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Testing OMTX705 Combined with Carboplatin, Pemetrexed, and Tislelizumab for Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with non-squamous non-small cell lung cancer that has spread to other parts of the body or is advanced. The study will test a combination of medications given directly into the vein. These medications include OMTX705, which is an experimental medicine being tested for the first time in this combination, along with carboplatin, pemetrexed, and tislelizumab. Carboplatin and pemetrexed are chemotherapy drugs that work by stopping cancer cells from growing and dividing. Tislelizumab is a type of immunotherapy that helps the body's immune system recognize and attack cancer cells. OMTX705 is designed to target specific proteins found on certain cells in tumors.

The study is divided into two parts. The first part will test different doses of OMTX705 when combined with the other three medications to find a safe dose that can be used in the second part. During this phase, doctors will carefully monitor patients for any side effects and determine the best dose to use. The second part of the study will compare the combination of all four medications to a treatment that does not include OMTX705. This comparison will help researchers understand if adding OMTX705 to the standard treatment makes the treatment work better.

Throughout the study, participants will have regular check-ups, blood tests, and imaging scans to monitor how the cancer responds to treatment and to check for any side effects. The study aims to find out if this combination of medications is safe and if it can help shrink tumors or slow down the growth of cancer. Researchers will also look at how long patients live without their cancer getting worse and how long they survive overall. Blood samples will be collected to measure the levels of the medications in the body and to check if the body develops any immune response to OMTX705.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase with four medications
Your treatment will begin with a combination of four medications administered through a vein. These medications are OMTX705, tislelizumab, carboplatin, and pemetrexed.
All four medications will be given as infusions, which means they will be delivered directly into your vein over a period of time.
This combination treatment will be given in cycles. The specific dosage and frequency will be determined during the study based on safety observations.
Step 2
Safety monitoring during initial phase
Your health will be closely monitored throughout the treatment to assess safety and tolerability of the medication combination.
Blood samples will be taken regularly to check your blood cell counts, liver function, and kidney function.
Your vital signs, such as blood pressure, heart rate, and temperature, will be measured at each visit.
Any side effects you experience will be recorded and assessed according to their severity and duration.
Step 3
Regular imaging assessments
Imaging scans will be performed at scheduled intervals to evaluate how your cancer is responding to treatment.
These scans may include CT scans (computed tomography), PET/CT scans, or MRI scans (magnetic resonance imaging).
The scans will measure any changes in the size of your tumors to determine if the treatment is working.
Step 4
Blood sample collection for research purposes
Blood samples will be collected at specific times during your treatment to measure the levels of the study medication in your bloodstream.
Additional blood tests will be performed to check if your body develops any immune response to the study medication, specifically looking for anti-drug antibodies.
These samples help researchers understand how the medication behaves in your body.
Step 5
Ongoing treatment cycles
Your treatment will continue in repeating cycles as long as the treatment is beneficial and tolerable for you.
The duration of each cycle and the total number of cycles will be determined based on how your cancer responds and how well you tolerate the treatment.
Your doctor will regularly assess whether you should continue with the treatment or if modifications are needed.
Step 6
Continuous safety evaluation
Throughout the entire study period, any side effects or health changes will be documented and evaluated.
Your blood tests, vital signs, and overall health status will be monitored at each visit.
Any necessary adjustments to your medication doses will be made based on your individual response and tolerance.
Step 7
Long-term follow-up assessments
Your health will be monitored at regular intervals, including assessments at 3, 6, and 12 months, and every 3 months thereafter.
These follow-up visits will track your overall survival and whether your cancer has progressed.
Monitoring will continue for up to 24 months or as specified in the study protocol.

Who can join the trial?

12 criteria

You must be able to understand and sign a consent form that explains the study, and you must agree to follow all study requirements before any study procedures begin.
Women who can become pregnant and men whose partners can become pregnant must agree to use birth control methods during the study.
You must have suitable veins that allow for safe delivery of the study drug and collection of blood samples needed for the study.
You must provide a sample of your tumor tissue that has not been treated with radiation therapy before the sample was taken. The tissue sample should be preserved in formalin, which is a special solution that keeps tissue samples stable. This sample is used to measure a marker called PD-L1, which is a protein on cancer cells.
You must be 18 years of age or older.
You must have a confirmed diagnosis of non-squamous non-small cell lung cancer, which is a specific type of lung cancer. Your cancer must be at stage IV, meaning it has spread to other parts of the body, or stage III if all available local treatments have been tried or are not suitable for you.
Your tumor must be tested for PD-L1 TPS, which measures the amount of PD-L1 protein on your cancer cells. The result can range from 0 to 100 percent.
You must have confirmation that targeted therapy, which is a specific type of cancer treatment aimed at certain genetic changes in cancer cells, is not suitable for you. Your tumor must be tested to show that it does not have certain genetic changes in EGFR or ALK genes, or that it has changes in the RAS gene.
You must have measurable disease, which means your cancer can be seen and measured on imaging scans such as CT scan, which uses X-rays to create detailed pictures, PET/CT scan, which shows how tissues and organs are working, or MRI scan, which uses magnets and radio waves to create images.
You must not have received any previous systemic treatment, which means treatment that travels through the bloodstream to reach cancer cells throughout the body, for your advanced or metastatic lung cancer, meaning cancer that has spread. If you received treatment after surgery or before surgery for earlier stages of cancer, you are eligible only if that treatment was completed at least 6 months before your cancer spread.
You must have an ECOG performance status of 0 or 1. This is a scale that measures how well you can perform daily activities, where 0 means you are fully active and 1 means you have some restrictions but can do light work.
You must have adequate function of your bone marrow, which produces blood cells, your liver, and your kidneys. This includes: total bilirubin, a substance produced by the liver, must be no more than 1.5 times the normal upper limit, or less than 3 times if you have a condition called Gilbert's syndrome; AST and ALT, which are liver enzymes, must be no more than 3 times the normal upper limit, or no more than 5 times if cancer has spread to your liver; your creatinine clearance, which measures kidney function, must be at least 45 milliliters per minute; your hemoglobin, which carries oxygen in your blood, must be at least 9.0 grams per deciliter without blood transfusions in the past 2 weeks; your absolute neutrophil count, a type of white blood cell that fights infection, must be at least 1.5 times 10 to the power of 9 per liter without use of growth factors in the past 2 weeks; your platelet count, which helps blood clot, must be at least 100 times 10 to the power of 9 per liter without platelet transfusions in the past 2 weeks.

