Study of JNJ-90301900 with Chemoradiation and Durvalumab for Patients with Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Stage III non-small cell lung cancer (NSCLC), which is advanced and cannot be removed by surgery. The study will explore a new treatment approach using a drug called JNJ-90301900, also known as hafnium oxide, which is given as an injection directly into the tumor. This drug is being tested to see if it can enhance the effects of radiation therapy, a method known as a radioenhancer.

The purpose of the study is to determine if adding JNJ-90301900 to the standard treatment of chemotherapy and radiation, followed by a medication called durvalumab, can improve the response rate in patients with this type of lung cancer. Durvalumab is a type of immunotherapy, which helps the body’s immune system fight cancer. The study will compare the effects of this new combination treatment to the standard treatment alone.

Participants in the study will receive the combination of JNJ-90301900, chemotherapy, and radiation, followed by durvalumab. The study will monitor how well the cancer responds to this treatment over time. The trial is expected to continue for several years to gather enough information about the effectiveness and safety of this new treatment approach.

1 introduction to the trial

The trial is designed for individuals with locally advanced and unresectable Stage III non-small cell lung cancer.

The main goal is to evaluate the effectiveness of the drug JNJ-90301900 when used with standard treatments.

2 eligibility confirmation

Eligibility is confirmed based on specific criteria, including a confirmed diagnosis of non-small cell lung cancer and a life expectancy of at least six months.

A target lesion must be present that can be treated with the study’s methods.

3 treatment phase

The treatment involves the use of JNJ-90301900, administered as an injection directly into the tumor.

This is combined with chemoradiation, a standard treatment that uses chemotherapy and radiation therapy together.

Following this, a medication called durvalumab is given to help the immune system fight cancer.

4 monitoring and assessment

Throughout the trial, the response to treatment is monitored using imaging techniques.

The primary measure of success is the objective response rate, which assesses how well the cancer responds to the treatment.

5 completion of the trial

The trial is expected to conclude by the end of 2028.

Final assessments will determine the overall effectiveness of the treatment combination.

Who Can Join the Study?

Must have locally advanced and unresectable stage III lung cancer. This means the cancer is in the lungs and cannot be removed by surgery.
Must have a confirmed diagnosis of NSCLC (non-small cell lung cancer) through a test that examines cells or tissues.
Must be eligible for the usual treatment for this type of lung cancer, which includes a combination of chemotherapy and radiation therapy, followed by a specific medication called durvalumab.
Must have at least one area of cancer in the lungs or nearby lymph nodes that can be treated with a special injection and radiation therapy.
Must have a documented tumor proportion score (TPS) for PD-L1. This is a test that measures a protein in the cancer cells, done by a local or central laboratory.
Must have an ECOG Performance Status of 0-1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Must have a life expectancy of at least 6 months at the time of giving consent to participate in the study.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients with other types of cancer besides the specific lung cancer being studied cannot participate.
Patients who have had previous treatments that might interfere with the study cannot participate.
Patients with certain medical conditions that could affect the study results cannot participate.
Patients who are unable to follow the study procedures or attend required visits cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have allergies to the study medication or its ingredients cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients with a history of certain heart conditions cannot participate.
Patients with severe infections or uncontrolled illnesses cannot participate.
Patients who have had a recent major surgery cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Hospital Universitario De Navarra	Pamplona	Spain
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Netherlands Cancer Institute	Amsterdam	The Netherlands
Hopital Beaujon	Clichy	France
Arfbbfxjyr Pbrnrvdt Hrvmpfcj Dn Mctgpsiqf	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	05.04.2025
Spain	Recruiting	05.04.2025
The Netherlands	Recruiting	05.04.2025

Trial locations

Investigated drugs:

HAFNIUM OXIDE

JNJ-90301900 is an experimental medication being tested to see if it can enhance the effects of radiation therapy. It is used in combination with other treatments to potentially improve the response rate in patients with a specific type of lung cancer that cannot be surgically removed.

Durvalumab is a medication that helps the immune system fight cancer. It is used after initial treatments to help prevent the cancer from coming back or growing.

Chemoradiation is a combination of chemotherapy and radiation therapy. Chemotherapy uses drugs to kill cancer cells, while radiation therapy uses high-energy rays to target and destroy cancer cells. This combination is used to treat lung cancer that cannot be removed with surgery.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and squamous cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, leading to the formation of tumors. In its locally advanced and unresectable Stage III form, the cancer has spread to nearby tissues or lymph nodes but not to distant body parts. The progression involves the cancer cells invading surrounding structures, making surgical removal challenging. As the disease advances, it can cause symptoms like persistent cough, chest pain, and difficulty breathing. The focus is often on managing the disease and improving the quality of life for those affected.

Trial ID:

2024-518276-32-00

Protocol code:

90301900NSC2001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of JNJ-90301900 with Chemoradiation and Durvalumab for Patients with Advanced Non-Small Cell Lung Cancer

What is this study about?

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