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NCT06635824 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
A Phase 3 study of PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC, sponsored by Genmab.
- Active
- Registry status
- Phase 3
- Development phase
- 191
- Enrollment target
- 20
- Study locations
NCT06635824: Active Phase 3 study of PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC, sponsored by Genmab.
NCT06635824 is a Phase 3 study of PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC that is active but no longer recruiting, run by Genmab. The registered enrollment target is 191 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06635824, a Phase 3 study of PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC, is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 191 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
OS is defined as the time from date of randomization to date of death due to any cause.
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
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2024-11-25 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 3 |
What the registry record for NCT06635824 still lists
NCT06635824 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
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.
NCT06635824 names 20 study sites across 10 states, led by Georgia, Kentucky, California.
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.
What interventions are being tested in trial NCT06635824?
The interventions under investigation include: Pembrolizumab (DRUG), Docetaxel (DRUG), Acasunlimab (DRUG).
Who is sponsoring clinical trial NCT06635824?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06635824's enrollment target sits among peer trials
191 1402nd of 2000 higher than 599 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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