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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 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05807048
The ClinicalTrials.gov registry entry for NCT05807048 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Daratumumab and Hyaluronidase-fihj is the first listed.
NCT05807048 reports 0 study locations.
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.
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