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Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
Trial Status: active
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.
Inclusion Criteria
Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV with known subtype).
Participant has progressed radiographically 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
Exclusion Criteria
Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten rat sarcoma virus (KRAS), B-Raf proto-oncogene (BRAF) mutations, and MET proto-oncogene; receptor tyrosine kinase (MET) exon 14 skipping mutations/MET amplification. NOTE: MET amplification testing is optional based on local availability of the test.
Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to approved targeted therapies.
Participants with newly identified or known unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
Prior treatment with docetaxel for NSCLC.
Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment. Note: Other protocol-defined inclusion and exclusion criteria may apply.
Additional locations may be listed on ClinicalTrials.gov for NCT06635824.
