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

Table 2 Schedule of assessments

Procedure / Point in time	Screening	Treatment Cycles (Q4W)						EOT	Post-Treatment
Procedure / Point in time	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 (CON^a or HYPO^b)			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	X^e	Q8W^e	(X)^f		X^g
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

^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
^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
^cTo be performed on C2D1 and C3D1 if in accordance with local standard
^dChest X-ray to be performed on cycles 2 and 3 if in accordance with local standard
^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)
^fOnly applicable if EOT not according to already detected disease progression
^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
^hQuestionnaires will be collected until disease progression only and may be collected by telephone calls
ⁱBiomarker sample to be taken prior to first study drug medication either during screening or C1D1 visit

ISSN: 1471-2407