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