At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Stereotactic radiosurgery (radiation), Immune checkpoint inhibitor (drug)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- Stereotactic radiosurgery — radiation: Depending on the investigator's preference, the following standard of care fractionation schedules are recommended: 1x 18-22 Gy, 3x 9 Gy or 5x 6 Gy. · Immune checkpoint inhibitor — drug: Systemic therapy follows the current standard of care, according to the type of the primary tumour.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 180
- Started
- 2022-11-30
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase3 - 180 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • London - Royal Marsden (Sutton)
- • Manchester - Christie NHS Manchester
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ confirmed the diagnosis
- ✓ a negative urinary or serum pregnancy test within 7 days
What the study is looking for
- ✓Requirements for brain metastases:
- ✓Brain metastases must be previously untreated, except for surgery.
- ✓Number and size of metastases at diagnosis of brain metastases:
- ✓Maximum 1-10 brain metastases at screening
- ✓At least one brain metastasis must be of ≥5 mm in diameter
Who cannot take part
- ✗Confirmed or probable leptomeningeal metastases according to EANO ESMO criteria
- ✗causing symptoms brain metastases at time of randomisation, e.g., neurological symptoms or signs that require more than a...
- ✗Patients must be off steroids or on a stable dose of ≤4 mg dexamethasone equivalent at randomisation.
- ✗Patients experiencing seizures controlled by anti-epileptic drugs are eligible.
- ✗Prior whole brain irradiation or focal radiotherapy to the brain
See the full criteria
Where Is This Study? (2 UK sites)
Royal Marsden (Sutton)
London, United Kingdom
Christie NHS Manchester
Manchester, United Kingdom
How to Get in Touch
Heidi Roschitzki-Voser, Dr.
Sponsor contactCONTACT
Susanne Roux
Sponsor contactCONTACT
