RecruitingPHASE2INTERVENTIONAL

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 common type of lung cancer called non-small cell lung cancer that has grown locally but can't be removed by surgery. Researchers want to see if adding a new drug, JNJ-90301900, to the usual treatment (chemotherapy and radiation) makes the standard treatment more effective. After chemotherapy and radiation, people in the study will also receive another immunotherapy drug called durvalumab. The main goal is to find out if this combination helps shrink the cancer more successfully in a larger number of patients. This is a Phase 2 study, meaning it's exploring how well the treatment works and its safety.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Enrolment target

130

Start

06 Dec 2024

Estimated completion

31 Dec 2028

Carcinoma, Non-Small-Cell Lung

What is this study about?

This research study is investigating a new approach to treating non-small cell lung cancer, which is the most common type of lung cancer. Specifically, it's for people whose cancer has spread a bit within the chest but can't be surgically removed. The standard treatment for this situation usually involves a combination of chemotherapy (strong drugs to kill cancer cells) and radiation therapy (using high-energy rays to destroy cancer cells), followed by a type of immunotherapy called durvalumab.

In this study, doctors are looking at whether adding a new experimental drug, JNJ-90301900, to this standard treatment can improve how well patients respond. They want to see if more people's tumours shrink or disappear compared to the standard approach. JNJ-90301900 is given before a combination of chemotherapy with drugs like Carboplatin and Paclitaxel, and radiation. This is then followed by the immunotherapy called Durvalumab.

The main idea behind this study is to explore if this new drug can boost the effects of the existing treatments, potentially leading to better outcomes for patients with this specific stage of lung cancer.

Key takeaways

This study is testing a new drug (JNJ-90301900) for locally advanced lung cancer.
It combines the new drug with standard chemotherapy, radiation, and another immunotherapy.
The main goal is to see if more patients respond well to this new combination.
It's for people with Stage III non-small cell lung cancer that cannot be surgically removed.
Participation involves close monitoring and potentially more hospital visits.

Who may be eligible?

To join this study, your doctor must decide that the usual treatment for non-small cell lung cancer (chemotherapy, radiation, and durvalumab) is suitable for you. You must have been diagnosed with non-small cell lung cancer within the last three months, and it needs to be locally advanced (Stage III) but not suitable for surgery. Your cancer must have at least one spot that can be injected and is suitable for radiation.

There are also some reasons why you might not be able to join. For example, if you have certain problems with your immune system or have had an organ transplant requiring special medicines. You also can't have had a heart attack, serious chest pain, or severe heart failure within the last three months. Having another cancer recently (within the last three years) or known severe allergies to the study drugs would also prevent you from taking part. Finally, if you have a bleeding disorder or have had serious blood clots recently, you might not be eligible.

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.

Have you been diagnosed with non-small cell lung cancer within the last 3 months?
Is your lung cancer locally advanced (Stage III) and not suitable for surgery?
Are you considered fit enough for standard chemotherapy and radiation treatment?
Do you have a general good level of health and physical ability (ECOG 0-1)?
Have you *not* had specific heart problems (like a heart attack or severe angina) in the last 3 months?
Have you *not* had another cancer within the last 3 years?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new drug JNJ-90301900, along with standard chemotherapy and radiation therapy. This will be followed by treatment with durvalumab. The specific details of how often you'll visit the hospital and for how long will be explained by the study team, as it depends on the treatment schedule. You'll have various tests, scans, and possibly blood samples taken throughout the study to monitor your health and how the treatment is working. It's important to remember that participating in a clinical trial often involves more hospital visits and tests than standard care. You will be closely monitored by medical professionals for the duration of the study.

Potential risks and benefits

Taking part in a clinical trial has potential benefits, such as receiving a new and potentially more effective treatment that isn't yet widely available. You'll also receive close medical attention and monitoring. However, there are also risks, as new treatments can have unexpected side effects, and the new drug might not work for everyone. The standard treatments (chemotherapy and radiation) also have known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (41)

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

University of Connecticut Health Center
Verified postcode
Farmington, United States· Recruiting
Yale University
Verified postcode
New Haven, United States· Recruiting
University of Miami
Verified postcode
Miami, United States· Recruiting
Orlando Health Cancer Institute
Verified postcode
Orlando, United States· Recruiting
Emory University Winship Cancer Institute
Verified postcode
Atlanta, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Recruiting
Rutgers Cancer Institute of New Jersey
Verified postcode
New Brunswick, United States· Recruiting
NYU Langone Health
Verified postcode
New York, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
University of North Carolina at Chapel Hill
Verified postcode
Chapel Hill, United States· Recruiting
FirstHealth of the Carolinas
Verified postcode
Pinehurst, United States· Recruiting
University Hospitals Cleveland Medical Center
Verified postcode
Cleveland, United States· Recruiting

Common questions

What is JNJ-90301900?

It's a new experimental drug being tested to see if it can improve how well standard lung cancer treatments work.

What is 'Phase 2' of a clinical trial?

Phase 2 means the study is mainly looking at how well the new treatment works and continuing to check its safety, usually in a larger group of people than Phase 1.

What is 'locally advanced unresectable Stage III NSCLC'?

It means the lung cancer has spread within the local area of your chest but can't be completely removed by surgery.

What is 'consolidation immunotherapy'?

This is a treatment (like durvalumab in this study) given after your main treatment (chemotherapy and radiation) to help strengthen your immune system's fight against any remaining cancer cells.

Will I definitely get the new drug?

This study is testing the new drug alongside standard care, so if you are eligible and enrol, you will receive JNJ-90301900 with your other treatments.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

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