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Looking for participantsPhase3

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

Sponsor: ETOP IBCSG Partners Foundation

NCT ID: NCT05522660

View on ClinicalTrials.gov ↗

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.

Non-Small Cell Lung CancerMelanoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

BRAFPD-L1have a negative

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
Most important inclusion criteria: * Newly diagnosed, previously untreated (except for surgery, see below) asymptomatic or oligo-symptomatic brain metastases, e.g., controlled symptomatic seizure disorder. Note: patients with neurological symptoms or signs that require more than a stable dose of 4 mg dexamethasone equivalent for more than one week are not considered oligo-symptomatic. * Requirements for brain metastases: * Brain metastases must be previously untreated, except for surgery. * Prior surgery (including biopsies, resection, and cyst aspiration) for brain metastases is allowed. Residual and measurable disease after surgery is not required, but surgery must have confirmed the diagnosis. An MRI performed within 72 hours post-surgery should be available. * 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 * In case of 1-4 brain metastases: * Longest diameter of largest brain metastasis must be ≤30 mm * In case of 5-10 brain metastases: * Largest metastasis must be ≤10 mL in volume and longest diameter must be ≤30 mm * Maximum cumulative brain metastases volume must be ≤30 mL * Primary disease of histologically confirmed (from primary tumour or from a metastatic lesion, including in the brain) melanoma or NSCLC * Requirements for patients with melanoma: * Prior treatment, including treatment with immune-checkpoint inhibitors is permitted, but brain metastases must be newly diagnosed and previously untreated (except for surgery). * BRAF-mutation status, locally assessed, should be known (previous adjuvant BRAF-targeted therapy is allowed). * Requirements for patients with NSCLC: * Newly diagnosed, treatment-naïve (except for prior surgery) metastatic NSCLC, with or without a targetable oncogenic driver alteration. * Known PD-L1 expression status (from primary tumour or from a metastatic lesion, including brain) * Known driver mutation status (from primary tumour or from a metastatic lesion, including brain). * Age of 18 years or older * Karnofsky performance status of 60 or more * Life expectancy \>12 weeks * Patients must be candidates for systemic treatment, within the defined cohorts (melanoma: cohorts 1a and 1b; NSCLC: cohorts 2a and 2b). * Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 7 days before randomisation. * Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention. Most important exclusion criteria: * Confirmed or probable leptomeningeal metastases according to EANO ESMO criteria * Symptomatic brain metastases at time of randomisation, e.g., neurological symptoms or signs that require more than a stable dose of 4 mg dexamethasone equivalent for more than one week. * 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 radiation therapy to the brain * Prior systemic treatment for brain metastases * Contra-indication for SRS * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. * Women who are pregnant or in the period of lactation. * Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.

Where Is This Study? (2 UK sites)

Royal Marsden (Sutton)

London, United Kingdom

Recruiting
Site contact (verified)

Christie NHS Manchester

Manchester, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Heidi Roschitzki-Voser, Dr.

Sponsor contact

CONTACT

+41 31 511 94 18 heidi.roschitzki@etop.ibcsg.org

Susanne Roux

Sponsor contact

CONTACT

+41 31 511 94 17 susanne.roux@etop.ibcsg.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-04