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Study of THIO and cemiplimab compared to chemotherapy in patients with advanced non-small cell lung cancer who have received two previous treatments

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 (NSCLC) who have already received two previous treatments. The study compares two different treatment approaches. The first approach uses a combination of two medications: THIO followed by cemiplimab (also known as LIBTAYO). The second approach uses one of several standard chemotherapy medications: gemcitabine, vinorelbine, or docetaxel.

The purpose of this research is to determine if using THIO followed by cemiplimab helps patients with advanced NSCLC live longer compared to using standard chemotherapy alone. Both treatments are given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.

During the study, patients will be randomly assigned to receive either the THIO/cemiplimab combination or one of the standard chemotherapy medications. The treatment period may continue for up to 24 months. Throughout the study, doctors will monitor patients' health and track how their cancer responds to the treatment. They will also watch for any side effects that may occur during the treatment period.

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

    Initial evaluation

    Your eligibility will be confirmed through medical tests up to 14 days before starting treatment

    Laboratory tests will check your bone marrow function, liver function, and kidney function

    If you are a woman who can become pregnant, a pregnancy test will be required within 72 hours before starting treatment

  2. Step 2

    Treatment assignment

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

    Group 1: THIO followed by cemiplimab (LIBTAYO®) treatment

    Group 2: Single chemotherapy medicine chosen by your doctor (either gemcitabine, vinorelbine, or docetaxel)

  3. Step 3

    Treatment administration

    All medications will be given through an intravenous (IV) infusion (directly into your vein)

    Your treatment will continue until either your disease progresses or you experience unacceptable side effects

    Regular assessments will monitor your response to treatment and any side effects

  4. Step 4

    Follow-up period

    Your health will be monitored throughout the study period

    The study will track how long you live without your disease getting worse (progression-free survival)

    The study will continue until 2028

  5. Step 5

    Safety monitoring

    Throughout the study, you will be monitored for side effects

    Any serious side effects or reactions that lead to stopping treatment will be recorded

    Regular medical examinations and laboratory tests will be performed to ensure your safety

Who can join the trial?

13 criteria

  • Must be at least 18 years of age
  • Must have adequate organ function including: - Proper bone marrow function (specific blood cell counts) - Normal liver function (within specified limits) - Healthy kidney function (specific creatinine clearance levels)
  • Women who can become pregnant must have a negative pregnancy test within 72 hours before starting treatment
  • Must agree to use effective birth control methods during the study and for 6 months after the last treatment: - Applies to women who can become pregnant - Applies to male participants and their female partners - Men must also avoid sperm donation during this period
  • Must be willing and able to provide informed consent
  • Must have Stage 3b or 4 Non-Small Cell Lung Cancer (confirmed by tissue or cell examination)
  • Must have received two previous treatments for advanced cancer, including: - Immunotherapy (anti-PD-1/PD-L1) - Platinum-based chemotherapy
  • Must show that previous treatment was not effective or could not be tolerated
  • Must have documented resistance to previous immunotherapy treatment
  • Must not have received previous targeted therapy for genetic mutations
  • Must have at least one measurable tumor that can be tracked during the study
  • Must provide a tissue sample from previous biopsies if available
  • Must have good physical function ability (ECOG performance status of 0-1, meaning able to perform daily activities with minimal assistance)

Who cannot join the trial?

13 criteria

  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Previous treatment with cemiplimab (a type of immunotherapy drug)
  • Known allergies to the study medications
  • Severe heart conditions or uncontrolled high blood pressure
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Other types of cancer within the last 3 years (except for successfully treated skin cancer or early-stage cancer)
  • Autoimmune diseases requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • Severe lung disease or breathing problems
  • Pregnancy or breastfeeding
  • Use of systemic steroids or other immunosuppressive medications (drugs that weaken the immune system)
  • Major surgery within 4 weeks before starting the study
  • Participation in other clinical trials within 4 weeks before this study
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

  • THIO

    is an investigational drug being studied for the treatment of advanced non-small cell lung cancer. It is designed to be used as part of a third-line treatment approach for patients whose cancer has progressed after previous treatments.

  • Cemiplimab

    (also known as LIBTAYO) is an immunotherapy medication that helps the body's immune system recognize and fight cancer cells. It works by targeting and blocking a protein called PD-1, which can help the immune system better attack cancer cells.

  • Single-agent Chemotherapy

    refers to traditional cancer treatments that use one chemotherapy drug to kill cancer cells or stop them from growing. In this trial, the specific chemotherapy medication is chosen by the treating physician from available options.

What is already known about the treatment

  • Cemiplimab (LIBTAYO)

    A monoclonal antibody medication administered through intravenous infusion, which has been approved for treating advanced non-small cell lung cancer (NSCLC). This immunotherapy drug works by blocking PD-1 protein on immune cells, helping the body's immune system to better recognize and attack cancer cells. Cemiplimab belongs to the class of checkpoint inhibitor immunotherapies and is currently used as a treatment option for patients who have progressed after previous lines of therapy.

  • THIO

    An investigational therapeutic agent being studied in clinical trials for advanced non-small cell lung cancer treatment, specifically in sequence with cemiplimab. This drug is being evaluated as a third-line treatment option for patients with advanced or metastatic NSCLC, though its specific mechanism of action and administration method are still under investigation through clinical trials. THIO represents a novel approach in cancer treatment strategy, being tested in combination with immunotherapy for potentially improved patient outcomes.

Investigated diseases

Non-Small Cell Lung Cancer – A type of lung cancer that begins in the cells of the lungs and gradually forms tumors. It develops when healthy cells in the lung tissue begin to grow uncontrollably and form masses. The disease typically starts in the cells that line the airways of the lungs. It is characterized by the growth and spread of abnormal cells in the lung tissue, which can affect breathing and other bodily functions. The disease can progress from early stages where it is confined to the lungs to more advanced stages where it may spread to nearby tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520164-33-00Protocol codeTHIO-104Estimated enrolment282 patientsSponsorMaia Biotechnology Inc.

sourced from the EU Clinical Trials Register and site verification

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