Fostering efficacy of anti-PD-1-treatment: Nivolumab plus radiotherapy in advanced non-small cell lung cancer - study protocol of the FORCE trial

Table 2 Schedule of assessments

Procedure/Point in Time		Screening	Treatment				Follow-up
		Inclusion	Cycle 1		Every further cycle (q2w)	End of treatment	Safety follow-up	Survival follow-up
		Inclusion	Day 1	Day 8	Every further cycle (q2w)	End of treatment	Safety follow-up	Survival follow-up
Informed consent, eligibility criteria, demographics, medical and disease history		x
FFPE tumor tissue (PD-L1)		x
Vital signs, physical examination, ECOG		x	x	x	x	x	x
Hematology, serum chemistry, liver function tests		x	x	x	x	x	x
HBV, HCV		x
Thyroid function test		x	x		x ^a	x	x
Pregnancy test		x			x ^a
AEs/SAEs		x	continuously				x
Concomitant medication		x	continuously				x	x
QoL		x	x		x ^b	x	x	x
Biomarker sample		x		x	x	x
Radiographic tumor assessments		x			x ^a		x	x
Survival information, subsequent therapies								x
Group A	Nivolumab		x		x
Group A	Radiotherapy		x	(x)
Group B	Nivolumab		x		x

ISSN: 1471-2407