If repeat scans confirm there is defini tely a new lesion, then progression should be declar ed using the date of the init ial scan. 2.3 Response Assessment 2.3.1 Evaluation of Best Overall Response The best overall response is the best response r ecorded from the start of the study treatment until disease progression per PCWG3 crit eria, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy. The patient’s best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Furthermore, depending on the nature of the study and the protocol requirements , it may also require confirmatory measurement. 2.3.2 Time Point Response At each protocol specified time point, a response assessment occurs. Table 2.3.2-1 provides a summary of the overall response status calculation at each time point for patients who have measurable disease at baseline. When patients have non-measurable (therefore non-target) disease only, Table 2.3.2-2 is to be used. Table 2.3.2-1: Time Point Response: Patients With Target (± Non-Target) Disease Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR Non-CR/non-PD No PR CR Not evaluated No PR PRNon-PD or not all evaluatedNo PR SDNon-PD or not all evaluatedNo SD Not all evaluated Non-PD No NE PD Any Yes or No PD Any PD Yes or No PD Any Any Yes PD CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease and NE = inevaluable Revised Protocol No.: 04 Date: 31-May-2019 226 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS Table 2.3.2-2: Time Point Response: Patients with Non-target Disease Only Non-Target Lesions New Lesions Overall Response CR No CR Non-CR/non-PD No Non-CR/non-PDa Not all evaluated No NE Unequivocal PD Yes or No PD Any Yes PD CR = complete response, PD = progressive disease and NE = inevaluable aNon-CR/non-PD is preferred over SD for non-target disease since SD is increasingly used as en dpoint for assessment of efficacy in some trials so to assign this category when no lesions can be measured is not advised. 2.3.3 Best Overall Response Best response determin ation of complete or par tial res ponse requires confirmation: Complete or partial responses may be claimed only if the criteria for each are met at a subsequent time point of ≥4 weeks (28 days) later.