Up to a fifth of people with advanced solid tumours have cancer in the brain and are usually barred from trials. Letting in those whose brain disease is treated, stable or symptom-free would widen trials and tell us whether drugs work in the brain.
Protocols would include patients with treated and stable brain metastases, and asymptomatic untreated metastases below a size threshold, with a pre-specified intracranial response assessment (RANO-BM) as a secondary endpoint. Exclusion would be allowed only for agents with a documented neurotoxicity signal or where the sponsor pre-registers a separate CNS cohort. The FDA brain metastases eligibility guidance supports this but uptake remains partial.
Shares Measure brain metastasis prevention as a primary endpoint, not as a secondary one, Lorlatinib, Tucatinib, The brain: barrier and sanctuary.
Shares Measure brain metastasis prevention as a primary endpoint, not as a secondary one, Tucatinib, The brain: barrier and sanctuary, Osimertinib.
Shares The brain: barrier and sanctuary, HER2-positive breast cancer, Melanoma, Non-small-cell lung cancer.
Shares The brain: barrier and sanctuary, HER2-positive breast cancer, Melanoma, Non-small-cell lung cancer.
Shares Tucatinib, The brain: barrier and sanctuary, Trastuzumab deruxtecan, HER2-positive breast cancer.
Shares Lorlatinib, Melanoma, Non-small-cell lung cancer.
Shares Tucatinib, Trastuzumab deruxtecan, HER2-positive breast cancer.
Shares Lorlatinib, Tucatinib, The brain: barrier and sanctuary, Osimertinib.