Last reviewed · How we verify
NCT07335380
Phase IB Trial of Preoperative Lattice-Based Hypofractionated Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma
Phase 1 trial testing Chemotherapy in Oral Cavity Squamous Cell Carcinoma in 30 participants. Not yet recruiting.
1 March 2031
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | factorial |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 April 2026 |
| Primary completion | 1 March 2031 |
| Estimated completion | 1 March 2031 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Chemotherapy (chemotherapy) — full drug profile →
- Lattice Radiotherapy (LRT)
Conditions studied
- Oral Cavity Squamous Cell Carcinoma — all drugs for Oral Cavity Squamous Cell Carcinoma →
Sponsor
NYU Langone Health — full company profile →
Who can join
18 and older, any sex, with Oral Cavity Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximum tolerated dose (MTD) of pre-operative lattice radiotherapy delivered with chemoimmunotherapy
Time frame: Up to Year 2
The BOIN (Bayesian Optimal Interval) algorithm will declare the MTD once a dose has an observed dose-limiting toxicity (DLT) rate compatible with the target toxicity level (θ = 0.20) and all higher doses are ruled out for excess risk.
Sponsor's own description
Single-arm, two-part, phase IB safety study that uses a Bayesian Optimal Interval (BOIN-12) dose-escalation scheme. Part 1 (Dose Finding) - Sentinel start at 9 Gy × 3 followed by fixed 3-patient BOIN cohorts exploring 8 Gy × 3 → 9 Gy × 3 → 10 Gy × 3. Target DLT rate θ = 0.20; ≈ 7-15 participants. Part 2 (Expansion) - Additional enrolment at the selected maximum tolerated dose (MTD) until ≈ 30 evaluable subjects (Parts 1 + 2 combined). Patients receive peaks to the primary tumor alone (Group A) or to the primary + involved nodes (Group B) at the investigators' discretion (non-random). Surgery occurs 6-8 weeks after RT; adjuvant therapy is pathology-driven.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Spatially fractionated radiation therapy for bulky tumors: a systematic review of clinical outcomes and dosimetric challenges.
Di Franco R, Mottareale R, Pezzulla D, Mercogliano S, et al · · 2026 · PMID 42174670 · DOI 10.1186/s13014-026-02860-7
Verify or expand the search:
- PubMed search for NCT07335380
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Chemotherapy
Trials testing the same drug.
- NCT07391774 — Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribocic · Phase 3 · not yet recruiting
- NCT07476287 — Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult · Phase 2 · recruiting
- NCT07392892 — A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer · Phase 2, PHASE3 · recruiting
- NCT07288034 — Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatmen · Phase 2 · recruiting
- NCT07078604 — A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negati · Phase 2 · recruiting
Other recruiting trials for Oral Cavity Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT06980038 — Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone i · Phase 2 · recruiting
- NCT07121595 — Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cel · Phase 2 · recruiting
- NCT06947668 — Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel · recruiting
- NCT06662058 — Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radi · NA · recruiting
- NCT06532279 — Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patient · Phase 2 · recruiting
Other NYU Langone Health trials
Trials by the same sponsor.
- NCT07214519 — Permanent Supportive Housing Overdose Prevention-2 Study · NA · not yet recruiting
- NCT05558267 — Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease · NA · not yet recruiting
- NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
- NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
- NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07335380 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 28 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07335380.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing