Health Trials

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

ConditionCarcinoma, Squamous Cell
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorJohnson & Johnson Enterprise Innovation Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Arm A: JNJ-90301900 (NBTXR3)Experimental treatment 3 interventions
Group B: Arm B: RT alone or RT in combination with cetuximabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS) Based on Independent Central Review (ICR)

PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.

Time frame
30 months following first randomized participant

Secondary outcomes

1

Overall Survival (OS)

Time from randomization to death from any cause.

Time frame
48 months following first randomized participant
2

Local-regional control

Time to local regional progression: time from randomization to local-regional progression (including recurrence) or death, whichever occurs first.

Time frame
48 months following first randomized participant
3

Distant control

Time to distant progression: time from randomization to distant progression or death, whichever occurs first.

Time frame
48 months following first randomized participant
4

Quality of Life over time - QLQ H&N35

Change from baseline over time in symptoms, function, and health related QOL using the European organisation for research and treatment of cancer (EORTC) questionnaire-head and neck cancer module (QLQ H\&N35).

Time frame
48 months following first randomized participant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johnson & Johnson Enterprise Innovation Inc.

Lead sponsor

Source ClinicalTrials.gov
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