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

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 th

Trial Details

NCT ID
NCT05522660
Phase
PHASE3
Sponsor
ETOP IBCSG Partners Foundation
Status
RECRUITING
Cancer Type
BRAF Mutated Melanoma
Locations (sample)
  • Naples, Italy|40.85216,14.26811
  • Padova, Italy|44.38225,11.14261
  • Perugia, Italy|43.1122,12.38878
  • Roma, Italy|44.99364,11.10642
  • Rome, Italy|41.89193,12.51133

Key Eligibility Criteria

  • Newly diagnosed, previously untreated (except for surgery, see below) asymptomatic or oligo-symptomatic brain metastases, e.g., controlled symptoma…
  • 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 i…

For full eligibility, visit ClinicalTrials.gov.

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