OnCo
ideasIdea

Treat brain metastases as a disease with its own trials programme

A fifth of patients with solid tumours develop brain metastases and are usually excluded from trials. This would fund a programme that studies and treats them as a disease in their own right.

A funded network of brain-metastasis centres runs dedicated trials (systemic agents with CNS activity, radiosurgery sequencing, prevention in high-risk groups such as HER2-positive breast and EGFR/ALK lung cancer), builds a shared registry and tissue bank of resected metastases, and develops CNS-specific endpoints accepted by regulators. Funders and regulators would jointly discourage the routine exclusion of patients with stable brain metastases from registration trials.

Hypothesis
A dedicated programme raises the share of registration trials in lung, breast and melanoma that include patients with brain metastases from a minority to a majority within six years and produces at least two CNS-specific labels or guideline changes.
Rationale
Where brain metastases have been studied deliberately (tucatinib in HER2CLIMB, osimertinib CNS analyses, radiosurgery versus whole-brain trials) practice changed quickly; the constraint is that nobody funds the field systematically because it cuts across tumour-type programmes.
What would test it
Fund a five-centre pilot with a registry and two trials, and audit whether registration trials launched in the pilot's tumour types during the period relax their CNS exclusion criteria compared with the prior five years.
Maturity
speculative
Who has to act
research
Cost to try
Large (over $50M)
Years to first evidence
6
Bottlenecks it attacks

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