Summary
This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.
Objectives
The study consists of a:
- Screening period (up to 28 days);
- Treatment period, during which participants will receive pumitamig or placebo in combination with chemotherapy (until disease progression, the occurrence of intolerable toxicity, withdrawal, death, or trial termination [whichever comes first]);
- Safety follow-up (FU) period (for up to 90 days after administration of the last dose of trial treatment) and survival follow-up (until the participant dies, withdraws consent for survival status follow-up, loss of contact, or sponsor decision, whichever occurs first).
Participants will be randomized 1:1 to receive either pumitamig in combination with the treatment of physician's choice (TPC) chemotherapy (Arm 1) or placebo in combination with TPC chemotherapy (Arm 2). Chemotherapy will be administered per standard of care. The randomization will be stratified based on the following factors:
- Prior treatment with cancer immunotherapy (yes versus no)
- On-trial chemotherapy regimen (paclitaxel/nab-paclitaxel versus gemcitabine plus carboplatin versus eribulin)
- Geography (East Asia versus the rest of the world [ROW])
- PD-L1 status (combine
Treatment Sites in Georgia
Piedmont Cancer Institute – Locust Grove
4877 Bill Gardner Pkwy
Locust Grove, GA 30248
Piedmont Cancer Institute – Sandy Springs
Piedmont Cancer Institute – Sandy Springs
755 Mount Vernon Hwy
Suite 320
Atlanta, GA 30328