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Table 2 Schedule of assessments

From: Thoracic radiotherapy plus Durvalumab in elderly and/or frail NSCLC stage III patients unfit for chemotherapy - employing optimized (hypofractionated) radiotherapy to foster durvalumab efficacy: study protocol of the TRADE-hypo trial

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   
  1. aCON-group radiation scheme: Patients receive conventional fractions of 30 × 2 Gy (60 Gy) within 6 weeks of TRT to be started within 72 h after start of durvalumab treatment
  2. bHYPO-group radiation scheme: Patients receive hypofractionated thoracic radiotherapy consisting of 20 × 2,75 Gy (55 Gy) within 4 weeks of TRT to be started within 72 h after start of durvalumab treatment
  3. cTo be performed on C2D1 and C3D1 if in accordance with local standard
  4. dChest X-ray to be performed on cycles 2 and 3 if in accordance with local standard
  5. eFirst on-study CT imaging to be performed 12 weeks after first durvalumab administration. Further on-study imaging to be performed Q8W (56 days ±7 days)
  6. fOnly applicable if EOT not according to already detected disease progression
  7. gIn patients with EOT not due to disease progression tumor imaging will be performed until the start of a new anticancer treatment, disease progression, death, withdrawal of consent, or the end of the study
  8. hQuestionnaires will be collected until disease progression only and may be collected by telephone calls
  9. iBiomarker sample to be taken prior to first study drug medication either during screening or C1D1 visit