Active Not RecruitingPhase 3NCT06635824

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

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.

Checked against the public recordLast updated Aug 4, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations247
SponsorGenmab
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Key Inclusion Criteria: * 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 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 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 exclusion criteria may apply.

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

04
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: Aug 4, 2026. Always confirm current availability with the study team.

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