A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
This study is for adults with advanced small cell lung cancer or other types of neuroendocrine cancers. It's looking into new treatments called obrixtamig and ZL-1310. The study has two main parts. Part 1 focuses on finding the right and safest dose of these two medicines when given together. Part 2 then checks how well obrixtamig and ZL-1310 work when combined with another medicine, a 'checkpoint inhibitor', which helps your body's immune system fight cancer. Researchers also want to see if these treatments can stop cancer from growing or keep it stable. All study medicines are given directly into a vein. This research hopes to find new ways to help people living with these cancers.
At a glance
What is this study about?
This study is investigating new treatments, obrixtamig and ZL-1310, for adults who have advanced small cell lung cancer or other types of neuroendocrine cancers. Neuroendocrine cancers are a group of unusual cancers that start in special cells called neuroendocrine cells, which are found all over the body. 'Advanced' means the cancer has grown or spread.
The study is divided into two main parts. The first part aims to carefully find the best and safest dose of the combination of obrixtamig and ZL-1310. Once a safe dose is identified, the second part of the study will then look at how these two medicines work when given alongside another type of drug called a 'checkpoint inhibitor'. Checkpoint inhibitors are designed to help your body's own immune system recognise and fight cancer cells more effectively. For this study, the checkpoint inhibitor being used is atezolizumab.
The main goals of this research are to see if these new treatments can stop cancer from growing, keep it stable, or even shrink it. Obrixtamig and ZL-1310 are being developed with the idea that they can help boost your immune system's ability to combat the cancer. By understanding how these medicines work and what dose is most effective and safe, doctors hope to find better treatment options for these types of cancers.
Key takeaways
- The study tests new treatments, obrixtamig and ZL-1310, for advanced lung and neuroendocrine cancers.
- It aims to find safe doses and see if treatments can stabilise or shrink tumours.
- Part 2 of the study combines these new drugs with an immune-boosting medicine (atezolizumab).
- Treatments are given by infusion, and participants have regular medical check-ups.
- You can take part for up to two years if the treatment is beneficial and you tolerate it well.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is for adults aged 18 or older. To be considered for Part 1 of the study, you must have advanced small cell lung cancer, a specific type of advanced large cell neuroendocrine lung cancer, or certain advanced neuroendocrine cancers that have spread to other parts of the body. Your doctor will confirm if your cancer type fits these descriptions, especially if your tumour is made up of different cell types.
You should have already tried other available treatments that haven't worked or are not suitable for you, and these treatments must usually include a chemotherapy called platinum-based chemotherapy, unless there's a good medical reason you couldn't have it.
For Part 2 of the study, it's specifically for people with advanced small cell lung cancer (known as 'extended stage'). You must not have had any previous treatment for this type of advanced small cell lung cancer. However, if you had chemoradiotherapy for a less advanced stage of the disease, you might still be eligible if it was at least six months ago.
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 (18 years or older)?
- Do you have advanced small cell lung cancer or another type of advanced neuroendocrine cancer?
- Have you already tried other cancer treatments or are unable to have them?
- For advanced small cell lung cancer only (Part 2): Have you recently received no prior treatment for the currently active advanced stage of your cancer?
What does participation involve?
If you join the study, you will receive the study medicines as infusions directly into a vein. In Part 1, you will get obrixtamig and ZL-1310. In Part 2, you will receive obrixtamig, ZL-1310, and an additional medicine called a checkpoint inhibitor (atezolizumab). All participants in Part 2 must have advanced small cell lung cancer.
There isn't a set time limit for how long you'll be in the study. You can continue to receive treatment for up to two years, as long as the treatment is helping you and you are tolerating it well. You will need to visit the study clinic regularly, and some of these visits might involve staying overnight. During these visits, the study team will closely monitor your health for any side effects from the treatment, check the size of your tumours, and take blood samples for lab tests.
Potential risks and benefits
Locations (24)
- MedStar Georgetown University HospitalVerified postcodeWashington D.C., United States
- University of Kentucky Medical CenterVerified postcodeLexington, United States
- Chris Obrien LifehouseVerified postcodeCamperdown, Australia
- Edegem - UNIV UZ AntwerpenVerified postcodeEdegem, Belgium
- Universitair Ziekenhuis GentVerified postcodeGhent, Belgium
- The Affiliated Cancer Hospital, Guangxi Medical UniversityVerified postcodeNanning, China
- Shanghai Chest HospitalVerified postcodeShanghai, China
- Shanghai Pulmonary HospitalVerified postcodeShanghai, China
- CTR Leon BerardVerified postcodeLyon, France
- HOP TimoneVerified postcodeMarseille, France
- Institut Gustave RoussyVerified postcodeVillejuif, France
- Charité - Universitätsmedizin BerlinVerified postcodeBerlin, Germany
Common questions
What types of cancer is this study for?
This study is for advanced small cell lung cancer and certain other types of neuroendocrine cancers.
What are 'obrixtamig' and 'ZL-1310'?
These are new medicines being developed to help your immune system fight cancer.
How will I receive the study medicines?
All study medicines will be given to you through an infusion, which means they go directly into a vein.
How long will I be in the study?
There's no fixed time. You could receive treatment for up to two years if it's helping you and you can tolerate it.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your other medical care.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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