JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

Active:	Yes
Cancer Type:	Head and Neck Cancer Unknown Primary	NCT ID:	NCT04892173
Trial Phases:	Phase III	Protocol IDs:	NANORAY-312 (primary) NCI-2021-09147 2024-520386-31-00 NANORAY-312
Eligibility:	60 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Johnson & Johnson Enterprise Innovation Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04892173

Summary

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).

Objectives

Participants will undergo a screening assessment over a period of less than or equal to
(<=) 28 days to determine eligibility.

Eligible participants will be treated by the Investigator's choice of RT alone or RT in
combination with cetuximab. Following the Investigator's choice, participants will be
randomized in a 1:1 ratio:

- Arm A: JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by
investigator's choice of RT alone or RT in combination with cetuximab

- Arm B: Investigator's choice of RT alone or RT in combination with cetuximab

All participants (Arm A and Arm B) will receive 70 Gy in 35 fractions over a 7 week
period.

An EOT visit will be performed 4 weeks after the completion of RT. Follow-up visits will
start at 12 weeks post-RT completion, and will continue every 12 weeks for 2 years, and
then every 24 weeks thereafter until death; the participant is determined to be lost to
follow up; withdrawal of consent; or the end of the study, whichever occurs first.
Participants who have received further anti-cancer therapy for the study disease and/or
have had disease progression/recurrence will be followed only for survival information

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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