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NCT06088771 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06088771 is a Phase 1 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 21 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06088771, a Phase 1 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC). The study will include participants with a confirmed diagnosis of NSCLC who are deemed to be surgical candidates, or patients who have a smoking history and radiographic findings highly suggestive if a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy. On Day 1, participants will receive neoadjuvant therapy consisting of 600 mg of dupilumab (2 SC injections of 300 mg) and 350 mg of IV cemiplimab. Participants will undergo standard of care surgery, which will be scheduled within 7 days of Day 15. Participants will be followed up 30 days following administration of dupilumab and cemiplimab for adverse event (AE) and dose limiting toxicity (DLT) monitoring. Participants will be offered adjuvant therapy as per standard of care, outside the context of this clinical treatment, and undergo subsequent standard of care monitoring for recurrence. The study team will monitor the status of the participant through chart review, or by telephone should the patient not continue to follow with a physician at Mount Sinai, for up to 5 years.
Conditions Studied
Interventions
- BIOLOGICAL Cemiplimab
- BIOLOGICAL Dupilumab
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-03-08 |
| Est. Completion | 2027-04-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06088771
The ClinicalTrials.gov registry entry for NCT06088771 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cemiplimab is the first listed.
NCT06088771 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06088771 about?
NCT06088771 is a clinical study titled "Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC". This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC). The study will include participants with a confirmed diagnosis of NSCLC who are deemed to be surgical candidates, or pa...
What is the current status of trial NCT06088771?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2024-03-08. Estimated completion is 2027-04-22.
What conditions does trial NCT06088771 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06088771?
The interventions under investigation include: Cemiplimab (BIOLOGICAL), Dupilumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06088771?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06088771 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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