Procedure/Point in Time | Screening | Treatment | Follow-up | |||||
---|---|---|---|---|---|---|---|---|
Inclusion | Cycle 1 | Every further cycle (q2w) | End of treatment | Safety follow-up | Survival follow-up | |||
Day 1 | Day 8 | |||||||
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 | |||||
Radiotherapy | x | (x) | ||||||
Group B | Nivolumab | x | x |