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Study of SYM024, SYM023, and SYM025 in Adults with Advanced Non-Small Cell Lung Cancer (NSCLC) with High PD-L1 Expression

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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 treatments for advanced non-small cell lung cancer (NSCLC), a type of lung cancer that is either locally advanced or has spread to other parts of the body. The study will explore new combinations of treatments to see how safe and effective they are for people who have not received prior treatment for this condition. The treatments being tested include several investigational drugs: SYM024 (also known as S095024), SYM023 (S095018), and SYM025 (S095029), all of which are given as a solution for infusion, meaning they are administered directly into the bloodstream through a vein. Additionally, a medication called cemiplimab, marketed as LIBTAYO, will be used as a control treatment in the study.

The purpose of the study is to evaluate the safety and effectiveness of these treatment combinations in patients with high levels of a protein called PD-L1 in their tumors. The study will be conducted in two parts. The first part will focus on assessing the safety of the treatment combinations and determining the appropriate dose for further testing. The second part will compare the effectiveness of the treatment combinations against cemiplimab alone. Participants will receive their assigned treatments and be monitored for any side effects and how well their cancer responds to the treatment.

Throughout the study, participants will undergo regular health checks, including blood tests and other assessments, to ensure their safety and to track the progress of their treatment. The study aims to provide valuable information on new treatment options for people with advanced NSCLC, potentially leading to better outcomes for patients in the future.

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, type of lung cancer, and previous treatments.

    Participants must have advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression.

  2. Step 2

    Part a: combination therapy safety lead-in

    This phase evaluates the safety and tolerability of different drug combinations.

    Participants receive medications intravenously, including sym024, sym023, sym025, and cemiplimab.

    The focus is on identifying any dose-limiting toxicities and adverse events during the first two cycles of treatment.

  3. Step 3

    Part b: randomized dose expansion

    This phase assesses the effectiveness of the drug combinations compared to cemiplimab alone.

    Participants continue to receive the medications intravenously.

    The objective is to measure the response to treatment and monitor any adverse events.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular assessments are conducted to monitor the participant's health and response to treatment.

    These assessments include laboratory tests, electrocardiograms (ECGs), and vital sign checks.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by April 2027.

    Final evaluations will determine the overall effectiveness and safety of the treatment combinations.

Who can join the trial?

7 criteria

  • The patient must have **non-small cell lung cancer (NSCLC)**, which is a type of lung cancer. It can be either locally advanced, meaning it has spread within the lungs but not to other parts of the body, or metastatic, meaning it has spread to other parts of the body.
  • The cancer must be confirmed through a test called a **histological** or **cytological** examination, which involves looking at cells under a microscope.
  • The patient should not have received any previous treatment that affects the whole body (systemic treatment) for their advanced or metastatic NSCLC.
  • The cancer cells must show high levels of a protein called **PD-L1**. This is measured by a test that gives a **Tumor Proportion Score (TPS)** of 50% or higher.
  • The patient must be an adult, which means they need to be at least 18 years old.
  • The patient should have a good general health status, which is measured by a scale called the **Eastern Cooperative Oncology Group (ECOG) Performance Status**. A score of 0 means fully active, and a score of 1 means some symptoms but still able to do light work.
  • The patient must have a disease that can be measured using a specific set of guidelines called **RECIST v1.1**. This means the cancer can be seen and measured on scans or tests.

Who cannot join the trial?

2 criteria

  • Participants who have a type of lung cancer called non-small cell lung cancer (NSCLC) that is locally advanced and cannot be treated with surgery or a combination of chemotherapy and radiation.
  • Participants with metastatic NSCLC, which means the cancer has spread to other parts of the body.
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Investigated drugs

Cemiplimab is an immunotherapy medication used in this trial as a control treatment. It works by helping the immune system recognize and attack cancer cells, specifically in patients with advanced non-small cell lung cancer (NSCLC) that have high levels of PD-L1 expression. This medication is part of a class of drugs known as PD-1 inhibitors, which block a pathway that cancer cells use to hide from the immune system.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer (NSCLC), particularly in patients with high PD-L1 expression. The medication works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. Cemiplimab is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses against cancer.

Investigated diseases

Non-small cell lung cancer (NSCLC) – 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. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, where it has 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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508730-34-00Protocol codeSPLFIO-174Estimated enrolment189 patientsSponsorInstitut De Recherches Internationales Servier IRIS

sourced from the EU Clinical Trials Register and site verification

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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).