Skip to main content

Table 3 Schedule of assessments

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

   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
Day 1 Day 8
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 xa
AE/SAE x x x x x x x x
CT/MRI of tumor lesions x    x   xb   xc
HR-QoL x    x   xb x x
Charlson Comorbidity Index x        
CARG-score x        
Geriatric assessments x      x x xd
Biomarker sample   xe   x xf xg x xa
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    
  1. a At time of PD
  2. b Every other cycle (every 8 weeks)
  3. 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
  4. d At FU1 and time of PD
  5. e At baseline (C1D1)
  6. f Only arm B and C
  7. g After two cycles for durvalumab maintenance