Table of Contents
- Clinical trials overview
- Phase 3 trial in head and neck cancer
- Phase 2 trial in lung cancer
- What the trials measure
- Who may take part
- Key trial terms
Clinical trials overview
These records describe two interventional studies, which means researchers are testing a treatment plan in people with cancer.[1][2] The substance being studied is HAFNIUM OXIDE, listed in the trial records as JNJ-90301900 and also named NBTXR3 in one study.[1] Both studies are authorised and are being done in adults with specific advanced cancers.[1][2]
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.[1] This trial includes 501 participants and is authorised.[1] 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).[1]
The study compares JNJ-90301900 (NBTXR3) plus radiotherapy, with or without cetuximab, against radiotherapy with or without cetuximab alone.[1] The main goal is to evaluate survival outcomes in this setting.[1]
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.[2] It is authorised and plans to enroll 130 participants.[2] The trial is testing JNJ-90301900 given by intratumoral use together with chemoradiation and durvalumab.[2]
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.[2] RECIST v1.1 is a standard way to measure how tumors change on scans.[2]
What the trials measure
The head and neck study uses progression-free survival as its primary outcome.[1] 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.[1]
The lung study uses ORR as its primary outcome, measured by independent central review.[2] ORR tells researchers how many participants have a measurable tumor response to treatment.[2]
Who may take part
These trials are for people with the specific cancer types named in the records.[1][2] 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.[1][2]
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.[2]
Key trial terms
Randomization means participants are assigned to treatment groups by chance, so the groups can be compared fairly.[1]
Radiotherapy is treatment with radiation to damage cancer cells.[1][2]
Cetuximab is listed in the head and neck study as Erbitux.[1]
Durvalumab is part of the lung cancer treatment plan in the Phase 2 study.[2]
Independent Central Review means outside reviewers check the results in a standard way.[2]
