RecruitingPhase IIInterventional

A study of JNJ-90301900 in combination with chemoradiation followed by consolidation immunotherapy for non-small cell lung cancer (NSCLC)

This study is for people with a type of advanced lung cancer (non-small cell lung cancer, Stage III) that cannot be surgically removed. It's investigating a new drug called JNJ-90301900. This drug is injected directly into the tumor and is designed to work with radiation to kill more cancer cells without harming healthy tissue too much. Researchers want to find out if adding JNJ-90301900 to the usual treatment (chemotherapy and radiation, followed by immunotherapy) can make the treatment more effective and safe. Some participants will receive the new drug, while others will get the standard treatment to compare results. The study hopes to improve outcomes for future patients.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Johnson & Johnson (Netherlands)

Enrolment target

130

Start

01 Oct 2025

Estimated completion

31 Dec 2026

Locally advanced and unresectable Stage III non-small cell lung cancer

What is this study about?

This study is looking into a new way to treat non-small cell lung cancer, which is the most common type of lung cancer. Specifically, it focuses on patients whose cancer is advanced (meaning it's large or has spread to nearby lymph nodes) but can't be removed with surgery. Even with current standard treatments, the results for this type of cancer haven't been as good as doctors would like.

The new drug being tested is called JNJ-90301900. It's different because it's injected right into the tumor. The idea is that when the tumor is then treated with radiation, JNJ-90301900 helps the radiation kill more cancer cells. Importantly, it's designed to do this without raising the risk of harm to healthy areas around the tumor. The researchers want to see if adding this new drug to the usual treatment (chemotherapy, radiation, and then immunotherapy) can help shrink tumors more effectively and is safe for patients.

By comparing results between patients who receive JNJ-90301900 and those who receive only the standard treatment, the study aims to understand if this new approach could offer a better option for people with this challenging form of lung cancer. This kind of research is vital for finding new and improved ways to fight cancer in the future.

Key takeaways

This study is testing a new drug for advanced lung cancer that cannot be surgically removed.
The new drug, JNJ-90301900, works by being injected into the tumor to potentially boost radiation therapy.
Participants will receive either the new drug with standard therapy or standard therapy alone.
The study aims to see if the new drug is both effective and safe.
There are potential benefits and risks, and you can withdraw at any time.
Your participation could help improve future treatments for lung cancer.

Who may be eligible?

To join this study, you must be an adult aged 18 or over and have been diagnosed with non-small cell lung cancer that is considered advanced (Stage IIIA or IIIB) but cannot be removed by surgery. Your doctors must also believe that the standard treatment, which includes chemotherapy, radiation, and immunotherapy, is suitable for you.

There are also some requirements about your general health. For example, your cancer must have a spot that can be injected and treated with radiation. You'll also need to be in generally good health, as assessed by a common health check for cancer patients (called an ECOG Performance Status of 0 to 1).

However, you won't be able to join if you have certain other health conditions, such as immune system problems, a recent heart attack or severe heart issues, or another type of cancer diagnosed in the last three years. You also can't participate if you have known allergies to any of the study medications, or if you have a bleeding disorder or need blood thinners that can't be stopped for the procedures.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Do you have advanced (Stage IIIA or IIIB) non-small cell lung cancer that cannot be removed by surgery?
Are you considered suitable for standard chemotherapy, radiation, and immunotherapy?
Do you have a tumor that can be injected and treated with radiation?
Are you generally in good health (ECOG Performance Status 0-1)?
Do you have any existing serious heart conditions or another cancer diagnosed in the last 3 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve several stages. Initially, if you're in the group receiving JNJ-90301900, you'll have the drug injected directly into your tumor and/or affected lymph nodes. Then, you'll receive the standard treatment, which includes chemotherapy and radiation therapy together, followed by a separate course of immunotherapy.

The study is divided into two main parts. The first part will check if the injection procedure for JNJ-90301900 is practical. The second part will compare the effectiveness and safety of JNJ-90301900 plus standard therapy against standard therapy alone. If you're in the standard treatment group, you'll receive the usual chemotherapy, radiation, and immunotherapy.

All participants will be carefully monitored for up to 24 months after their last chemotherapy and radiation treatment. This involves regular check-ups, scans, and assessments to see how you're responding to treatment and to track any side effects. You can withdraw from the study at any time.

Potential risks and benefits

There is no guaranteed benefit to you personally from taking part in this study, as the new drug, JNJ-90301900, is still being investigated. We don't yet know if it will be effective. However, based on scientific ideas, it might help radiation therapy kill more cancer cells. Even if you receive the standard treatment group, it is possible you may benefit from closer monitoring during the study. Your participation could also help doctors learn more about this type of cancer and improve treatments for future patients. Like all medical treatments, there are potential risks and side effects. These can vary from mild to severe, and in rare cases, could be life-threatening. Common known side effects might include a fast or irregular heartbeat, stomach pain, feeling sick, tiredness, feeling hot, night sweats, anxiety, feeling faint, changes in blood pressure, allergic reactions, or pain at the injection site. There's also a risk of harm to other organs. You have the right to leave the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Not provided at time of registration
Unverified
United Kingdom

Common questions

What type of cancer is this study for?

This study is for locally advanced non-small cell lung cancer (Stage III) that cannot be removed by surgery.

What is JNJ-90301900?

JNJ-90301900 is a new drug injected directly into the tumor, designed to make radiation therapy more effective in killing cancer cells.

Will I definitely receive the new drug?

Not necessarily. The study has different groups, and some participants will receive the new drug plus standard therapy, while others will receive standard therapy alone (the control group).

How long will I be followed up?

You will be monitored for up to 24 months (2 years) after your last chemotherapy and radiation treatment.

Who is running this study?

The study is sponsored by Johnson And Johnson Enterprise Innovation Inc. (Netherlands).

How to find out more

Jack Brady

jbrady16@its.jnj.com +44 7982022917 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.