Table 3.

Operating Characteristics for Generic Trial Design in FOCUS4-D: All Wild-Type Cohort

	Phase II		Phase III
Characteristic	Stage 1: Safety and LSA	Stage 2: LSA	Stage 3: Efficacy for PFS	Stage 4: Efficacy for OS (potential)
Outcome	PFS	PFS	PFS	OS
One-sided α	0.30	0.10	0.025	0.025
Power (overall power maintained at 80%)	0.95	0.95	0.95	0.85
Target HR	0.65	0.65	0.65	0.70
Critical HR	0.91	0.83	0.79	0.80
Time required, months	20	11	12	19
Cumulative time, months	20	31	42	61
Cumulative events required
Control arm	41	72	107	109
Total	109	198	301	289
Total expected cumulative random assignments	180	275	381	547

Abbreviations: HR, hazard ratio; LSA, lack of sufficient activity; OS, overall survival; PFS, progression-free survival.