RecruitingPhase 3

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

United States500 participantsStarted 2021-12-10

Plain-language 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).

Who can participate

Age range60 Years

SexALL

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Inclusion criteria

✓. Estimated creatinine clearance \>= 30 and less than (\<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
✓. Grade \>= 2 hearing loss or tinnitus,
✓. Grade \>= 2 peripheral neuropathy,
✓. New York Heart Association Class 3
✓. Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (\<=) 14 or Aged \>= 75 years old

What they're measuring

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

Timeframe: 30 months following first randomized participant

Trial details

NCT IDNCT04892173

SponsorJohnson & Johnson Enterprise Innovation Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

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