilling to use effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples, Italy
Actively Recruiting
2
Instituto Oncologico Veneto IRCCS
Padova, Italy
Not Yet Recruiting
3
Santa Maria della Misericordia Hospital
Perugia, Italy
Actively Recruiting
4
Istituto Nazionale Tumori "Regina Elena"
Roma, Italy
Actively Recruiting
5
Policlinico Umberto 1
Rome, Italy
Actively Recruiting
6
Azienda ospedaliero-universitaria Senese Siena
Siena, Italy
Actively Recruiting
7
NKI-AVL
Amsterdam, Netherlands
Actively Recruiting
8
Vall Hebron Institute of Oncology (VHIO)
Barcelona, Spain
Actively Recruiting
9
Hospital Puerta de Hierro
Majadahonda, Spain
Actively Recruiting
10
Hospital La Fe
Valencia, Spain
Actively Recruiting
11
Inselspital
Bern, Switzerland
Actively Recruiting
12
Kantonsspital Winterthur
Winterthur, Switzerland
Actively Recruiting
13
Universitätsspital Zürich
Zurich, Switzerland
Actively Recruiting
14
Royal Marsden (Sutton)
London, United Kingdom
Actively Recruiting
15
Christie NHS Manchester
Manchester, United Kingdom
Actively Recruiting
Research Team
H
Heidi Roschitzki-Voser, Dr.
CONTACT
S
Susanne Roux
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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