A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
This study is for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or is advanced, and who have already received some treatment. Researchers want to compare a new experimental medicine, Telisotuzumab Vedotin, with a standard chemotherapy drug, Docetaxel. The main aim is to find out if the new drug is more effective at controlling the cancer and how safe it is. Participants will receive one of the two medicines as a drip into their arm. We will be checking how well the treatment works and if there are any side effects. This study will involve nearly 700 people worldwide.
At a glance
What is this study about?
This study is focusing on a type of cancer where cells in the lung grow out of control, specifically called non-small cell lung cancer (NSCLC). If you have this type of lung cancer, and it's advanced or has spread to other parts of your body, and you've already had some treatment for it, this study might be for you. The researchers are particularly interested in people whose cancer cells have a lot of a specific protein on their surface called 'c-Met'.
The main goal is to test a new medicine called Telisotuzumab Vedotin. This new drug is still experimental, meaning it's not yet available as a standard treatment. They want to see if it works better than a common chemotherapy drug called Docetaxel, which is already used to treat lung cancer. They also want to understand if this new drug is safe and what side effects it might have. This comparison will help doctors decide if Telisotuzumab Vedotin could be a new and better way to treat NSCLC.
About 700 adults from different places in the world will take part. Participants will be randomly assigned to receive either the new drug or Docetaxel, like flipping a coin to decide. Both treatments are given through a drip into a vein. Doctors will carefully monitor how the cancer responds to the treatment and keep a close eye on any health changes or side effects that participants experience.
Key takeaways
- Tests a new medicine (Telisotuzumab Vedotin) for advanced non-small cell lung cancer.
- Compares the new medicine to a standard chemotherapy (Docetaxel).
- Focuses on patients whose cancer has a lot of 'c-Met' protein.
- Involves regular hospital visits for treatments and health checks.
- Aims to find out if the new medicine is safer and more effective.
Who may be eligible?
To join this study, your doctor will need to confirm you have non-small cell lung cancer (NSCLC) that is locally advanced or has spread. A special test on your tumor tissue must show that your cancer cells have a high level of a protein called 'c-Met'. You also need to have tried at least one other treatment for your advanced lung cancer already, and it should no longer be working as well as it did.
There are also some important markers your doctor will check. For example, if you have certain changes in your genes like specific EGFR mutations, this study might not be suitable for you. Your overall health and how well you can move around (your 'performance status') are also considered, aiming for good general health when you start. You will also need to be expected to live for at least another 12 weeks.
Ultimately, your study doctor will decide if you fit all the criteria. They will look at your past treatments, current health, and specific features of your cancer to make sure this study is right and safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do you have advanced or spread non-small cell lung cancer?
- Has your lung cancer been checked for 'c-Met' protein and found to be high?
- Have you already received at least one prior treatment for your advanced lung cancer?
- Is your general health good enough to participate in a clinical study?
- Do you not have an 'EGFR activating mutation' as determined by your doctor?
What does participation involve?
If you decide to join this study, you will have regular visits to a hospital or clinic. These visits will involve various medical checks, including blood tests and assessments to see how your cancer is responding to the treatment. You will also be asked about your side effects and to complete questionnaires about how you are feeling.
You will receive a treatment, either Telisotuzumab Vedotin or Docetaxel, through a drip into your arm. Telisotuzumab Vedotin is given every two weeks, while Docetaxel is given every three weeks. You will continue to receive this treatment for as long as it's helping you and you are not experiencing severe side effects. The study will continue until the doctors decide it's no longer beneficial for you.
There might be more hospital visits and tests than you would usually have with your standard care. If the treatment is working well for you when the main study finishes, there might be options for you to continue receiving the study medicine. Your participation will involve regular checks for several months, potentially longer, depending on how you respond to the treatment.
Potential risks and benefits
Locations (317)
- University of Alabama at Birmingham - Main /ID# 247074Verified postcodeBirmingham, United States· Active not recruiting
- Ironwood Cancer & Res Ctr /ID# 262446Verified postcodeChandler, United States· Active not recruiting
- Mayo Clinic Arizona /ID# 255858Verified postcodePhoenix, United States· Active not recruiting
- Onvida Health Yuma Medical Center /ID# 253625Verified postcodeYuma, United States· Completed
- City of Hope /ID# 243157Verified postcodeDuarte, United States· Recruiting
- City Of Hope - Seacliff /ID# 263143Verified postcodeHuntington Beach, United States· Recruiting
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144Verified postcodeIrvine, United States· Recruiting
- City Of Hope - Antelope Valley /ID# 263138Verified postcodeLancaster, United States· Recruiting
- The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774Verified postcodeLos Angeles, United States· Completed
- University of California, Los Angeles /ID# 253954Verified postcodeLos Angeles, United States· Recruiting
- Eisenhower Medical Center /ID# 233189Verified postcodeRancho Mirage, United States· Recruiting
- Mayo Clinic Hospital Jacksonville /ID# 254688Verified postcodeJacksonville, United States· Active not recruiting
Common questions
What is Non-Small Cell Lung Cancer (NSCLC)?
It's a common type of lung cancer where cancer cells form in the lung tissues. This study is for advanced or spread NSCLC.
What are Telisotuzumab Vedotin and Docetaxel?
Telisotuzumab Vedotin is a new, experimental drug being tested. Docetaxel is an established chemotherapy drug already used for lung cancer.
Why do they need my tumor tissue?
Researchers need to test your tumor tissue for a specific protein called 'c-Met' to see if your cancer is suitable for this study.
How will I receive the treatment?
Both medicines are given as a drip (intravenous infusion) into a vein in your arm, either every two or three weeks.
Can I stop participating in the study?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
ABBVIE CALL CENTER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.