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Study of N-803, tislelizumab and docetaxel combination versus docetaxel alone for patients with advanced or metastatic non-small cell lung cancer resistant to immune checkpoint inhibitors

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 study focuses on patients with Advanced or Metastatic Non-Small Cell Lung Cancer who have previously received immunotherapy but their disease has continued to progress. The research evaluates a combination treatment approach using three medications: N-803, tislelizumab, and docetaxel, comparing it to treatment with docetaxel alone. Tislelizumab and N-803 are experimental drugs designed to help the immune system fight cancer cells, while docetaxel is a commonly used chemotherapy medication.

The main purpose of this research is to determine if the combination of these three medications can help patients live longer compared to using docetaxel by itself. The study involves two groups of patients - one receiving all three medications, while the other group receives only docetaxel. The medications are given through different methods: tislelizumab and docetaxel are given through an intravenous infusion (into a vein), while N-803 is given as a subcutaneous injection (under the skin).

During the study, patients will receive treatment and have regular check-ups to monitor their health and how well the treatment is working. The treatment will continue as long as it appears to be helping and the side effects are manageable. Doctors will use special scanning techniques to measure if the tumors are shrinking and will track how long patients live after starting the treatment.

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

    Initial treatment phase

    You will be randomly assigned to one of two treatment groups:

    Group 1: You will receive a combination of three medications: tislelizumab (given through an intravenous infusion), nogapendekin alfa inbakicept (given as a subcutaneous injection), and docetaxel (given through an intravenous infusion)

    Group 2: You will receive only docetaxel through an intravenous infusion

  2. Step 2

    Regular monitoring

    Your doctor will regularly check your health status using imaging scans to measure tumor response

    Blood tests will be performed to monitor your overall health

    Your side effects will be tracked and documented

  3. Step 3

    Treatment continuation

    Treatment will continue as long as your disease does not worsen

    Your doctor will assess if the benefits of continuing treatment outweigh any side effects you may experience

  4. Step 4

    Follow-up period

    After completing treatment, you will need to use effective birth control for 7 months if you are of childbearing age

    Regular check-ups will continue to monitor your health status

    The study is expected to continue until December 31, 2029

Who can join the trial?

12 criteria

  • Must be at least 18 years old
  • Must be able to understand and sign an informed consent form
  • Must have confirmed stage IV non-small cell lung cancer
  • Must have developed resistance to previous immunotherapy treatment after initially responding to it for at least 6 months
  • Must have at least one specific genetic change (EGFR, ROS1, NTRK, BRAF, MET, RET, or KRAS) in their tumor
  • Must have received 1-2 previous targeted treatments that were approved for their specific genetic change
  • For patients with specific EGFR mutations, must have previously received osimertinib treatment
  • Must be able to perform daily activities with some limitations (ECOG status 0-2)
  • Must have tumors that can be measured using standard imaging techniques
  • Must be able to attend all required study visits and follow-up appointments
  • Must agree to use effective birth control methods during the study and for 7 months after completing treatment
  • For patients with HIV, must be on anti-HIV medication with undetectable virus levels in the last 6 months

Who cannot join the trial?

15 criteria

  • History of other types of cancer in the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer)
  • Active brain metastases (cancer that has spread to the brain) that are not treated and stable
  • Previous treatment with immunotherapy for lung cancer
  • Presence of an autoimmune disease (where the body's immune system attacks healthy cells)
  • Use of systemic corticosteroids (medications like prednisone) or other medications that suppress the immune system
  • Active or untreated hepatitis B or C infection
  • Known HIV infection
  • Serious heart conditions in the past 6 months
  • Uncontrolled high blood pressure
  • History of organ transplant
  • Any other serious medical condition that could interfere with study participation
  • Pregnancy or breastfeeding
  • Inability to swallow oral medications
  • Known allergic reactions to study medications
  • Participation in another clinical trial within the past 30 days
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Investigated drugs

  • N-803

    is a biological therapy designed to boost the immune system's ability to fight cancer cells. It works by stimulating certain immune cells to become more active against tumors.

  • Tislelizumab

    is an immunotherapy medication that helps the body's immune system attack cancer cells. It belongs to a group of drugs called checkpoint inhibitors, which work by blocking certain proteins that prevent immune cells from recognizing and destroying cancer cells.

  • Docetaxel

    is a chemotherapy medication used to treat various types of cancer, including non-small cell lung cancer. It works by interfering with the ability of cancer cells to divide and grow, ultimately causing them to die.

What is already known about the treatment

  • Tislelizumab

    A humanized monoclonal antibody administered through intravenous infusion, which works by targeting and blocking the PD-1 receptor on immune cells. This medication belongs to the class of immune checkpoint inhibitors and is primarily used in the treatment of advanced or metastatic non-small cell lung cancer. It helps restore the immune system's ability to detect and fight cancer cells by preventing the cancer cells from evading immune system detection.

  • Docetaxel

    An intravenously administered chemotherapy medication belonging to the taxane family of drugs, which works by disrupting cell division and preventing cancer cells from growing and spreading. This widely-used medication is approved for treating various types of cancer, including advanced non-small cell lung cancer, and functions by binding to and stabilizing microtubules in cancer cells, leading to cell death. It is commonly used as a standard treatment option in both first-line and subsequent therapy settings.

  • N-803

    A novel biological compound administered via subcutaneous injection that acts as an IL-15 superagonist complex, designed to enhance the body's natural immune response against cancer cells. This investigational immunotherapy agent works by stimulating the proliferation and activation of natural killer cells and T cells, potentially improving the body's ability to fight cancer when used in combination with other cancer treatments.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) - A type of lung cancer that begins in the large cells of the lung, including both squamous and non-squamous cells. The disease typically develops slowly and may spread from the lungs to nearby tissues and other parts of the body. In advanced stages, the cancer cells spread (metastasize) to other organs, commonly affecting the bones, liver, or brain. NSCLC accounts for the majority of all lung cancer cases and can cause symptoms such as persistent cough, chest pain, and breathing difficulties. The condition usually progresses through distinct stages, from localized tumors to more extensive spread throughout the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521221-32-00Protocol codeResQ201A-NSCLCEstimated enrolment578 patientsSponsorImmunitybio Inc.

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