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Table 2 Schedule of assessments

From: Protocol of the TREASURE study: Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease – a randomized, open-label, multicenter phase II trial

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

      
  1. #: 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
  2. *: 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)
  3. **: 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)
  4. a: To be performed on C1D1 if in accordance with local standard
  5. b: Chest X-ray to be performed on cycle 1 if in accordance with local standard
  6. 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
  7. d: Only applicable if EOT not according to already detected disease progression
  8. 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
  9. 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
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BMC Cancer

ISSN: 1471-2407

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