This is a multicenter, randomized, open-label, international, Phase 3 trial to evaluate
the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel
(standard of care) in participants with locally advanced (unresectable stage IIIB/C) or
programmed death ligand 1 (PD-L1)-positive metastatic non-small cell lung cancer (NSCLC)
who have been treated with programmed cell death protein 1 (PD-1)/PD-L1 inhibitor and
platinum-containing chemotherapy, administered either in combination or sequentially in
the locally advanced (unresectable stage IIIB/C) or metastatic setting.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06635824.
Locations matching your search criteria
United States
California
Los Angeles
USC / Norris Comprehensive Cancer CenterStatus: Active
Contact: Sandy Tran
Phone: 323-865-3935
Newport Beach
USC Norris Oncology/Hematology-Newport BeachStatus: Active
Contact: Sandy Tran
Phone: 323-865-3935
The goal of this trial is to determine the efficacy and safety of acasunlimab (an
experimental antibody also known as GEN1046 or DuoBody® PDL1x4-1BB) in combination with
pembrolizumab (an antibody known as KEYTRUDA®) compared to that of docetaxel (a standard
of care chemotherapy). During the trial, the participant's quality of life will also be
evaluated using industry-standard scales of measurement. To be eligible, participants
must have:
1. non-small cell lung cancer that are locally advanced, unresectable stage IIIB/C or
has metastasized (spread)
2. tumors that are positive for the PD-L1 protein (a biomarker that may be predictive
of response to therapy)
3. been previously treated with a PD-1/PD-L1-inhibitor and a platinum-containing cancer
therapy administered in combination or sequentially (irrespective of the order).
Other eligibility criteria will also apply.
Participants will be assigned to 1 of 2 active therapies, also known as treatment arms,
as follows:
- Acasunlimab (100 milligrams [mg]) and pembrolizumab (400 mg) once every 6 weeks
(Q6W), or
- Docetaxel 75 milligrams per meter squared (mg/m^2) once every 3 weeks (Q3W).
The estimated trial duration for a participant will vary but may be up to 5 years,
consisting of:
- An optional 3-month pre-screening period
- A 28-day screening period
- Up to 2 years of treatment
- A 90-day safety follow-up period
- Post-treatment follow-up.
