Active not recruitingPHASE2INTERVENTIONAL

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

This research study is looking at a new treatment called telisotuzumab vedotin for people with advanced non-small cell lung cancer (NSCLC) that has specific features, particularly the presence of a protein called c-Met. The study is divided into stages. First, it identifies which patients with c-Met positive lung cancer respond best to this new drug, especially after they've had other treatments. Then, it expands to further check how effective the treatment is in these patient groups. Finally, an additional group will also look at safety and effectiveness at a different dose. The main goal is to understand how well telisotuzumab vedotin works and for whom, in patients who have already received other treatments.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AbbVie

Enrolment target

270

Start

10 Oct 2018

Estimated completion

01 Aug 2026

Non-small Cell Lung Cancer

What is this study about?

This study is investigating a new treatment called telisotuzumab vedotin for people who have advanced non-small cell lung cancer (NSCLC). This type of lung cancer is often identified by a specific protein called c-Met, which is found on the cancer cells. Researchers believe that telisotuzumab vedotin might be particularly effective for cancers that have this c-Met protein.

The study is happening in different steps. Initially, the goal is to pinpoint exactly which patients with this c-Met positive lung cancer benefit most from the new drug, especially if their cancer has come back or worsened after previous treatments. Once these patient groups are identified, the study will expand to gather more information on how well the treatment works for them. There will also be a part of the study focused on understanding the safety and effectiveness of the treatment at a different dose.

Ultimately, this research helps doctors understand better how telisotuzumab vedotin could be used to treat non-small cell lung cancer. The aim is to find effective new options for patients, especially those who have already tried other available treatments.

Key takeaways

This study is for advanced non-small cell lung cancer.
It's testing a new medicine called telisotuzumab vedotin.
Participants must have cancer with a specific protein called c-Met.
It's for people who have already tried other treatments.
The study aims to find out how well the new medicine works and for whom.
Close monitoring for safety and effectiveness is part of the study.

Who may be eligible?

To join this study, you need to have a specific type of advanced non-small cell lung cancer that has spread or is locally advanced. Your cancer cells must also show a certain protein called c-Met, which will be checked from a sample of your tumour. This sample can be from a previous biopsy or a new one if needed. Importantly, if your lung cancer is non-squamous, your doctors must also confirm that it doesn't have a specific change (mutation) in a gene called EGFR, which is sometimes seen in lung cancer.

You should have already received some treatments for your advanced lung cancer, but no more than two different types of overall treatment. This includes having tried chemotherapy (unless you can't have it) and a type of medicine called an immune checkpoint inhibitor. If your cancer has certain other gene changes, you should have already tried treatments for those too.

There are also some general health requirements. You should be feeling well enough to carry out most daily activities, meaning you have an ECOG Performance Status of 0 or 1. If your cancer has spread to your brain, this is okay, but you must have already had treatment for it, like surgery or radiation, according to the study's rules.

Quick self-check

Do I have advanced non-small cell lung cancer?
Has my doctor confirmed my cancer has the c-Met protein?
Have I already received one or two lines of cancer treatment?
Am I generally well enough to do most daily activities (ECOG 0-1)?
If I have non-squamous lung cancer, does my doctor know my EGFR status and is it 'wild type'?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would receive the study medicine, telisotuzumab vedotin. The study team will explain how often you would receive this medicine. You would have regular appointments at the clinic to check on your health and how you are responding to the treatment. These appointments will involve various tests, such as blood tests, scans, and physical examinations. The exact number of visits and tests will be detailed by the study team.

Throughout the study, doctors will closely monitor your condition and any side effects you might experience. The total duration of your participation in the study will depend on how your cancer responds to the treatment and your general health, but you will continue to be monitored even after you stop receiving the study drug. All visits, assessments, and the study medication will be provided as part of your participation.

Potential risks and benefits

Participating in a clinical trial like this may offer potential benefits, such as receiving a new treatment that is not yet widely available for your condition. However, there are also potential risks, as with any new medicine. Telisotuzumab vedotin may have side effects, and some could be serious. The research team will carefully monitor you for any side effects and will explain them to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (252)

University of South Alabama /ID# 212939
Mobile, United States
Mayo Clinic Arizona /ID# 218550
Phoenix, United States
Highlands Oncology Group, PA /ID# 215600
Springdale, United States
University of California, Los Angeles /ID# 203219
Los Angeles, United States
LA Hematology-Oncology Med Group /ID# 203338
Orange, United States
Sutter Medical Center Sacramen /ID# 203299
Sacramento, United States
Icri /Id# 227835
Whittier, United States
Univ of Colorado Cancer Center /ID# 203212
Aurora, United States
Duplicate_Rocky Mountain Cancer Centers - Lone Tree /ID# 215789
Lone Tree, United States
Advanced Cancer Treatment Center /ID# 239565
Brooksville, United States
AdventHealth Celebration /ID# 215649
Celebration, United States
Duplicate_Mayo Clinic /ID# 218488
Jacksonville, United States

+240 more sites — see the official record for the full list.

Common questions

What is c-Met positive lung cancer?

This is a type of non-small cell lung cancer where the cancer cells have a specific protein called c-Met on their surface. The study is particularly looking at treatments that might target this protein.

What is telisotuzumab vedotin?

It's the new experimental medicine being tested in this study. It's designed to go after cancer cells that have the c-Met protein.

Why is this study only for people who have had other treatments?

This study is looking for new options for patients whose cancer has progressed or returned after standard treatments. It aims to see if telisotuzumab vedotin can help in these situations.

What does 'non-squamous EGFR wild type' mean?

This describes a specific characteristic of your lung cancer. 'Non-squamous' refers to the type of lung cancer cells, and 'EGFR wild type' means your cancer doesn't have a common specific genetic change (mutation) in the EGFR gene that doctors often treat differently.

Can I leave the study if I change my mind?

Yes, absolutely. Your participation is completely voluntary, and you can choose to leave the study at any time without having to give a reason, and it won't affect your future medical care.