Durvalumab in frail and elderly patients with stage four non-small cell lung cancer: Study protocol of the randomized phase II DURATION trial

Table 3 Schedule of assessments

						Arms B and C	All arms
Procedure/assessment	Screening 28d before C1D1	Treatment (q3w) ±2d				Maintenance (q4w) ±7d	End of treatment	Follow-Up ±7d
	Inclusion	C1 – C2 (Arm B/C) C1 - C4 (Arm A/D)		C3 (Arm B/C)	C4 (Arm B/C)	C5 – Cx
	Inclusion	Day 1	Day 8	C3 (Arm B/C)	C4 (Arm B/C)	C5 – Cx
Informed consent, eligibility criteria, demographics, medical and disease history	x
FFPE tumor tissue (PD-L1)	x
Vital signs, physical examination	x	x	x	x	x	x	x
ECOG	x			x		x	x	x^a
AE/SAE	x	x	x	x	x	x	x	x
CT/MRI of tumor lesions	x			x		x^b		x^c
HR-QoL	x			x		x^b	x	x
Charlson Comorbidity Index	x
CARG-score	x
Geriatric assessments	x					x	x	x^d
Biomarker sample		x^e		x	x^f	x^g	x	x^a
Treatments
Arm A		CHT	CHT	CHT	CHT
Arm B		CHT	CHT	Durvalumab	Durvalumab	Durvalumab
Arm C		CHT	CHT	Durvalumab	Durvalumab	Durvalumab
Arm D		CHT	CHT	CHT	CHT

^a At time of PD
^b Every other cycle (every 8 weeks)
^c During follow-up, CTs or MRIs will be performed every 8 weeks (±7 days) until confirmed disease progression or death in the context of standard care
^d At FU1 and time of PD
^e At baseline (C1D1)
^f Only arm B and C
^g After two cycles for durvalumab maintenance

ISSN: 1745-6215