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NCT05807048 · ClinicalTrials.gov registry record · Phase 2
Daratumumab in STK11 Mutated NSCLC
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT05807048: Completed Phase 2 study, sponsored by NYU Langone Health.
NCT05807048 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05807048, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a single-arm study of daratumumab in metastatic non-small cell lung cancer (NSCLC) patients with an STK11/LKB1 mutation. Patients will have received previous standard of care treatment including chemotherapy, immunotherapy and targeted therapy. Patients will be treated with the standard subcutaneous dosing of daratumumab (weekly for 8 administrations, then every 2 weeks for 8 administrations then every 4 weeks until progression). All follow-up visits and imaging will be performed as per standard of care. This is a signal finding study and an overall response rate ≥20% is considered clinically meaningful.
Primary Outcome
ORR is the percentage of patients who best response recorded from study enrollment until disease progression is a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where: CR = disappearance of all target lesions; and PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Interventions
- DRUG Daratumumab and Hyaluronidase-fihj
- DRUG Pre-Intervention Medication
- DRUG Post-Intervention Medication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2025-11-11 |
| Phase | Phase 2 |
What the finished NCT05807048 record still lists
NCT05807048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Daratumumab and Hyaluronidase-fihj is the first listed.
NCT05807048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05807048 about?
NCT05807048 is a clinical study titled "Daratumumab in STK11 Mutated NSCLC". This is a single-arm study of daratumumab in metastatic non-small cell lung cancer (NSCLC) patients with an STK11/LKB1 mutation. Patients will have received previous standard of care treatment including chemotherapy, immunotherapy and targeted therapy. Patients will be treated with the standard subc...
What is the current status of trial NCT05807048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2023-06-01. Estimated completion is 2025-11-11.
What interventions are being tested in trial NCT05807048?
The interventions under investigation include: Daratumumab and Hyaluronidase-fihj (DRUG), Pre-Intervention Medication (DRUG), Post-Intervention Medication (DRUG).
Who is sponsoring clinical trial NCT05807048?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05807048's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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