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Study on THIO and Cemiplimab for Patients with Advanced Non-Small Cell Lung Cancer

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 Non-Small Cell Lung Cancer (NSCLC). The study is evaluating the effects of two treatments: THIO and Cemiplimab (LIBTAYO®). THIO is a specially designed chemical compound, while Cemiplimab is a type of protein-based medication. The purpose of the study is to determine how safe and effective these treatments are when used together in patients with advanced NSCLC.

Participants in the study will receive the treatments in a specific order, starting with THIO followed by Cemiplimab. Both medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. The study will monitor participants over a period of time to observe any side effects and to see how well the cancer responds to the treatment.

The study aims to gather information on the safety of the treatment combination and its ability to control the cancer. Researchers will look at how the cancer responds to the treatment, including whether it shrinks or stops growing. The study will also track any side effects that occur and how severe they are. This information will help determine if the treatment is a viable option for people with advanced NSCLC.

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

    The study begins with the administration of THIO, a medication given to patients with advanced non-small cell lung cancer. This medication is provided in a specific sequence with another drug called cemiplimab.

    THIO is administered through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The exact dosage and frequency are determined by the study protocol and the patient's specific condition.

  2. Step 2

    Subsequent treatment phase

    Following the initial administration of THIO, the patient will receive cemiplimab (also known as LIBTAYO). This medication is also given as an intravenous infusion.

    Cemiplimab is administered to evaluate its safety and effectiveness when used after THIO. The dosage is 350 mg, and the frequency of administration is determined by the study protocol.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, the patient's response to the treatment is closely monitored. This includes regular assessments to determine the safety and tolerability of the medications.

    The study aims to evaluate the overall response rate, which includes measuring any complete or partial responses to the treatment, as well as the disease control rate, which considers stable disease conditions.

  4. Step 4

    Completion and follow-up

    Upon completion of the treatment phases, patients will undergo follow-up assessments to monitor long-term effects and overall survival.

    The study is expected to conclude by November 2025, with ongoing evaluations to ensure patient safety and gather comprehensive data on the treatment's efficacy.

Who can join the trial?

12 criteria

  • Must be at least 18 years old.
  • Women who can have children must agree to use a very effective form of birth control and not donate eggs during the study and for 6 months after the last dose of the study drug.
  • Men and their female partners who can have children should use a combination of birth control methods and a male condom during the study and for 6 months after the last dose of the study drug. Men should also not donate sperm during this time.
  • Must be able to give written consent to participate in the study, agreeing to follow the study's rules and restrictions.
  • Must have advanced Non-Small Cell Lung Cancer (NSCLC) that is either Stage 3 or Stage 4 and has worsened or returned after previous treatment. Stage 4 patients must have worsened or returned after the first treatment. Stage 3 patients must have failed or be unable to receive local treatments like surgery or chemoradiation. Patients with certain types of resistance to treatment are not eligible.
  • Must have had only one previous treatment for advanced NSCLC, which included a specific type of drug called anti-PD-1/PD-L1, and the cancer must have shown signs of worsening on or after this treatment. Previous treatment with anti-PD-1/PD-L1 could have been alone or with other treatments like chemotherapy. Previous platinum-based chemotherapy is not required. Patients who received more than one type of immune checkpoint inhibitor (ICI) are not eligible.
  • Must have at least one measurable area of cancer that can be tracked during the study.
  • If available, a sample of the cancer tissue must be provided. If not available, approval from the Medical Monitor is needed.
  • Must have a performance status of 0-1 according to the Eastern Cooperative Oncology Group (ECOG), which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have adequate organ function, which includes specific levels of blood cells, liver function, and kidney function as determined by laboratory tests.
  • Women who can have children must have a negative pregnancy test before receiving the first dose of the study drug.
  • Use of birth control by men or women should follow local regulations for clinical studies.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than Non-Small Cell Lung Cancer (NSCLC) cannot participate. NSCLC is a common type of lung cancer.
  • 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 follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.
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Investigated drugs

  • THIO

    is a medication being studied for its potential to treat advanced non-small cell lung cancer (NSCLC). It is being evaluated to understand how safe and tolerable it is for patients, as well as how effective it might be when used in combination with another medication.

  • Cemiplimab (LIBTAYO®)

    is a medication that is already used to treat certain types of cancer. In this study, it is being used in combination with THIO to see if the two medications together can provide better outcomes for patients with advanced non-small cell lung cancer.

What is already known about the treatment

  • THIO

    THIO is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced non-small cell lung cancer (NSCLC). It is in the experimental phase, with ongoing research to determine its safety and effectiveness when used in combination with cemiplimab. THIO works by targeting specific molecular pathways involved in cancer cell growth, aiming to disrupt these processes and inhibit tumor progression. It is classified as an investigational anticancer agent.

  • Cemiplimab (LIBTAYO®)

    Cemiplimab is administered via intravenous infusion and is an approved medication used in the treatment of certain types of cancer, including advanced non-small cell lung cancer. It is a monoclonal antibody that works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. Cemiplimab is classified as an immune checkpoint inhibitor and is being studied in combination with THIO to evaluate its safety and efficacy in treating NSCLC.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms. The progression of the disease can vary greatly among individuals, depending on factors like the specific subtype and stage at diagnosis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504595-26-00Protocol codeTHIO-101Estimated enrolment292 patientsSponsorMaia Biotechnology Inc.

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