In short
Clinical trials are studying HAFNIUM OXIDE, also listed as JNJ-90301900 or NBTXR3, in people with certain cancers. These studies are looking at whether it can improve outcomes when used with radiotherapy and other cancer treatments, and they measure results such as survival and tumor response.
Key points
- Clinical trials are studying HAFNIUM OXIDE, also called JNJ-90301900 or NBTXR3, in two cancer settings. One Phase 3 study is in locally advanced head and neck squamous cell carcinoma, and one Phase 2 study is in locally advanced, unresectable stage III non-small cell lung cancer. The head and neck trial compares treatment with radiotherapy, with or without cetuximab, against the current approach and measures progression-free survival. The lung trial tests HAFNIUM OXIDE with chemoradiation and durvalumab and measures objective response rate. Both trials are authorised and are designed to see whether adding HAFNIUM OXIDE improves cancer treatment results.
Clinical trials overview
These records describe two interventional studies, which means researchers are testing a treatment plan in people with cancer. The substance being studied is HAFNIUM OXIDE, listed in the trial records as JNJ-90301900 and also named NBTXR3 in one study. Both studies are authorised and are being done in adults with specific advanced cancers.
Phase 3 trial in head and neck cancer
The first study is a Phase 3 trial in people with locally advanced head and neck squamous cell carcinoma. This trial includes 501 participants and is authorised. It is testing intratumoral JNJ-90301900 (NBTXR3), meaning the study treatment is given directly into the tumor, together with radiotherapy chosen by the investigator, with or without cetuximab (Erbitux).
The study compares JNJ-90301900 (NBTXR3) plus radiotherapy, with or without cetuximab, against radiotherapy with or without cetuximab alone. The main goal is to evaluate survival outcomes in this setting.
Phase 2 trial in lung cancer
The second study is a Phase 2 trial in people with locally advanced and unresectable stage III non-small cell lung cancer. It is authorised and plans to enroll 130 participants. The trial is testing JNJ-90301900 given by intratumoral use together with chemoradiation and durvalumab.
The goal is to see whether adding JNJ-90301900 to this treatment plan can improve the objective response rate, or ORR, based on independent central review and RECIST v1.1 rules. RECIST v1.1 is a standard way to measure how tumors change on scans.
What the trials measure
The head and neck study uses progression-free survival as its primary outcome. This means the researchers measure the time from randomization until the cancer comes back in the same area, gets worse locally or in a distant site, or the person dies from any cause.
The lung study uses ORR as its primary outcome, measured by independent central review. ORR tells researchers how many participants have a measurable tumor response to treatment.
Who may take part
These trials are for people with the specific cancer types named in the records. The first study is for people with locally advanced head and neck squamous cell carcinoma, and the second is for people with locally advanced, unresectable stage III non-small cell lung cancer.
In simple terms, locally advanced means the cancer has grown beyond its first place but has not spread widely, and unresectable means surgery is not an option to remove it.
Key trial terms
- Randomization means participants are assigned to treatment groups by chance, so the groups can be compared fairly.
- Radiotherapy is treatment with radiation to damage cancer cells.
- Cetuximab is listed in the head and neck study as Erbitux.
- Durvalumab is part of the lung cancer treatment plan in the Phase 2 study.
- Independent Central Review means outside reviewers check the results in a standard way.