International Phase III Trial of a Novel Approach to NSCLC Brain Metastases

Challenge

A global Phase III trial compared a novel approach to treating non-small cell lung cancer brain metastases against standard of care. The trial's efficacy conclusions depended on both intracranial control and systemic disease status, which meant brain MRI and body CT had to be reviewed under different criteria by different subspecialists while producing a single coherent assessment per patient per visit.

Over a multi-year duration with several thousand radiological reads, the sponsor needed consistent intracranial measurement despite heterogeneous MRI protocols, reliable differentiation of treatment effect from progression, and a workflow that kept the neuroradiology and oncology assessments synchronized so that progression events were dated consistently across compartments.

Intrinsic Imaging’s Solution

Intrinsic Imaging designed an imaging charter covering both compartments, with standardized post-contrast brain MRI parameters and body CT requirements, and qualified every site against both. Site training emphasized timepoint alignment so that brain and body imaging were acquired within the same window.

The company's nine full-time neuroradiologists reviewed intracranial disease and its ten-radiologist oncology team reviewed extracranial disease, each under blinded independent double reads with adjudication. Reading workflows were linked so that the overall response and progression date for each visit were derived from both assessments under rules defined in the charter.

Quality control, image transfer and data management were centralized, and project managers tracked read volumes across the multi-year program, scaling reader assignments ahead of enrollment peaks.

Intrinsic Imaging’s Results

• Approximately 5,400 reads completed by coordinated neuroradiology and oncology teams across 72 sites in 13 countries
• Intracranial and extracranial assessments synchronized to a single per-visit response record with consistent progression dating
• Standardized brain MRI protocol adopted at all sites, with unevaluable intracranial timepoints below 3%
• Reader agreement on intracranial progression above 90% at each monitoring interval over the multi-year trial