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Clinical Trials in the UK / NCT06635824
Active, not recruiting Phase 3

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

NCT06635824 · tracked via the Priya Life Science UK tracker
Sponsor
Genmab
Phase
Phase 3
Started
2024-11-25
Last updated
2026-09-09

Condition(s) studied

PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC

Investigational drug(s) / intervention(s)

AcasunlimabPembrolizumabDocetaxel

Acasunlimab: IV infusion

Pembrolizumab: IV infusion

Docetaxel: IV infusion

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (247)

FacilityCityRegionStatus
Arizona Blood and Cancer Specialists Tucson Arizona
Usc Norris Comprehensive Cancer Center Los Angeles California
Kaiser Permanente Vallejo Medical Center Vallejo California
Ocala Oncology Center P.L. Ocala Florida
Orlando Regional Medical Center Orlando Florida
University Cancer & Blood Center, LLC Athens Georgia
Piedmont Cancer Institute Atlanta Atlanta Georgia
Piedmont Cancer Institute - Sandy Springs (Atlanta) Office Atlanta Georgia
Piedmont Cancer Institute - Fayetteville Office Fayetteville Georgia
Piedmont Cancer Institute - Newnan Office Newnan Georgia
Piedmont Cancer Institute - Stockbridge Office Stockbridge Georgia
Kaiser Foundation Hospitals Honolulu Hawaii
University of Illinois Chicago Illinois
Community Cancer Center East Medical Oncology Hematology Indianapolis Indiana
Baptist Health Lexington Lexington Kentucky
Norton Cancer Institute Louisville Kentucky
Pikeville Medical Center Pikeville Kentucky
Washington University School of Medicine St Louis Missouri
St. Francis Hospital - Grand Island Grand Island Nebraska
Oncology Hematology West Omaha Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists Omaha Nebraska
Stony Brook University Medical Center|University Medical Center Stony Brook New York
Novant Health Pharmacy Charlotte North Carolina
Novant Health Oncology Specialists Winston-Salem North Carolina
University of Pennsylvania Health System Philadelphia Pennsylvania
Allegheny General Hospital Pittsburgh Pennsylvania
Avera Cancer Institute Sioux Falls South Dakota
Parkridge Medical Center Chattanooga Tennessee
University of Tennessee Medical Center Cancer Institute Knoxville Tennessee
Midtown Tennessee Oncology Nashville Tennessee
Tennessee Oncology Nashville Tennessee
Texas Oncology-Austin Midtown Austin Texas
Texas Oncology-Austin Central Austin Texas
South Austin Cancer Ctr Austin Texas
University of Virginia Hematology and Oncology Charlottesville Virginia
Cancer Institute At Swedish Med Ctr Seattle Washington
Hospital Italiano de La Plata La Plata Buenos Aires
Centro de Investigacion Pergamino S.A. Pergamino Buenos Aires
Instituto Medico Especializado Alexander Fleming Buenos Aires Ciudad Autonoma Buenos Aires
Sanatorio Parque S.A. Rosario Santa Fe Province

+ 207 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Genmab trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06635824 on ClinicalTrials.gov ↗ ← All trials in the UK