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

Verified siteRegistered drugNo placebo
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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 form of cancer that has spread from the lungs to other parts of the body. The study is comparing two treatments: ONC-392 and Docetaxel. ONC-392 is a special type of medicine called a humanised IgG1 monoclonal antibody, which is designed to target specific proteins in the body. Docetaxel is a well-known chemotherapy drug used to treat various cancers.

The purpose of this study is to see how effective ONC-392 is compared to Docetaxel in helping patients live longer. Participants in the study will be randomly assigned to receive either ONC-392 or Docetaxel. The study will take place over a period of time, during which patients will receive their assigned treatment and be monitored regularly. The study aims to understand which treatment helps patients live longer and how each treatment affects the cancer's progression.

Throughout the study, doctors will also look at how the cancer responds to the treatments and any side effects that may occur. This information will help determine the best treatment options for patients with Metastatic Non-Small Cell Lung Cancer who have previously been treated with other cancer therapies. The study is designed to provide valuable insights into the effectiveness and safety of these treatments for this specific 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, eligibility is confirmed based on specific criteria such as age, diagnosis of metastatic non-small cell lung cancer, and previous treatments.

    Informed consent is required, indicating understanding and agreement to participate.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either ONC-392 or docetaxel treatment.

    This process ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment administration

    For those receiving docetaxel, it is administered as a concentrate for solution for infusion, typically through an intravenous infusion.

    The dosage and frequency of administration are determined by the study protocol and medical team.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment and any side effects.

    Assessments include measuring overall survival, response rate, and progression-free survival.

  5. Step 5

    End of treatment

    The treatment continues until the study's end date or until it is deemed necessary to discontinue for medical reasons.

    Participants are informed about the results and any further steps 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 nearby lymph nodes or other parts of the body.
  • Must have shown cancer progression on scans after recent treatment. This treatment should include:
    • At least 12 weeks of a PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy.
    • Or, at least 2 cycles of platinum-based chemotherapy followed by at least 12 weeks of PD-1 or PD-L1 inhibitor-based immunotherapy. Other specific antibodies can be used with PD-1/PD-L1 inhibitors.
    • Must have at least one tumor that can be measured using a standard method called RECIST 1.1.
    • Must have an ECOG score of 0 or 1, which indicates the level of daily functioning. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
    • Must have adequate organ function, with a serum LDH level that is no more than twice the upper limit of normal. LDH is a substance in the blood that can indicate tissue damage.
    • 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. This type of cancer has spread from the lungs to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.
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Investigated drugs

  • ONC-392

    is an experimental medication being studied for its potential to treat metastatic non-small cell lung cancer. It is being compared to another treatment to see if it can help patients live longer after their cancer has progressed despite previous treatments with PD-1/PD-L1 inhibitors.

  • Docetaxel

    is a chemotherapy medication commonly used to treat various types of cancer, including lung cancer. In this trial, it serves as a standard treatment option to compare the effectiveness of the experimental medication ONC-392.

What is already known about the treatment

  • ONC-392

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic non-small cell lung cancer, particularly in cases where the cancer has progressed after treatment with PD-1/PD-L1 inhibitors. It is in the experimental phase and is not yet widely recognized in medical literature as a standard treatment. ONC-392 works by targeting specific pathways in cancer cells to inhibit their growth and survival. It is classified as an immunotherapy agent, aiming to enhance the body's immune response against cancer cells.

  • Docetaxel

    This medication is given through an intravenous infusion and is an established treatment for various types of cancer, including metastatic non-small cell lung cancer. It is well-documented in medical literature and is commonly used when other treatments, such as PD-1/PD-L1 inhibitors, are no longer effective. Docetaxel works by disrupting the microtubule structures within cancer cells, which are essential for cell division, thereby inhibiting their growth. It is classified as a chemotherapy drug, specifically a taxane, and is used to slow or stop the growth of cancer cells.

Investigated diseases

Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and has spread to other parts of the body. It is the most common form of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors in the lungs, which can then metastasize to other organs such as the brain, bones, or liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the cancer spreads, it can lead to more severe symptoms and complications. The progression of the disease can vary greatly among individuals, depending on factors like the cancer's genetic makeup and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505311-20-00Protocol codePRESERVE-003Estimated enrolment575 patientsSponsorOncoc4 Inc.

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