Clinical trial · Interventional
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| JNJ-90301900 (NBTXR3) | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: JNJ-90301900 (NBTXR3)
- description
- JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume.
- interventionNames
- Drug: JNJ-90301900 (NBTXR3)
- Drug: Cetuximab
- Radiation: Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Arm B: RT alone or RT in combination with cetuximab
- description
- Investigator's choice of RT alone or RT in combination with cetuximab.
- interventionNames
- Drug: Cetuximab
- Radiation: Radiation Therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than or equal to (\>=) 60 years old * Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab * Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC * One primary tumor lesion amendable for intratumoral injection * Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following): 1. Estimated creatinine clearance \>= 30 and less than (\<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation), 2. Grade \>= 2 hearing loss or tinnitus, 3. Grade \>= 2 peripheral neuropathy, 4. New York Heart Association Class 3 5. Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (\<=) 14 or Aged \>= 75 years old * Eastern cooperative oncology group (ECOG) performance status 0 to 1 * Life expectancy \>= 6 months Exclusion Criteria: * Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin * Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC * Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy * Prior or concurrent primary malignancy (including second synchronous head \& neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent * Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization
References
Publications (1)
- DERIVEDLe Tourneau C, Takacsi-Nagy Z, Nuyts S, Thureau S, Liu F, Hoffmann C, Hackman TG, Lesnik M, Debard A, Finzi L, Devisetty K, Vivar OI, Farber LA, Nguyen F, Liem X, Natelauri E, Psyrri A, Burian M, Yu J, Yom SS. Nanoray-312: phase III study of NBTXR3 + radiotherapy +/- cetuximab in elderly, platinum-ineligible locally advanced HNSCC. Future Oncol. 2025 May;21(12):1489-1499. doi: 10.1080/14796694.2025.2496131. Epub 2025 May 5. PMID 40323213