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. 2022 Sep 24;22:1011. doi: 10.1186/s12885-022-10074-9

Table 2.

Schedule of assessments

Procedure/ Point in Time Screening Treatment Post- Treatment
Inclusion C1D1 Each cycle (q2w ± 3 days) Every second cycle (q4w ± 3 days) EOT Safety FU-1* Safety FU-2** FU (q12w ± 14 days)
Central review – ILD exclusion# (x)
Informed consent, eligibility criteria, demographics, medical and disease history x
Prior and Concomitant Medication Review x x x x
Allocation/Randomization x
Vital Signs, O2 Saturation, and Weight x x x x x x
ECOG Performance Status x x x x
Pregnancy Test, CBC with Differential, Serum Chemistry Panel, Thyroid function test x x x x
Urinalysis x Whenever clinically indicated
12-lead ECG x Whenever clinically indicated
Pulmonary function tests x xa together with staging x x x
AEs x x x x x x x
Full Physical Examination x
Directed Physical Examination x x x x x
FACT-L questionnaire x x x x x x (x)
Tumor Imaging x (xb) (xc) (xd) (xd)
Tissue x Optional: Re-Biopsy at time of progression
Blood and stool x (xe) x x x
Atezolizumab administration x x
Radiotherapy (Arm Af) x

#: A sponsor-independent adjudication committee was established to exclude interstitial lung disease (ILD) [Excl. criterion 5] in all pre-screened patients prior to study inclusion. All study sites are encouraged to provide tumor imaging in pseudonymize form during the (pre-)screening phase for the central review process

*: The regular 30-day full safety follow-up period (FU-1) begins on the day after the EOT visit and lasts approximately 30 days. The FU-1 visit occurs at or near the end of the 30-day safety follow-up period (±7 days)

**: The regular 90-day full safety follow-up period (FU-2) begins on the day after the EOT visit and lasts approximately 90 days. The FU-2 visit occurs at or near the end of the 90-day safety follow-up period (±7 days)

a: To be performed on C1D1 if in accordance with local standard

b: Chest X-ray to be performed on cycle 1 if in accordance with local standard

c: First on-study imaging to be performed 6 weeks (± 7 days) after baseline imaging. Further on-study imaging to be performed Q6W (42 days ±7 days) for the first 36 weeks, and every 9 weeks (±7 days) thereafter until occurrence of disease progression, according to the standard of care

d: Only applicable if EOT not according to already detected disease progression

e: Biomarker sample to be taken prior to first study drug medication or before first administration of thoracic radiotherapy for arm A, either during screening or C1D1 visit

f: Patients in arm A receive thoracic radiotherapy with a dose fractionation of 10 × 3 Gy (30 Gy) within 2 weeks (+ 7 days) in combination with atezolizumab treatment. Thoracic radiotherapy to be started within 7 weeks after C4D1 of induction therapy