- Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer — Recruiting • Phase III • Oncology • NCT05522660.
- Sponsor: ETOP IBCSG Partners Foundation.
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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…
- 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…
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