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Study Comparing ONC-392 and Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After PD-1/PD-L1 Inhibitor Treatment

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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 Metastatic Non-Small Cell Lung Cancer (NSCLC). This is a condition where cancer cells from the lung have spread to other parts of the body. The study is comparing two treatments: a new drug called ONC-392 and a standard chemotherapy drug known as Docetaxel. ONC-392 is a special type of protein called a humanised IgG1 monoclonal antibody that targets a specific part of the immune system, while Docetaxel is a chemical used to kill cancer cells.

The purpose of this study is to see how well ONC-392 works compared to Docetaxel in patients whose cancer has continued to grow despite previous treatments with other cancer drugs called PD-1/PD-L1 inhibitors. These inhibitors are a type of immunotherapy that helps the immune system fight cancer. The study will involve patients receiving either ONC-392 or Docetaxel, and their health will be monitored over a period of time to see which treatment helps them live longer.

Participants in the study will receive their assigned treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last up to 52 weeks, during which time doctors will check the patients' response to the treatment and any side effects they might experience. The main goal is to determine which treatment is more effective in improving the overall survival of patients with this type of lung cancer.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the study drug ONC-392 or the standard treatment docetaxel. This is to compare the effectiveness of the two treatments.

  2. Step 2

    Treatment administration

    If you are assigned to the ONC-392 group, you will receive the medication through an intravenous infusion. The specific dosage and frequency will be explained to you by the medical team.

    If you are assigned to the docetaxel group, you will also receive the medication through an intravenous infusion. The dosage and frequency will be determined by the medical team based on your individual needs.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring will be conducted to assess your health and the effectiveness of the treatment. This will include physical examinations, blood tests, and imaging studies to evaluate the size and progression of the tumor.

    You will be asked to report any side effects or changes in your health to the study team. This information is crucial for ensuring your safety and the success of the study.

  4. Step 4

    Follow-up visits

    You will have scheduled follow-up visits with the study team. These visits are important for tracking your progress and making any necessary adjustments to your treatment plan.

    During these visits, the study team will discuss your overall health, any side effects you may be experiencing, and the results of any tests or assessments.

  5. Step 5

    End of study participation

    At the end of your participation in the study, a final assessment will be conducted. This will include a comprehensive evaluation of your health and the outcomes of the treatment.

    The study team will provide you with information on any further steps or treatments that may be necessary after the study concludes.

Who can join the trial?

8 criteria

  • Must be an adult (18 years or older) of any gender and able to sign a consent form.
  • Must have a confirmed diagnosis of metastatic Non-Small Cell Lung Cancer (NSCLC). This means the cancer has spread to other parts of the body.
  • Must have shown cancer progression after previous treatments, which include:
    • At least 12 weeks of treatment with a combination of PD-1/PD-L1 inhibitors and platinum-based chemotherapy.
    • At least 2 cycles of platinum-based chemotherapy, followed by at least 12 weeks of PD-1 or PD-L1 inhibitor-based immunotherapy. Other treatments like antibodies against CTLA-4, LAG-3, TIGIT, VEGF, or VEGFR in combination with PD-1/PD-L1 inhibitors are allowed.
    • Must have at least one measurable tumor lesion as confirmed by a specific review process.
    • Must have an ECOG score of 0 or 1. This score measures the ability to 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 adequate organ functions and a serum LDH level that is less than or equal to 2 times the upper limit of normal (2xULN).
    • Must have a life expectancy of at least 3 months.

Who cannot join the trial?

3 criteria

  • Patients who have a different type of cancer than Metastatic Non-Small Cell Lung Cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • ONC-392

    is an experimental medication being tested in this clinical trial. It is designed to help treat a type of lung cancer called metastatic non-small cell lung cancer. This medication is being studied to see if it can help patients live longer after their cancer has progressed despite previous treatments with certain immune therapies known as PD-1/PD-L1 inhibitors. The goal is to determine if ONC-392 can improve overall survival for these patients.

  • Docetaxel

    is a medication that is already used to treat various types of cancer, including lung cancer. It works by interfering with the growth and spread of cancer cells in the body. In this trial, docetaxel is being used as a comparison to the experimental medication ONC-392. Researchers want to see how well ONC-392 performs in comparison to docetaxel in terms of helping patients with metastatic non-small cell lung cancer live longer.

What is already known about the treatment

  • ONC-392

    ONC-392 is administered as an injection, typically given by a healthcare professional. It is currently being studied in clinical trials for its effectiveness in treating metastatic non-small cell lung cancer, especially in cases where the cancer has progressed despite previous treatments with PD-1/PD-L1 inhibitors. The medication works by targeting specific proteins on cancer cells, helping the immune system to better recognize and attack these cells. ONC-392 is classified as an immunotherapy drug, which means it helps the body's immune system fight cancer.

  • Docetaxel

    Docetaxel is given as an intravenous infusion, usually in a hospital or clinic setting. It is a well-established chemotherapy drug used to treat various types of cancer, including metastatic non-small cell lung cancer. Docetaxel works by interfering with the growth and division of cancer cells, ultimately leading to their death. It belongs to a class of drugs known as taxanes, which are used to disrupt the microtubule structures within the cell, preventing cancer cells from multiplying.

Investigated diseases

Metastatic Non-Small Cell Lung Cancer – This disease is a type of lung cancer that begins in the cells of the lungs and has spread to other parts of the body. It is characterized by the uncontrolled growth of abnormal cells in the lung tissue, which can form tumors. As the disease progresses, these cancerous cells can invade nearby tissues and organs, leading to further complications. The spread of cancer to distant organs is known as metastasis, which can significantly impact the function of affected organs. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower progression. The disease is often categorized by the type of cells involved, such as adenocarcinoma, squamous cell carcinoma, or large cell carcinoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505311-20-01Protocol codePRESERVE-003Estimated enrolment584 patientsSponsorOncoc4 Inc.

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