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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 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Pembrolizumab
  • DRUG Docetaxel
  • DRUG Acasunlimab

Study Locations (20)

Georgia

  • University Cancer & Blood Center, LLC — Athens
  • Piedmont Cancer Institute Atlanta — Atlanta
  • Piedmont Cancer Institute - Sandy Springs (Atlanta) Office — Atlanta
  • Piedmont Cancer Institute - Fayetteville Office — Fayetteville
  • Piedmont Cancer Institute - Newnan Office — Newnan
  • Piedmont Cancer Institute - Stockbridge Office — Stockbridge

Kentucky

  • Baptist Health Lexington — Lexington
  • Norton Cancer Institute — Louisville
  • Pikeville Medical Center — Pikeville

California

  • Usc Norris Comprehensive Cancer Center — Los Angeles
  • Kaiser Permanente Vallejo Medical Center — Vallejo

Florida

  • Ocala Oncology Center P.L. — Ocala
  • Orlando Regional Medical Center — Orlando

Nebraska

  • St. Francis Hospital - Grand Island — Grand Island
  • Oncology Hematology West — Omaha

Arizona

  • Arizona Blood and Cancer Specialists — Tucson

Hawaii

  • Kaiser Foundation Hospitals — Honolulu

Illinois

  • University of Illinois — Chicago

Trial Details

FieldValue
Enrollment Target 191 participants
Start Date 2024-11-25
Est. Completion 2028-09-30
Phase Phase 3

Sponsor

Genmab

59 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06635824

The ClinicalTrials.gov registry entry for NCT06635824 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 191 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06635824 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Georgia, Kentucky, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06635824 about?

NCT06635824 is a clinical study titled "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)-...

What is the current status of trial NCT06635824?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 191 participants. The study started on 2024-11-25. Estimated completion is 2028-09-30.

What conditions does trial NCT06635824 study?

This clinical trial studies the following conditions: PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06635824?

The interventions under investigation include: Pembrolizumab (DRUG), Docetaxel (DRUG), Acasunlimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06635824?

This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06635824 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial