Here's an example of a trial with 30 patients that is focused on a diagnostic:
https://clinicaltrials.gov/ct2/show/NCT03820921?term=VENTANA MMR&draw=2&rank=1
Note that the primary endpoints for trial completion are 12-months (these are focused on the diagnostic). There is a secondary endpoint for tumour response at 3 months as well as overall survival and progression-free survival secondary outcomes at up to 12 months.
This to me might be the scale of trial that RAC may aim for, however more complicated since Melanoma trial for example will probably have 2 stratum (single agent and combination therapy).
Ann: Companion Diagnostic Study Initiated with UON, page-66
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