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Study on Inupadenant, Carboplatin, and Pemetrexed for Adults with Metastatic Non-Small Cell Lung Cancer After Immunotherapy

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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 nonsquamous non-small cell lung cancer. This is a common form of lung cancer that does not involve the squamous cells, which are flat cells found in the lining of the airways. The study is testing a new treatment that combines a medication called Inupadenant HCl with two other cancer drugs, carboplatin and pemetrexed. Inupadenant HCl is an experimental drug that is being tested to see if it can help improve the effectiveness of the other two medications in treating this type of lung cancer.

The purpose of the study is to evaluate how well this combination of drugs works and how safe it is for patients who have already tried other treatments, such as immunotherapy, but have not seen improvement. The study is divided into two parts. In the first part, researchers will determine the best dose of Inupadenant HCl to use with carboplatin and pemetrexed. In the second part, they will compare the effects of the drug combination to a placebo, which is a substance with no active medication, to see if the combination is more effective.

Participants in the study will take the medications in capsule form by mouth. The study will monitor the participants over a period to observe any side effects and to measure how the cancer responds to the treatment. The goal is to find out if this new combination of drugs can help control the cancer and improve the quality of life for patients with this type of lung cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving the medication inupadenant hydrochloride and the other receiving a placebo. Both groups will also receive standard chemotherapy drugs, carboplatin and pemetrexed.

  2. Step 2

    Medication administration

    The patient will take inupadenant hydrochloride or a placebo orally in the form of a capsule. The specific dosage and frequency will be determined during the study's initial phase, known as the dose-finding phase.

    In addition to the study medication, the patient will receive carboplatin and pemetrexed as part of their treatment regimen. These medications are standard chemotherapy drugs used to treat lung cancer.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will undergo regular monitoring to assess the safety and effectiveness of the treatment. This includes checking for any side effects or adverse reactions to the medications.

    The patient's response to the treatment will be evaluated using imaging tests to measure the size of the cancer and determine if it is responding to the treatment.

  4. Step 4

    Study duration

    The study is expected to continue until April 2027. During this time, the patient will continue to receive the assigned treatment and participate in regular assessments as outlined in the study protocol.

Who can join the trial?

12 criteria

  • Must have signed a form that shows you agree to participate in the study, approved by a special ethics committee.
  • Must be **18 years or older** at the time of signing the consent form.
  • Must have a confirmed diagnosis of **nonsquamous non-small cell lung cancer** that is either spread to other parts of the body (Stage IV) or is advanced and cannot be removed by surgery (Stage III), and has come back or gotten worse.
  • Must have a disease that can be measured using specific criteria, with at least one area of the disease that has not been treated with radiation before.
  • Must have information about **PD-L1 expression status** available before joining the study. PD-L1 is a protein that can affect the immune system's response to cancer.
  • Must be able to provide a sample of the tumor from a previous biopsy done within the last 4 years, or have a tumor that can be safely biopsied again.
  • Must have had the cancer come back or get worse after receiving a specific type of therapy called **anti-PD-1/PD-L1 therapy**. This therapy helps the immune system fight cancer. Specific conditions apply based on previous treatments.
  • Must have adequate organ function, confirmed by recent lab tests. This includes:
    • Enough white blood cells and platelets, and a certain level of hemoglobin without recent blood transfusions.
    • Good kidney function, measured by a test called **glomerular filtration rate**.
    • Normal liver function, with specific levels of bilirubin and liver enzymes.
    • Normal blood clotting ability, unless taking medication that affects clotting.
    • Must have a performance status of 0 or 1 on the **Eastern Cooperative Oncology Group (ECOG) scale**, which means you are fully active or have some symptoms but can still carry out light work.

Who cannot join the trial?

5 criteria

  • Patients with a different type of lung cancer than nonsquamous non-small cell lung cancer cannot participate. This type of cancer is a specific form of lung cancer that does not involve squamous cells, which are flat cells found in the lining of the airways.
  • Patients who have not been diagnosed with nonsquamous non-small cell lung cancer are excluded.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to safely receive the study medications, carboplatin and pemetrexed, are excluded. These are chemotherapy drugs used to treat cancer.
  • Patients who are part of a vulnerable population that the study cannot safely include are excluded. This means people who might be at higher risk of harm from participating in the study.
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Investigated drugs

  • Inupadenant

    is an investigational medication being studied for its potential to treat nonsquamous non-small cell lung cancer. In this trial, it is being tested in combination with other cancer treatments to determine its safety, tolerability, and effectiveness. The goal is to find the best dose to use in further studies.

  • Carboplatin

    is a chemotherapy drug used to treat various types of cancer, including lung cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, carboplatin is used in combination with other treatments to assess its effectiveness in patients who have not responded to previous immunotherapy.

  • Pemetrexed

    is another chemotherapy medication used to treat lung cancer. It targets and disrupts the growth of cancer cells by interfering with their ability to use folic acid, which is necessary for cell division. In this study, pemetrexed is combined with other treatments to evaluate its role in improving patient outcomes.

What is already known about the treatment

Inupadenant – Inupadenant is administered orally and is currently being studied in clinical trials for its potential use in treating nonsquamous non-small cell lung cancer, particularly in patients who have not responded to immunotherapy. It is in the experimental phase, with ongoing research to determine its safety and effectiveness. The medication works by targeting specific molecular pathways involved in cancer cell growth, aiming to inhibit tumor progression. Inupadenant is classified as an investigational drug, and its exact mechanism of action is still under study, focusing on its potential to enhance the effects of chemotherapy agents like carboplatin and pemetrexed.

Investigated diseases

Nonsquamous non-small cell lung cancer – This is a type of lung cancer that originates in the tissues of the lung, specifically in cells that are not squamous cells. It is one of the most common types of lung cancer and includes subtypes such as adenocarcinoma and large cell carcinoma. The disease typically progresses by forming tumors in the lungs, which can grow and spread to other parts of the body. As the cancer advances, it may cause symptoms like persistent cough, chest pain, and difficulty breathing. The progression can vary greatly among individuals, with some experiencing slow growth and others facing rapid advancement. Understanding the specific subtype and stage of the cancer is crucial for determining its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515393-27-00Protocol codeA2A-005Estimated enrolment186 patientsSponsoriTeos Belgium

sourced from the EU Clinical Trials Register and site verification

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