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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

10 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

JNJ-90301900 – This medication is administered in combination with chemoradiation therapy, followed by durvalumab, for patients with locally advanced and unresectable Stage III non-small cell lung cancer. It is currently being studied in a Phase 2 clinical trial to evaluate its effectiveness as a radioenhancer, aiming to improve the objective response rate in this patient group. The main therapeutic indication is for enhancing the effects of radiation therapy in lung cancer treatment. At the molecular level, JNJ-90301900 is believed to enhance the sensitivity of cancer cells to radiation, although specific details of its mechanism are still under investigation. It falls under the pharmacological classification of radioenhancers, which are agents used to increase the efficacy of radiation therapy.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518276-32-00Protocol code90301900NSC2001Estimated enrolment130 patientsSponsorJohnson & Johnson Enterprise Innovation Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).