Eligibility
Both protocols require a histologically confirmed diagnosis of these types of cancer
What is Squamous and Non-Squamous NSCLC?
Efficacy assessments that should be performed before any other visit procedures
What are the PROs? (Patient Reported Outcomes / questionnaires)
The storage temperature of the investigational product
What is stored at 2 to 8°C?
These imaging criteria are used by the investigator and Blinded Independent Central Review (BICR) to determine response
What is RECIST v1.1?
If a urine dipstick shows proteinuria of ≥2+, this quantitative confirmatory assessment must be performed
What is a 24-hour quantitative urine protein analysis? (with ratio-based UPCR as the acceptable alternative)
It must be 0 or 1 for a participant to be eligible for in either study
What score of the ECOG PS is needed to be eligible?
Blood pressure must be measured after the participant has been resting quietly for at least this many minutes
What is 5 minutes?
Participants weighing ≥50 kg receive this dose of pumitamig
What is 1,500 mg?
The scanning procedure required for brain imaging (unless contraindicated)
What is an MRI?
The two frequency options for shipping samples to the central labs
What are: (1) Same‑day shipping for ambient samples and
(2)monthly shipping for frozen samples?
This type of tumor sample is not accepted for central lab submission
What is a cytologic tumor sample?
(S)AEs must be reported until this many days following treatment discontinuation or the last visit, whichever is latest
What is 90 days?
Pumitamig is administered as an IV infusion over this duration
What is 60 minutes?
The investigator must wait for this confirmation before discontinuing treatment
What is Blinded Independent Central Review (BICR) confirmation of progressive disease (PD)?
Screening laboratory assessments (hematology, chemistry, and urinalysis) are to be performed within this many days before randomization
What is 14 days?
These are the only antiplatelet or anticoagulant treatments allowed
What is prophylactic low-dose aspirin (≤100 mg/day) or clopidogrel (<75 mg/day)?
Type of search performed by Omnitrace for patient who fully withdrew consent
What is a survival status search?
A pumitamig dose adjustment is triggered when these criteria are met
What is a ≥10% change in body weight from baseline for 2 consecutive visits?
Partial Response (PR) and Complete Response (CR) must be confirmed at least this many days after the initial response
What is 28 days?
The timeframe under which screening labs can be carried forward to the first treatment visit (C1D1) without repeating
What is within 72 hours prior to randomization?
Both protocols exclude participants whose creatinine clearance level is below this measure. (Cockcroft-Gault formula)
What is 40 mL/min?
The Patient Reported Outcomes (PRO)/questionnaire to be completed before the other ones
What is NSCLC-SAQ?
Once the pumitamig infusion is prepared, these are the two permissible storage options and their maximum time limits
What are:
(1) room temperature for < 4 hours; and
(2) 2–8 °C for < 24 hours?
CT images must be acquired with a slice thickness of this measurement or less
What is 5 mm?
These 2 lab criteria trigger a potential drug-induced liver injury (DILI) SAE?
What are (1) ALT or AST >3× ULN, combined with
(2) total bilirubin >2× ULN? (no findings of cholestasis)