Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
18 Years and older, Male and Female
GCT1046-06 (primary)
NCI-2025-02123
2024-512998-27-00
jRCT2051240178
Summary
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 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 metastatic setting.
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.
Eligibility
- Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV).
- Participant has progressed on or after receiving:
- One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the metastatic disease setting; OR
- No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the metastatic disease setting.
- Participant must have positive tumor PD-L1 expression (tumor cells =1%) determined prospectively on a tumor sample from the metastatic setting at a sponsor-designated central laboratory.
- Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.
- Participant has a life expectancy of =3 months.
- Participant must have adequate organ and bone marrow function, per laboratory test results within 7 days of trial treatment. Key
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.