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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Institut Gustave Roussy Villejuif France
Centr Georges Francois Leclerc Dijon France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario Hm Sanchinarro Madrid Spain
IRCCS Humanitas Research Hospital Rozzano Italy
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Farkasgyepui Tudogyogyintezet Farkasgyepu Hungary
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Jessa Ziekenhuis Hasselt Belgium
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Radiotherapy Center Cluj S.R.L. Floresti Romania
Spitalul Municipal Ploiesti Ploiesti Romania
Virgen del Rocío University Hospital Sevilla Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Clinexpert Kft. Budapest Hungary
University Of Pecs Pecs Hungary
Institut de Cancérologie de l’Ouest Saint-Herblain France
Hospital Universitario Virgen De La Victoria Malaga Spain
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Oegvhnpscsfquq Lcoy Glzh Linz Austria
Hsdskmqc Vbel dabusbrt Barcelona Spain
Iclvdlzb Pkiiltltbgvvnne Cpdvnz Cfpdck Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
30.05.2024
Belgium Belgium
Not yet recruiting
30.05.2024
France France
Not yet recruiting
30.05.2024
Hungary Hungary
Not yet recruiting
30.05.2024
Italy Italy
Not yet recruiting
30.05.2024
Romania Romania
Not yet recruiting
30.05.2024
Spain Spain
Not yet recruiting
30.05.2024

Trial locations

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.

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 ID:
2023-508730-34-00
Protocol code:
SPLFIO-174
NCT ID:
NCT06162572
Trial Phase:
Human Pharmacology (Phase I) – Other

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