Procedure / Point in time | Screening | Treatment Cycles (Q4W) | EOT | Post-Treatment | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Screening | C1D1 | C1D4 | C2D1 | C3D1 | C4D1 | C5D1-C13D1 | EOT | Safety FU | FU (Q12W) | |
Informed Consent, eligibility criteria, demographics, medical and history | X | |||||||||
Allocation/ Randomization | X | |||||||||
Prior and Concomitant Medication Review | X | X | X | X | X | X | ||||
Durvalumab administration | X | X | X | X | X | |||||
Radiotherapy (CONa or HYPOb) | X | |||||||||
AEs | X | X | X | X | X | X | X | X | X | |
Full Physical Examination | X | X | ||||||||
Directed Physical Examination | X | X | X | X | X | X | ||||
Vital Signs, O2 Saturation, and Weight | X | X | X | X | X | X | X | X | ||
Pulmonary function tests | X | (X)c | (X) c | together with staging | X | X | ||||
12-lead ECG | X | Whenever clinically indicated | ||||||||
ECOG Performance Status | X | X | X | X | X | X | ||||
Pregnancy Test, CBC with Differential, Serum Chemistry Panel, Thyroid function test | X | X | X | X | X | X | X | |||
HBV/ HCV | X | |||||||||
Urinanalysis | X | Whenever clinically indicated | ||||||||
Tumor Imaging | X | (X)d | (X)d | Xe | Q8We | (X)f | Xg | |||
FACT-L and G8 screening questionnaire | X | X | X | X | together with staging | X | X | (X)h | ||
Tissue | X | Optional: Re-Biopsy at time of progression | ||||||||
Blood and stool | Xi | Xi | X | X | X |