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Study of Tuvusertib and Cemiplimab for Patients with Non-Squamous Non-Small Cell Lung Cancer After Previous Treatments

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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-Squamous Non-Small Cell Lung Cancer (NSCLC). The study is testing a combination of two treatments: Tuvusertib (also known by its code name M1774) and Cemiplimab. Tuvusertib is a new medication being tested in capsule form, while Cemiplimab is given as a solution for infusion. The purpose of the study is to evaluate how effective and safe these treatments are when used together in patients whose cancer has progressed despite previous treatments.

Participants in the study will receive the combination of Tuvusertib and Cemiplimab. The study is divided into two phases. In the first phase, researchers will focus on finding the best dose of Tuvusertib to use with Cemiplimab. In the second phase, they will look at how well the combination works in treating the cancer. Throughout the study, researchers will monitor participants for any side effects and how well the cancer responds to the treatment.

The study will involve regular check-ups and assessments to track the progress of the treatment. Participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on the effectiveness of the treatment. The study aims to provide valuable insights into the potential benefits of combining Tuvusertib and Cemiplimab for treating Non-Squamous Non-Small Cell 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, participation begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility criteria include being 18 years or older, having a confirmed diagnosis of non-squamous non-small cell lung cancer, and having experienced disease progression after specific prior treatments.

  2. Step 2

    Phase 1b treatment

    The first phase involves receiving a combination of two medications: cemiplimab and Tuvusertib (M1774). Cemiplimab is administered as a solution for infusion, while Tuvusertib is taken orally in the form of hard capsules.

    The purpose of this phase is to evaluate the safety and effectiveness of the treatment combination and to determine the appropriate dosage for the next phase.

  3. Step 3

    Monitoring and assessment

    Throughout the treatment, regular monitoring is conducted to assess the response to the medication and to identify any side effects. This includes physical examinations, imaging tests, and laboratory tests.

    The primary focus is on measuring the overall response to the treatment and identifying any adverse events.

  4. Step 4

    Phase 2a treatment

    In the second phase, the treatment continues with the same combination of cemiplimab and Tuvusertib, using the dosage regimen determined in phase 1b.

    This phase aims to further assess the effectiveness of the treatment in terms of response duration and survival rates.

  5. Step 5

    Ongoing evaluation

    Participants continue to be evaluated for treatment response and any side effects. This includes ongoing assessments of disease progression and overall survival.

    The study is expected to continue until October 2025, with regular follow-ups to monitor long-term outcomes.

Who can join the trial?

12 criteria

  • Must be 18 years or older at the time of signing the consent form.
  • Must have a diagnosis of Non-Squamous Non-Small Cell Lung Cancer confirmed by a doctor.
  • Must have proof of disease getting worse during or after certain treatments:
    • Only one previous treatment with a type of medicine called anti-PD-(L)1 for advanced cancer.
    • Must have had platinum-based therapy for advanced cancer, either with or after anti-PD-(L)1 therapy. If this treatment was given before surgery or to shrink the tumor, the disease must have worsened within 6 months after the last dose.
    • Must have had a response of stable disease or better with anti-PD-(L)1 therapy.
    • The disease must have worsened while on anti-PD-(L)1 therapy or within 16 weeks after the last dose.
    • Must have a measurable disease as determined by the doctor using specific guidelines.
    • Must have an ECOG Performance Status of 0 or 1, which means the patient is fully active or has some symptoms but can still do light work.
    • Must have adequate blood, liver, and kidney function as defined in the study protocol.
    • Must have available tumor tissue samples or have had a specific genetic test done in a certified lab, and the PD-L1 status must be known.
    • For the Phase 2a part only: Must have a liquid biopsy to check for specific tumor changes, and participants will be placed in different groups based on the results.
    • Other criteria defined in the study protocol may also apply.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer besides Non-Squamous Non-Small Cell Lung Cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or take the study medications cannot participate.
  • Patients with certain medical 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.
  • Patients with a history of severe allergic reactions to the study medications cannot participate.
  • Patients with uncontrolled medical conditions that could affect their safety during the study cannot participate.
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Investigated drugs

  • Tuvusertib (M1774)

    is an experimental medication being studied for its potential to treat non-squamous non-small cell lung cancer. It works by inhibiting a specific protein called ATR, which is involved in the repair of damaged DNA in cancer cells. By blocking this protein, Tuvusertib may help to prevent cancer cells from repairing themselves, potentially leading to their death and slowing the progression of the cancer.

  • Cemiplimab

    is a medication used in cancer treatment that helps the immune system recognize and attack cancer cells. It is a type of immunotherapy known as a PD-1 inhibitor. By blocking the PD-1 pathway, cemiplimab can enhance the body's immune response against cancer cells, which may help to slow down or stop the growth of the cancer.

What is already known about the treatment

  • Tuvusertib

    Tuvusertib is administered orally and is currently being studied in clinical trials for its potential use in treating non-squamous non-small cell lung cancer. It is in the investigational stage and is not yet approved for general medical use. The main therapeutic indication is for patients whose cancer has progressed despite prior treatments with anti-PD-(L)1 and platinum-based therapies. Tuvusertib works by inhibiting ATR, a protein involved in DNA damage repair, which may enhance the effectiveness of other cancer treatments. It is classified as an ATR inhibitor in pharmacology.

  • Cemiplimab

    Cemiplimab is administered via intravenous infusion and is an approved medication used in the treatment of certain types of cancer, including non-squamous non-small cell lung cancer. It is currently being evaluated in combination with Tuvusertib in clinical trials. The main therapeutic indication is for patients whose cancer has progressed after previous treatments. Cemiplimab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as a PD-1 inhibitor in pharmacology.

Investigated diseases

Non-Squamous Non-Small Cell Lung Cancer – This is a type of lung cancer that originates in the tissues of the lung, specifically in cells that are not squamous in nature. It is one of the most common types of lung cancer and includes subtypes such as adenocarcinoma and large cell carcinoma. The disease typically begins in the outer parts of the lungs and may not cause symptoms until it has progressed. As it advances, it can spread to other parts of the body, including the lymph nodes and other organs. Symptoms may include a persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some cases growing slowly while others may advance more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502010-85-00Protocol codeMS201924_0022Estimated enrolment255 patientsSponsorMerck Healthcare KGaA

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).