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.
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.
