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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: Clinical Trial Phase 1 study, sponsored by NYU Langone Health.

NCT07428148 is a Phase 1 study that has not yet begun recruiting, run by NYU Langone Health. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Phase I only - measured as the percentage of participants with DLTs during the initial treatment window.

Interventions

  • DRUG Induction Chemo-Immunotherapy
  • RADIATION Lattice Radiotherapy

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2026-05
Est. Completion 2033-05
Phase Phase 1
NYU Langone Health

1,164 total trials

What is known before NCT07428148 opens enrollment

NCT07428148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Induction Chemo-Immunotherapy is the first listed.

NCT07428148 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT07428148's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT07428148, the US trial registry maintained by the National Library of Medicine. NCT07428148 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.