Study of Telisotuzumab Vedotin for Adults with Advanced Non-Squamous Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC), specifically the non-squamous subtype that is advanced or has spread to other parts of the body. The study is investigating a treatment called Telisotuzumab Vedotin, which is given as an injection into the vein. This treatment is being tested in patients who have not received any previous treatment for their cancer and have a specific characteristic in their cancer cells called MET amplification.

The purpose of the study is to assess how well Telisotuzumab Vedotin works in treating this type of lung cancer. Participants in the study will receive the medication through an intravenous infusion, which means it is delivered directly into the bloodstream. The study will monitor the participants over a period to see how their cancer responds to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, researchers will evaluate various aspects of the participants’ health, including how long the treatment works, the overall survival of participants, and any changes in symptoms like cough or pain. The study aims to provide valuable information about the effectiveness of Telisotuzumab Vedotin in treating advanced Non-Small Cell Lung Cancer with MET amplification.

1 joining the study

Upon joining the study, you will have already completed an informed consent process. This means you have agreed to participate after understanding the study’s purpose, procedures, and potential risks and benefits.

You must be at least 18 years old and have a specific type of lung cancer called non-squamous non-small cell lung cancer that is either locally advanced or has spread to other parts of the body.

2 eligibility confirmation

Your eligibility will be confirmed through tests to ensure your cancer has a characteristic called MET amplification. This will be determined by analyzing your tumor tissue or blood.

You must have a performance status that indicates you are fully active or restricted in physically strenuous activity but able to carry out light work.

3 treatment initiation

You will begin receiving the study medication, telisotuzumab vedotin, which is administered as an intravenous infusion. This means the medication is given directly into your vein through a needle.

The frequency and duration of the medication administration will be explained to you by the study team.

4 monitoring and assessments

Throughout the study, you will undergo regular assessments to monitor your response to the treatment. This includes imaging tests to measure the size of your tumors and other evaluations to check your overall health.

You will also be asked to complete questionnaires about your quality of life and any symptoms you experience, such as cough, pain, or difficulty breathing.

5 end of treatment

The study will continue until the estimated end date in December 2026, or until you and your doctor decide it is best to stop the treatment.

After completing the treatment, you may have follow-up visits to monitor your health and any long-term effects of the medication.

Who Can Join the Study?

Subjects must have completed an informed consent.
Subject must be an adult, at least 18 years old.
Subject must have MET amplification in tumor tissue. This means that there is an increase in the number of copies of the MET gene in the cancer cells, which is confirmed by specific tests.
Subject must have a type of lung cancer called non-squamous adenocarcinoma NSCLC that is either locally advanced or has spread to other parts of the body (metastatic).
Subject must have measurable disease according to specific criteria (RECIST version 1.1), which means the cancer can be measured on scans.
Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. This is a scale used to assess how a patient’s disease is progressing, with 0 meaning fully active and 1 meaning restricted in physically strenuous activity but able to carry out light work.
Subjects with cancer that has spread to the brain or spinal cord (central nervous system, CNS) can participate if they have received treatment like surgery or radiotherapy, and:
- There is no evidence of the cancer getting worse at least 2 weeks after treatment.
- They have no symptoms and are either not taking or are on a stable or reducing dose of steroids or anticonvulsants for at least 2 weeks before starting the study drug.
Having a history of radiation pneumonitis (inflammation of the lungs due to radiation) in the treated area is allowed.

Who Cannot Join the Study?

Patients who have already received treatment for their lung cancer cannot participate.
Patients with a different type of lung cancer than the one specified in the study cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients with allergies to the study medication or its ingredients cannot participate.
Patients with a history of drug or alcohol abuse cannot participate.
Patients with certain infections, like HIV or hepatitis, cannot participate.
Patients who have had another type of cancer in the past, unless it was treated and cured, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Radiotherapy Center Cluj S.R.L.	Bucharest	Romania
Pius-Hospital Oldenburg	Oldenburg In Holstein	Germany
Spitalul Clinic Coltea	Bucharest	Romania
Universita’ Politecnica Delle Marche	Ancona	Italy
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Hospices Civils De Lyon	Lyon	France
Asklepios Klinik Gauting GmbH	Gauting	Germany
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Spitalul Municipal Ploiesti	Ploiesti	Romania
Ismakm Iuxozyba Fpuqjvpzkiyyg Oaungkkypmg	Rome	Italy
Iqauafhu Cxylkv Dmadqpfpkpxboymmr	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.01.2023
Germany	Not recruiting	01.01.2023
Italy	Not recruiting	01.01.2023
Romania	Not recruiting	01.01.2023
Spain	Not recruiting	01.01.2023

Trial locations

Investigated drugs:

Telisotuzumab Vedotin

Telisotuzumab vedotin is a medication being studied for its potential to treat a specific type of lung cancer known as non-squamous non-small cell lung cancer (NSCLC) that has not been treated before and shows a particular genetic feature called MET amplification. This medication is designed to target and attach to cancer cells with this feature, delivering a substance that can help kill the cancer cells. The goal of using telisotuzumab vedotin in this trial is to see how well it can reduce the size of the tumors in patients with this type of lung cancer.

Non-Squamous Non-Small Cell Lung Cancer – This type of lung cancer is characterized by the presence of cancerous cells in the lung tissue that do not have the flat, thin appearance typical of squamous cells. It is a subtype of non-small cell lung cancer, which is the most common type of lung cancer. The disease progresses as the cancer cells grow and multiply, potentially spreading to other parts of the body. In its advanced stages, it can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. The progression can vary significantly among individuals, with some experiencing rapid advancement while others may have a slower course. The disease is often associated with genetic mutations, such as MET amplification, which can influence its behavior and progression.

Trial ID:

2022-500608-23-00

Protocol code:

M22-137

NCT ID:

NCT05513703

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Telisotuzumab Vedotin for Adults with Advanced Non-Squamous Non-Small Cell Lung Cancer

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