Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04892173 | JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC | PHASE3 | RECRUITING | 500 | — | — | Dec 10, 2021 | Jun 30, 2028 | Jun 5, 2026 | 191 | United States, Austria +25 |
PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm A: JNJ-90301900 (NBTXR3) | EXPERIMENTAL | 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. |
| Arm B: RT alone or RT in combination with cetuximab | ACTIVE_COMPARATOR | Investigator's choice of RT alone or RT in combination with cetuximab. |
| Name | Type | Description |
|---|---|---|
| JNJ-90301900 (NBTXR3) | DRUG | Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation. |
| Cetuximab | DRUG | Solution for infusion |
| Radiation Therapy | RADIATION | Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period. |
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...