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

Study 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 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAcasunlimab and Pembrolizumab

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 6, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?247 U.S. locations

Locations may change over time.

Who runs it?Genmab

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Genmab
Interventions being studied: Drug: Acasunlimab; Drug: Pembrolizumab; Drug: Docetaxel

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Locally advanced→Metastatic or stage IV→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
Participant has histologically or cytologically confirmed locally advanced (unresectable stage IIIB/C) or 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 locally advanced (unresectable stage IIIB/C) or 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 locally advanced (unresectable stage IIIB/C) or metastatic disease setting.
Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the locally advanced (unresectable stage IIIB/C) or 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

Reasons someone may not be able to joinExclusion 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 targeted therapies.
Participants with newly identified, untreated or 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Arizona Blood and Cancer SpecialistsTucson, Arizona
Usc Norris Comprehensive Cancer CenterLos Angeles, California
Kaiser Permanente Vallejo Medical CenterVallejo, California
Ocala Oncology Center P.L.Ocala, Florida
Orlando Regional Medical CenterOrlando, Florida
University Cancer & Blood Center, LLCAthens, Georgia
Piedmont Cancer Institute AtlantaAtlanta, Georgia
Piedmont Cancer Institute - Sandy Springs (Atlanta) OfficeAtlanta, Georgia
Piedmont Cancer Institute - Fayetteville OfficeFayetteville, Georgia
Piedmont Cancer Institute - Newnan OfficeNewnan, Georgia
Piedmont Cancer Institute - Stockbridge OfficeStockbridge, Georgia
Kaiser Foundation HospitalsHonolulu, Hawaii

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 6, 2026. Always confirm current availability with the study team.

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