Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)

Summary

Objectives

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:

1. must have lung cancer that has metastasized (spread)

2. have tumors that are positive for the PD-L1 protein (a biomarker that may be
predictive of response to therapy)

3. will have been previously treated with a PD-1/PD-L1-inhibitor and a
platinum-containing cancer therapy administered in combination or sequentially.

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 mg) and pembrolizumab (400 mg) once every 6 weeks (Q6W), or

- Docetaxel 75 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 56-day 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.