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JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
Carcinoma, Squamous Cell
Clinicaltrials.gov:
EU CTIS:
#2024-520386-31-00
Other:
#NANORAY-312
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Trials at a glance
Status
Enrolling
Condition
Carcinoma, Squamous Cell
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Cetuximab
JNJ-90301900 (NBTXR3)
Radiation Therapy
Age
60+ years old
Biological sex
All
Placebo?
No
Trial start date
December 10, 2021
Trial end date
June 30, 2028
CT.gov ID
#NCT04892173
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
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).
Primary outcome measures
- Progression-free Survival (PFS) Based on Independent Central Review (ICR)
Secondary outcome measures
- Overall Survival (OS)
- Local-regional control
- Distant control
- Quality of Life over time - QLQ H&N35
- Quality of Life over time - EQ 5D 5L
- Safety across duration of study - AEs
- Objective Response Rate (ORR)
- Duration of Overall Response
- Head and Neck Cancer Specific Event-Free Survival
- Head and Neck Cancer-Specific Survival
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