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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06635824

Public ClinicalTrials.gov record NCT06635824. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06635824
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Genmab
Industry
Enrollment
191 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 25, 2024 (Actual)
Primary completion
Jul 30, 2027 (Estimated)
Completion
Sep 30, 2028 (Estimated)
Last update posted
Oct 6, 2026

2024 – 2028

United States locations

U.S. sites
36
U.S. states
18
U.S. cities
31
Facility City State ZIP Site status
Arizona Blood and Cancer Specialists Tucson Arizona 85712 —
Usc Norris Comprehensive Cancer Center Los Angeles California 90089 —
Kaiser Permanente Vallejo Medical Center Vallejo California 94589 —
Ocala Oncology Center P.L. Ocala Florida 34474 —
Orlando Regional Medical Center Orlando Florida 32806 —
University Cancer & Blood Center, LLC Athens Georgia 30607 —
Piedmont Cancer Institute Atlanta Atlanta Georgia 30318 —
Piedmont Cancer Institute - Sandy Springs (Atlanta) Office Atlanta Georgia 30328 —
Piedmont Cancer Institute - Fayetteville Office Fayetteville Georgia 30214 —
Piedmont Cancer Institute - Newnan Office Newnan Georgia 30265 —
Piedmont Cancer Institute - Stockbridge Office Stockbridge Georgia 30281 —
Kaiser Foundation Hospitals Honolulu Hawaii 96817 —
University of Illinois Chicago Illinois 60612 —
Community Cancer Center East Medical Oncology Hematology Indianapolis Indiana 46219 —
Baptist Health Lexington Lexington Kentucky 40503 —
Norton Cancer Institute Louisville Kentucky 40202 —
Pikeville Medical Center Pikeville Kentucky 41501 —
Washington University School of Medicine St Louis Missouri 63110 —
St. Francis Hospital - Grand Island Grand Island Nebraska 68803 —
Oncology Hematology West Omaha Nebraska 68124 —
Oncology Hematology West, PC dba Nebraska Cancer Specialists Omaha Nebraska 68130 —
Stony Brook University Medical Center|University Medical Center Stony Brook New York 11790 —
Novant Health Pharmacy Charlotte North Carolina 28204 —
Novant Health Oncology Specialists Winston-Salem North Carolina 27103 —
University of Pennsylvania Health System Philadelphia Pennsylvania 19104 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Avera Cancer Institute Sioux Falls South Dakota 57105 —
Parkridge Medical Center Chattanooga Tennessee 37404 —
University of Tennessee Medical Center Cancer Institute Knoxville Tennessee 37920 —
Midtown Tennessee Oncology Nashville Tennessee 37203 —
Tennessee Oncology Nashville Tennessee 37205 —
Texas Oncology-Austin Midtown Austin Texas 78705 —
Texas Oncology-Austin Central Austin Texas 78731 —
South Austin Cancer Ctr Austin Texas 78745 —
University of Virginia Hematology and Oncology Charlottesville Virginia 22903 —
Cancer Institute At Swedish Med Ctr Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 211 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06635824, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 6, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06635824 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →