Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
This research study is investigating new drug combinations to treat advanced non-small cell lung cancer (NSCLC), a common type of lung cancer. The main focus is on a new drug called telisotuzumab adizutecan, given by drip, combined with immune checkpoint inhibitors such as budigalimab or pembrolizumab. These treatments aim to help the body's immune system fight cancer. The study is split into two stages: the first stage will find safe and effective doses of the new drug combinations, and the second stage will compare these new combinations against standard treatments. Participants will have regular hospital visits for assessments, blood tests, and to monitor for side effects. The overall goal is to improve treatment options for adult patients with this type of lung cancer who haven't yet received treatment for their advanced disease and don't have certain genetic changes.
At a glance
What is this study about?
This study is looking into new ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has either spread or is advanced. NSCLC is the most common kind of lung cancer. The researchers want to see how well a new drug called telisotuzumab adizutecan works when given along with other drugs that help boost the body's immune system, like budigalimab or pembrolizumab. These immune-boosting drugs, known as PD-1 immune checkpoint inhibitors, aim to help your body's own immune system recognise and fight cancer cells.
The study has two main parts. In the first part, participants will receive telisotuzumab adizutecan along with budigalimab at different doses, starting with lower amounts and gradually increasing. This helps the doctors find a dose that is both well-tolerated and likely to be effective. Once a suitable dose is found, the second part of the study will begin. Here, some participants will receive the new drug combination, while others will receive the standard treatment currently used for this type of lung cancer, which usually involves pembrolizumab, pemetrexed, and a chemotherapy drug like carboplatin or cisplatin.
The main reasons for this study are to check for any side effects from these new drug combinations and to see how much they can reduce or control the cancer's activity. By comparing the new treatments to standard care, researchers hope to find better and safer treatment options for adult patients with advanced NSCLC who haven't had previous treatment for their advanced cancer and don't have certain specific genetic changes in their tumour. This research is important for potentially developing more effective ways to fight lung cancer.
Key takeaways
- New drug combinations are being tested for advanced non-small cell lung cancer.
- The study involves a new drug called telisotuzumab adizutecan combined with immune-boosting therapies.
- It aims to find safe and effective doses and compare them to standard treatments.
- Participants must be adults with advanced NSCLC who haven't had prior treatment and lack certain genetic changes.
- Regular hospital visits, blood tests, and monitoring for side effects are part of taking part.
- The study runs for roughly 33 months.
Who may be eligible?
To join this study, you would need to be an adult with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that hasn't spread to other parts of the brain in an uncontrolled way and can be measured. For the second part of the study, it's important that you haven't received any previous treatment for your advanced lung cancer and your cancer doesn't have certain known genetic changes that can be targeted by other medicines.
Your doctors will also need to check your general health, especially your organ function, to make sure you are well enough to take part. They will also look at specific markers in your cancer cells, including PD-L1 status and c-Met status, to confirm you meet the study's requirements.
You would not be able to join if you have certain lung conditions like a history of serious lung inflammation (interstitial lung disease or pneumonitis) or any signs of it on a recent scan of your chest.
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.
- Are you an adult aged 18 or older?
- Do you have advanced or metastatic non-small cell lung cancer?
- Have you not received any prior treatment for your advanced lung cancer?
- Does your cancer not have certain known genetic changes?
- Do you have generally good organ function?
- Do you not have a history of serious lung inflammation or active lung problems?
What does participation involve?
If you decide to take part in this study, you will have regular visits to a hospital or clinic over approximately 33 months. During these visits, you will receive the study drugs, which will be given as a drip into your vein. The specific drugs and doses will depend on which part of the study you are in.
Throughout the study, the medical team will keep a close eye on your health and how you are responding to the treatment. This will involve various medical checks, blood tests, and questionnaires for you to complete. They will also regularly monitor you for any side effects you might experience. These frequent assessments help the doctors understand the treatment's effects and ensure your safety.
Potential risks and benefits
Locations (97)
- Mayo Clinic Hospital - Phoenix /ID# 272971Verified postcodePhoenix, United States· Active not recruiting
- Providence - St. Jude Medical Center /ID# 271414Verified postcodeFullerton, United States· Recruiting
- FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450Verified postcodeOxnard, United States· Recruiting
- UCLA - Santa Monica /ID# 271690Verified postcodeSanta Monica, United States· Recruiting
- University Of Colorado - Anschutz Medical Campus /ID# 269069Verified postcodeAurora, United States· Recruiting
- Rocky Mountain Cancer Centers - Lone Tree /ID# 272603Verified postcodeLone Tree, United States· Recruiting
- Mayo Clinic Hospital Jacksonville /ID# 275073Verified postcodeJacksonville, United States· Recruiting
- Mid Florida Hematology And Oncology Center /ID# 273777Verified postcodeOrange City, United States· Recruiting
- Hope And Healing Cancer Services /ID# 276223Verified postcodeHinsdale, United States· Recruiting
- Parkview Comprehensive Cancer Center /ID# 271879Verified postcodeFort Wayne, United States· Recruiting
- Community Health Network /ID# 273437Verified postcodeIndianapolis, United States· Completed
- Kansas City Cancer Center /ID# 273679Verified postcodeOverland Park, United States· Recruiting
Common questions
What kind of lung cancer is this study for?
This study is for a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced or has spread, and doesn't have certain genetic changes.
What are 'investigational drugs'?
Investigational drugs are treatments that are still being studied and are not yet approved for general use. They show promise but need more testing.
Will I get the new treatment or standard treatment?
In the second part of the study, you may receive either a new drug combination or the standard treatment, depending on which group you are assigned to.
How long will the study last if I join?
The study is expected to run for about 33 months, and you would have regular visits during this time for treatment and check-ups.
What if I get uncontrolled brain metastases?
If you have or develop uncontrolled cancer that has spread to your brain, you would not be able to participate in this study.
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?
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