OncoMatch/Clinical Trials/NCT05522660
Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer
Is NCT05522660 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Immune checkpoint inhibitor for non-small cell lung cancer.
Treatment: Immune checkpoint inhibitor — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Melanoma
Biomarker criteria
Required: BRAF mutation
BRAF-mutation status, locally assessed, should be known (previous adjuvant BRAF-targeted therapy is allowed)
Required: PD-L1 (CD274) expression (known)
Known PD-L1 expression status (from primary tumour or from a metastatic lesion, including brain)
Disease stage
Metastatic disease required
Newly diagnosed, previously untreated (except for surgery) asymptomatic or oligo-symptomatic brain metastases
Prior therapy
Cannot have received: whole brain irradiation
Prior whole brain irradiation or focal radiation therapy to the brain
Cannot have received: focal radiation therapy
Prior whole brain irradiation or focal radiation therapy to the brain
Cannot have received: systemic treatment for brain metastases
Prior systemic treatment for brain metastases
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05522660 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require BRAF?
Yes, BRAF mutation is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify