A Phase II, single-arm trial on the addition of the DLL3xCD3 bispecific T-cell engager obrixtamig (BI 764532) to standard-of-care platinum-based first-line treatment of advanced large-cell neuroendocrine carcinoma of the lung (ALPINE 2)
This study looks at a new treatment for adults with an advanced, rare lung cancer called large-cell neuroendocrine carcinoma (LCNEC). 'Advanced' means the cancer has spread and cannot be cured with surgery. The usual first treatment is standard chemotherapy. In this study, doctors want to find out if adding an experimental drug called obrixtamig to standard chemotherapy works better than chemotherapy alone. Obrixtamig is a type of immunotherapy. It acts like a bridge, connecting your own immune cells directly to the cancer cells to help your body attack them. Because this is a Phase II study with a single group, all participants receive obrixtamig alongside standard chemotherapy. Doctors will monitor how well the treatment controls the cancer, check for side effects, and see whether it helps patients live longer.
At a glance
What is this study about?
Large-cell neuroendocrine carcinoma of the lung (LCNEC) is an uncommon, fast-growing type of lung cancer. When it is diagnosed at an advanced stage, it means the cancer cells have spread within the chest or to other parts of the body. At this point, operations cannot remove all the cancer, so standard treatment usually involves chemotherapy medicines to help slow down tumour growth and ease symptoms.
Researchers are investigating whether adding a new drug called obrixtamig (also known as BI 764532) can improve how well treatment works. Obrixtamig is a targeted immunotherapy. It is designed to recognise a specific protein on these lung cancer cells while simultaneously grabbing hold of your body's infection-fighting immune cells (T-cells). By pulling the two together, it helps your immune system identify and destroy the cancer cells.
The main aim of this trial, called ALPINE 2, is to measure overall survival—meaning how long patients live after starting the treatment. Because this is a 'single-arm' trial, there is no dummy drug (placebo). Every person who joins will receive the combination of obrixtamig and standard chemotherapy.
Key takeaways
- Tests adding a new immunotherapy drug (obrixtamig) to standard chemotherapy.
- Aimed at adults with advanced or metastatic large-cell neuroendocrine lung cancer.
- All participants receive the study medicine; there is no placebo.
- The primary goal is to see if this combination helps patients live longer.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to men and women aged 18 and over who have been diagnosed with advanced or metastatic large-cell neuroendocrine lung cancer. It is aimed at people whose cancer cannot be cured with surgery or radiotherapy alone.
To be suitable, participants should generally be looking for their first course of drug treatment for this advanced stage of cancer. You will also need to be reasonably active and well enough to carry out daily tasks, with suitable blood test results showing that your liver, kidneys, and bone marrow can cope with chemotherapy.
You may not be eligible if you have already had extensive treatment for advanced cancer, or if you have other serious medical issues, such as active autoimmune conditions or severe infections. The trial doctors will carry out health checks to make sure the trial is 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.
- I am aged 18 or older.
- I have been diagnosed with large-cell neuroendocrine carcinoma of the lung (LCNEC).
- My cancer is advanced or has spread, meaning it cannot be cured by surgery.
- I have not yet started first-line chemotherapy for advanced cancer.
- I am generally well enough to manage my day-to-day activities.
What does participation involve?
Taking part involves regular visits to a specialist hospital clinic. Before starting, you will have checks such as blood tests, heart checks (ECGs), and CT or PET scans to see how you are doing. If you join, both obrixtamig and the chemotherapy drugs will be given as a drip directly into a vein (an intravenous infusion). You will visit the clinic regularly for treatment and follow-up reviews so doctors can see how you feel and monitor for any side effects. You will also have periodic scans to check if the cancer has shrunk or stayed the same. Treatment generally continues for as long as it keeps your cancer under control and any side effects are manageable. After treatment ends, the medical team will keep in touch to check on your long-term health.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
Will I be given a dummy drug (placebo)?
No. This is a single-arm trial, which means every patient accepted onto the study will receive obrixtamig alongside standard chemotherapy.
How is obrixtamig given?
It is given as an intravenous infusion, meaning it is delivered through a small tube directly into a vein at the clinic.
Do I have to pay to take part?
No, you do not pay for trial medications or tests. In many cases, help may also be available to cover your travel expenses to and from the hospital.
What happens if I experience bad side effects?
Your doctors will check you regularly. If you develop troublesome side effects, they can pause treatment, adjust doses, or provide supportive medicines to help you feel better.
Can I leave the study if I change my mind?
Yes, you can leave the study at any point without needing to give a reason. Your usual medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.