Eligibility
What type of prior treatment must patients have completed to be eligible for this study?
Concurrent chemoradiation therapy (CCRT).
When must study treatment begin after randomization?
No later than 3 calendar days.
Are pumitamig vials intended for single-use or multi-use?
Single-use vials.
What imaging criteria are used by the investigator and Blinded Independent Central Review (BICR) to determine disease progression and response?
RECIST v1.1?
If a urine dipstick shows proteinuria of ≥2+, what confirmatory assessment should be performed?
24-hour quantitative urine protein analysis (with ratio-based UPCR as the acceptable alternative).
What ECOG Performance Status score is required to be eligible for this study?
0 or 1.
How many minutes should the participant quietly rest before blood pressure measurement?
At least 5 minutes.
What dose of pumitamig a participant weighing ≥50 kg will receive?
1,500 mg.
What type of imaging is required at screening?
-CT/MRI chest and abdomen
-FDG-PET-CT (whole body) .
What form must be used when shipping samples to Discovery Life Sciences (DLS)?
A paper requisition form.
If PD L1 testing is performed locally, where must that information be captured for this study?
1) EDC: In Microscopic Findings – Local PD L1
2) IRT: expression must also be captured in IRT for randomization/stratification.
For how many days following treatment discontinuation or the last visit should (S)AEs be reported?
90 days.
What is the primary vial strength used for pumitamig in this study, and what is used as backup?
500 mg vials (50 mg/mL) are primary.
Note: 200 mg vials (20 mg/mL) are used as backup.
Does central imaging review need to be completed before a subject can be randomized?
No—randomization is based on PI assessment; central review is not required.
What is a key requirement when preparing pathology reports or documentation before sending samples for central testing?
All documents must be de-identified before submission.
When can sites begin identifying potential patients for this study?
During concurrent chemoradiation (CCRT)—patients can be preidentified before completing treatment.
What is the required timeline to complete non-critical screening data in RAVE once status is known?
Within 5 days.
What specific condition must be met before a weight-based dose adjustment is implemented?
The weight change must be ≥10% from baseline and confirmed at two consecutive visits.
How many days after the initial response should Partial Response (PR) and Complete Response (CR) be confirmed?
28 days.
What is the timeframe under which screening labs can be carried forward to the first treatment visit (C1D1) without repeating?
Within 72 hours prior to randomization.
What level of creatinine clearance level excludes you from the study? (Cockcroft-Gault formula)
Less then 40 mL/min.
If unstained slides are submitted, what two requirements must they meet to be acceptable for submission?
(1) Slides must have been cut within 6 months from the FFPE tumor tissue block.
(2) Each slide must be 4–5 µm in section thickness
Once the pumitamig infusion is prepared, what are the two permissible storage options and their maximum time limits
(1) room temperature for < 4 hours; and
(2) 2–8 °C for < 24 hours
A scan shows possible disease progression, but the site submits it as routine imaging instead of selecting “PD suspected.” What is the impact?
Delayed progression confirmation as it will not be prioritized for expedited central review.
A site delays shipping a ctDNA sample overnight and stores it refrigerated until shipment. What protocol deviation(s) have occurred?
The sample was incorrectly handled.
1) ctDNA samples must be kept at ambient temperature (not refrigerated), and
2) they should be shipped the same day they are collected.