# Treat brain metastases as a disease with its own trials programme

Source: https://onco.cc/ideas/idea-fund-brain-metastases-programme/  
OnCo record `idea-fund-brain-metastases-programme` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed test: 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
- Actor: research

## Sources

- Bottleneck evidence (Funding follows fashion, not burden): Carter & Nguyen, A comparison of cancer burden and research spending (BMC Cancer 2012): https://doi.org/10.1186/1471-2407-12-526

## Connected records

- ideas: [A ring-fenced metastasis programme with metastasis-specific endpoints](https://onco.cc/ideas/idea-fund-metastasis-moonshot/), [Measure brain metastasis prevention as a primary endpoint, not as a secondary one](https://onco.cc/ideas/idea-lung-brain-metastasis-prevention-as-a-primary-endpoint/)
- cancers: [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [Melanoma](https://onco.cc/cancers/melanoma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [SBRT / SABR (stereotactic radiotherapy)](https://onco.cc/technologies/sbrt/), [Whole-body MRI](https://onco.cc/technologies/whole-body-mri/)
- drugs: [Osimertinib](https://onco.cc/drugs/osimertinib/), [Tucatinib](https://onco.cc/drugs/tucatinib/)
- bottlenecks: [Funding follows fashion, not burden](https://onco.cc/bottlenecks/b-funding-allocation/), [The brain: barrier and sanctuary](https://onco.cc/bottlenecks/b-brain-delivery/)
- key papers: [Benefits of hyperthermic intraperitoneal chemotherapy for patients with serosal invasion in gastric cancer: a meta-analysis of the randomized controlled trials](https://onco.cc/key-papers/paper-sun-bmc-cancer/), [FLAURA: osimertinib as first treatment for EGFR-mutated lung cancer](https://onco.cc/key-papers/paper-flaura-nejm-2018/), [Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer](https://onco.cc/key-papers/paper-osimertinib-nsclc-n-engl-j-med-2017/), [Overall Survival with Osimertinib in Untreated, EGFR -Mutated Advanced NSCLC](https://onco.cc/key-papers/paper-osimertinib-nsclc-n-engl-j-med-2020/)

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