In the Lancet publication, in the section on Timepoint and best overall response it is stated that
“The protocol should establish how missing response assessments will be handled. Assessments that are not done or are not evaluable should be disregarded. For example, an iUPD followed by an assessment that was not done or not evaluable, and then another unconfirmed progressive disease, would be indicative of iCPD.”
Does this mean that the if there is a missing evaluation the NEXT assessment confirms iCPD even if no change had occurred?
Answer: The requirements of ICPD must still be met as detailed in the publication (for example, a further new lesion, an increase in iSOM (target new lesions) by at least 5mm, increase in size of non-target-new lesions, or new RECIST 1.1 PD in other categories