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NCT07428148 · ClinicalTrials.gov registry record · Phase 1
Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma
A Phase 1 study, sponsored by NYU Langone Health.
- Not yet
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT07428148 is a Phase 1 study that has not yet begun recruiting, run by NYU Langone Health. The registered enrollment target is 60 participants.
The verdict
NCT07428148, a Phase 1 study, has not yet begun recruiting, sponsored by NYU Langone Health.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This single-arm Phase I/II trial evaluates induction chemoimmunotherapy combined with lattice radiotherapy (LRT) in patients with non-low risk oropharyngeal squamous cell carcinoma and primary tumor ≥3 cm or primary tumor and pathologic lymph node ≥3 cm in longest dimension. BOIN12 adaptive dose-finding will guide dose across two anatomical cohorts-primary-tumor only (P) and primary + largest involved node (PN)-with a total target accrual of about 60 evaluable patients. Dose-limiting toxicity is monitored separately in each cohort. If both tolerate the same dose, that unified optimal biological dose (OBD) advances to Phase II; if tolerability differs, the PN-specific OBD expands while the P cohort is analyzed descriptively. After induction, imaging determines response: patients achieving ≥50% volumetric tumor shrinkage receive hypofractionated chemoradiation, whereas those with \<50% shrinkage are treated with conventional fractionation, personalizing definitive therapy according to early safety and efficacy signals.
Interventions
- DRUG Induction Chemo-Immunotherapy
- RADIATION Lattice Radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-05 |
| Est. Completion | 2033-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07428148
The ClinicalTrials.gov registry entry for NCT07428148 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 60 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 2 interventions - of which Induction Chemo-Immunotherapy is the first listed.
NCT07428148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07428148 about?
NCT07428148 is a clinical study titled "Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma". This single-arm Phase I/II trial evaluates induction chemoimmunotherapy combined with lattice radiotherapy (LRT) in patients with non-low risk oropharyngeal squamous cell carcinoma and primary tumor ≥3 cm or primary tumor and pathologic lymph node ≥3 cm in longest dimension. BOIN12 adaptive dose-fin...
What is the current status of trial NCT07428148?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-05. Estimated completion is 2033-05.
What interventions are being tested in trial NCT07428148?
The interventions under investigation include: Induction Chemo-Immunotherapy (DRUG), Lattice Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT07428148?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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