A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)
This research study is testing a new treatment, anvumetostat, for advanced non-small cell lung cancer (NSCLC) in people whose cancer cells are missing a specific gene called MTAP. This missing gene, also known as an MTAP deletion, is a key focus of the study. We aim to understand two main things: firstly, how safe the drug is at different doses and what side effects it might cause, and secondly, how well it works to treat the cancer when reviewed by independent experts. Participants in the study will have already tried at least one other treatment for their advanced cancer. The study is open to adults aged 18 to 99, of any sex.
At a glance
What is this study about?
This study, called MTAPESTRY 201, is looking at a new drug called anvumetostat for a specific type of advanced lung cancer. This cancer is known as non-small cell lung cancer (NSCLC), and it's particularly important that the cancer cells in this study are missing a gene called MTAP. This 'MTAP deletion' is the key feature that makes someone eligible for this study, as the drug anvumetostat is designed to target cancers with this missing gene.
The main reasons for doing this study are to carefully check how safe anvumetostat is at two different dose levels and to see how well it works against the cancer. We'll be looking at whether it can help to slow down the cancer's growth or even shrink it. To make sure the results are fair, independent experts will also review how effective the drug is without knowing which dose a patient received.
Finding new and effective treatments for advanced lung cancer is really important. By focusing on cancers with this specific MTAP deletion, researchers hope to develop a more targeted treatment that could potentially help people who haven't responded well to other therapies. This study is a crucial step in understanding if anvumetostat could be a new option for patients with this particular type of lung cancer.
Key takeaways
- This study is for advanced lung cancer (NSCLC) with a specific genetic change (MTAP deletion).
- It's testing a new drug called anvumetostat to see how safe and effective it is.
- Participants must have already tried at least one other treatment for their advanced cancer.
- The study includes adults aged 18 to 99.
- Your cancer cells must be missing the MTAP gene to be eligible.
Who may be eligible?
To join this study, you would need to be an adult between 18 and 99 years old. Your non-small cell lung cancer must have spread or be advanced, and critically, your cancer cells must be confirmed to be missing the MTAP gene. You also need to have tried at least one other treatment for your advanced cancer already, and it either didn't work well enough or your cancer came back.
Researchers will also need to review a sample of your cancer tissue. If you have been treated for brain tumours, you might still be able to join, as long as it was at least 14 days ago. Even if you have small, untreated brain tumours that aren't causing symptoms and don't need steroid treatment, you might still be considered.
However, you wouldn't be able to join if your cancer has certain other gene changes that can be treated with different targeted drugs (like EGFR, ALK, or BRAF). You also couldn't join if you've had major surgery recently (within the last 28 days), or if you have untreated brain tumours that are causing symptoms or are larger than 2cm.
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 18 to 99 years old?
- Do you have advanced non-small cell lung cancer?
- Has your doctor confirmed your cancer is missing the MTAP gene?
- Have you already had at least one treatment for your advanced cancer that didn't work well or your cancer came back?
- Do you not have certain other specific gene changes in your cancer (like EGFR or ALK) that are treatable with other targeted drugs?
- Have you not had a major surgery in the last 28 days?
What does participation involve?
The detailed information about what taking part involves is not provided in this summary. However, generally, participation in a clinical study like this would typically involve regular visits to the study clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would be given the study drug, anvumetostat, as directed by the study team. The total duration of your participation would depend on how well you respond to the treatment and your overall health, but typically studies involve a treatment phase followed by a follow-up period to track your progress.
Potential risks and benefits
Locations (91)
- City of Hope National Medical CenterVerified postcodeDuarte, United States
- City of Hope Orange County Lennar Foundation Cancer CenterVerified postcodeDuarte, United States
- Cedars-Sinai Medical CenterVerified postcodeLos Angeles, United States
- Valkyrie Clinical TrialsVerified postcodeLos Angeles, United States
- University of California Los AngelesVerified postcodeLos Angeles, United States
- Rocky Mountain Cancer CentersVerified postcodeDenver, United States
- Eastern Connecticut Hematology and Oncology AssociatesVerified postcodeNorwich, United States
- Hartford HealthCare Cancer Institute - ManchesterVerified postcodePlainville, United States
- Medstar Georgetown University HospitalVerified postcodeWashington D.C., United States
- Our Lady of the Lake Cancer InstituteVerified postcodeBaton Rouge, United States
- Trinity Health Saint Joseph Mercy Ann ArborVerified postcodeAnn Arbor, United States
- Cancer and Hematology Centers of Western MichiganVerified postcodeGrand Rapids, United States
Common questions
What is MTAP-deleted NSCLC?
It's a specific type of advanced lung cancer where the cancer cells are missing a gene called MTAP. This study is focused on treatments for this particular type.
What is anvumetostat?
Anvumetostat is a new drug being tested in this study. Researchers want to see if it's safe and effective for people with MTAP-deleted lung cancer.
How long will the study last?
The information provided doesn't specify the exact duration. Clinical trials usually involve a treatment phase and then a follow-up period, which varies for each person.
Will I receive the new drug?
Yes, if you meet all the eligibility criteria and join the study, you would receive the study drug, anvumetostat.
Can I leave the study at any time?
Yes, you have the right to leave the study at any point, for any reason, and this won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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