Who cannot join the trial?

1 criterion

The study does not list specific exclusion criteria in the provided information. Please consult with the research team at your medical facility to learn about all conditions that may prevent participation in this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Jerez de la Frontera
Verified
Jerez De La Frontera, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

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Investigated drugs

OMTX705
is an experimental medication that is designed to target and attach to a specific protein called fibroblast activation protein, which is found on certain cells in tumors. Once attached, the medication delivers a cancer-fighting drug directly to these cells to help destroy the tumor.
Tislelizumab
is a type of immunotherapy medication that helps your immune system recognize and fight cancer cells. It works by blocking a protein that prevents your immune cells from attacking the tumor, allowing your body's natural defenses to work more effectively against the cancer.
Carboplatin
is a chemotherapy medication that works by damaging the DNA inside cancer cells, which prevents them from growing and dividing. This helps to slow down or stop the spread of cancer in your body.
Pemetrexed
is a chemotherapy medication that blocks certain substances that cancer cells need to grow and multiply. By interfering with these essential building blocks, it helps to stop cancer cells from spreading and growing.

What is already known about the treatment

OMTX705
OMTX705 is an antibody-drug conjugate that specifically targets fibroblast activation protein, a molecule found on certain cells in the tumor environment. This medication is currently being studied in clinical trials for the treatment of advanced or metastatic non-squamous non-small cell lung cancer, which means it has not yet been approved for general medical use. It works by attaching to fibroblast activation protein on cancer-supporting cells and delivering a toxic substance directly to them, helping to destroy the tumor's support structure. In this trial, OMTX705 is being tested in combination with other cancer medications to determine its safety and effectiveness.
Tislelizumab
Tislelizumab is an immunotherapy medication given through injection into a vein that helps the body's immune system recognize and fight cancer cells. It is an approved treatment for various types of cancer and works by blocking a protein called PD-1 on immune cells, which removes the brakes that prevent these cells from attacking tumors. This medication belongs to a class of drugs known as immune checkpoint inhibitors, which have become an important part of modern cancer treatment. In this clinical trial, tislelizumab is being combined with chemotherapy and an experimental drug to treat advanced non-small cell lung cancer.
Carboplatin
Carboplatin is a chemotherapy medication administered through an intravenous infusion that has been widely used for decades to treat various types of cancer, including lung cancer. It works by damaging the DNA inside cancer cells, which prevents them from dividing and growing, ultimately leading to their death. This drug belongs to a class of medications called platinum-based chemotherapy agents and is considered a standard treatment option for many patients with non-small cell lung cancer. Carboplatin is often combined with other cancer medications to improve treatment effectiveness.
Pemetrexed
Pemetrexed is a chemotherapy drug given through a vein that is specifically approved for treating non-squamous non-small cell lung cancer and mesothelioma. It works by blocking several enzymes that cancer cells need to produce DNA and RNA, which are essential building blocks for cell growth and division, thereby stopping cancer cells from multiplying. This medication is classified as an antifolate chemotherapy agent and is commonly used in combination with other drugs like carboplatin as a first-line treatment for lung cancer. Patients receiving pemetrexed typically also take vitamin supplements to reduce side effects.

Investigated diseases

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. The disease develops when cells in the lungs begin to grow abnormally and uncontrollably, forming tumors that can interfere with normal lung function. Non-squamous non-small cell lung cancer refers to a specific subtype that does not include squamous cells, and includes forms such as adenocarcinoma and large cell carcinoma. In advanced or metastatic stages, the cancer has spread beyond the original tumor site to other parts of the lung or to distant organs in the body. The disease can cause symptoms such as persistent cough, chest pain, shortness of breath, and fatigue. As the cancer progresses, it may affect breathing capacity and overall body function due to the spread of cancer cells.