Eligibility
Which NSCLC histology are allowed in the study?
Squamous and Non-Squamous NSCLC
Which study procedure should be the first one to be performed at treatment visits?
Patient Reported Outcomes (PROs) / questionnaires
What is the storage temperature of the investigational product?
2 to 8°C
What is the allowed window for body and brain imaging at screening?
Within 28 days before randomization
Which lab should you ship screening tumor tissue slides to for PD-L1 testing at screening?
Discovery Life Science (DLS).
Remember to ship using the correct AWB and to utilize a paper requisition form only
Can local lab results be utilized to confirm eligibility for PD-L1 levels?
Yes, but only BMS pre-approved tests can be used. Remember to submit the survey and provide the required information for your VENTANA SP263, Agilent 22C3, and/or Agilent 28-8 tests.
True or False:
After disease progression and treatment discontinuation, the survival follow up visits are optional, survival status is nice to have but not mandatory.
FALSE.
Compliance to the safety follow up period is essential for the primary endpoint analysis. Please train your subjects and follow up until the OS event is observed.
How long should the Investigational Product IV infusion take?
60 minutes
What imaging procedure is required for brain imaging (unless contraindicated)?
MRI (Magnetic Resonance Imaging)
What are the two frequency for shipping samples to the central labs
(1) Same‑day shipping for ambient samples and
(2) Monthly shipping for frozen samples
What type of tumor sample is not accepted for central lab submission
Cytologic tumor samples / Fine Needle Aspirates
What are the study stratification factors?
(1) Histology (squamous vs. non-squamous)
(2) Brain metastases (Yes vs. No)
(3) Geographic region (Asia vs. Rest of World)
(1) and (2) are enter manually and cannot be corrected, be careful!
What are 2 requirements for patient unblinding?
1) medical emergency
2) treatment allocation is needed for patient management
(always contact the Medical Monitor before unblinding)
When the investigator assess progressive disease, what should he/she wait before discontinuing treatment?
Blinded Independent Central Review (BICR) confirmation of progressive disease (PD).
Remember to request for and expedited review!
Within how many days before randomization should Screening laboratory assessments be performed (hematology, chemistry, and urinalysis)?
Within 14 days
Can a patient with brain metastasis be enrolled?
Yes, but only if the metastasis have been definitively treated, are stable, do not require immediate re-treatment, and the participant has neurologically returned to baseline
What type of search should be requested to Omnitrace for participants who fully withdrew consent?
A survival status search.
Contact searches should be requested for Lost to Follow Up participants
For weight-related dose adjustments, which 3 requirements should be met?
1) 50kg threshold
2) >=10% change from baseline
3) at 2 consequent visits
What is the difference in the brain imaging schedule between patients with or without brain metastasis at screening?
With brain mets: brain MRI every 6 weeks (±7 days) for the first 48 weeks, then every 12 weeks (±7 days).
Without brain mets: brain MRI every 12 weeks (±7 days) starting from randomization.
What are the two conditions when safety labs should be repeated for re-screening?
1) if exclusionary
2) if out of window
What are the antiplatelet or anticoagulant treatments that are allowed in the study?
Low-dose aspirin (≤100 mg/day) and clopidogrel (<75 mg/day)
Which Patient Reported Outcomes (PRO) / questionnaire should be administered before the other PRO/questionnaires?
NSCLC-SAQ (Symptom Assessment Questionnaire)
How long should the patient stay under observation after the IV infusion?
Per local standard of care - refer to pembrolizumab local practice.
What is the max slice thickness for CT images acquisition?
5 mm
During a treatment visit, the patient has abnormal lab results: AST is >3× ULN and total bilirubin >2× ULN.
What should you do?
If there are no findings of cholestasis, report a potential drug-induced liver injury (DILI) SAE?