Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC
The RAISE study is testing a new approach for people with advanced small cell lung cancer (SCLC) that has a specific marker (SLFN11-positive). After their initial chemotherapy and immunotherapy, patients will receive a drug called niraparib, along with their ongoing immunotherapy. The study wants to find out if adding niraparib can help keep the cancer from growing or spreading. This is a Phase 2 study, meaning it's exploring the effectiveness of this new combination. It's for adults whose cancer hasn't progressed after their first round of treatment and who are healthy enough for continued immunotherapy.
At a glance
What is this study about?
This research study, called RAISE, is looking at a new way to treat extensive-stage small cell lung cancer (SCLC). This is a type of lung cancer that has spread quite widely. We are particularly interested in patients whose cancer cells show a specific feature, almost like a tag, called SLFN11-positive. This study is for people who have already had their first round of standard treatment, which usually involves chemotherapy combined with immunotherapy, and whose cancer has been stable and hasn't grown since.
The main idea behind this study is to see if adding an extra medication, called niraparib, to the ongoing immunotherapy treatment can improve how well the cancer is controlled. Immunotherapy helps your body's own immune system fight cancer. Niraparib is a type of drug that works differently, by targeting cancer cells in another way. By combining these two treatments, researchers hope to get a stronger effect against the cancer.
The goal of this study is to understand if this new combination treatment can either slow down the cancer's growth or stop it from coming back for longer. It's a 'Phase 2' trial, which means it's one of the earlier stages of drug testing in humans, focusing on whether the treatment works and is safe enough to explore further. This research is important because doctors are always looking for better ways to treat small cell lung cancer.
Key takeaways
- This study is for people with advanced SCLC that has a specific marker called SLFN11-positive.
- It tests adding a new drug, niraparib, to ongoing immunotherapy after initial treatment.
- The main aim is to see if this combination helps control the cancer better.
- Participation involves regular hospital visits for medication, tests, and monitoring.
- You must have completed standard chemo-immunotherapy and your cancer must not have worsened.
- Your general health and organ function must be good enough for the study treatments.
Who may be eligible?
This study is for adults aged 18 or older who have extensive-stage small cell lung cancer. A key requirement is that your cancer cells must have a specific marker called 'SLFN11-positive', which will be checked from a recent biopsy. Also, you must have already completed your first course of chemotherapy combined with immunotherapy (specifically atezolizumab or durvalumab), and your cancer must not have grown or spread during or after this initial treatment.
You also need to be well enough to continue with immunotherapy. This means your general health, including your blood, kidney, and liver function, must be good. Your doctor will assess your overall fitness for the study, often using a common scale where a score of 0, 1, or 2 indicates you are active and able to perform most daily tasks.
Several factors would mean you can't join the study. For instance, if your cancer has spread to your brain and is causing symptoms, or if you have certain other active cancers (unless they are very low risk and have been treated successfully). The research team will carefully review all your medical information to confirm if this study is suitable 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.
- Are you 18 years old or older?
- Do you have extensive-stage small cell lung cancer that has tested positive for SLFN11 marker?
- Have you already had your first course of chemotherapy and immunotherapy, and your cancer hasn't progressed?
- Are you generally well and able to continue with immunotherapy?
- Do you currently have good blood, kidney, and liver function?
- Do you have any active symptomatic brain metastases or other serious cancers?
What does participation involve?
If you decide to take part, your journey will begin with a review of your existing tissue samples to check for the specific SLFN11 marker. If you qualify, you'll then start taking niraparib, a tablet taken once a day, in addition to continuing your regular immunotherapy infusions. You'll have regular appointments at the hospital to monitor your health, check for side effects, and assess how the treatment is working. These visits will involve blood tests, scans, and discussions with the study team.
The exact number and duration of visits will be explained by the study team, but throughout the treatment phase, you can expect frequent check-ups. The treatment will continue as long as it is helping you and you are not experiencing severe side effects. After stopping the study treatment, there will likely be follow-up appointments to track your health over time. The total duration of your participation in the study itself is not specified but will be clearly outlined by the study team before you agree to join.
Potential risks and benefits
Locations (18)
- CHU - AngersVerified postcodeAngers, France· Recruiting
- Centre Hospitalier d'AvignonVerified postcodeAvignon, France· Recruiting
- Caen - CHUVerified postcodeCaen, France· Recruiting
- Lyon - Centre Léon BérardVerified postcodeLyon, France· Not yet recruiting
- LMU Klinikum / Thoracic Oncology center MünichVerified postcodeMünchen, Germany· Recruiting
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)Verified postcodeMeldola, Italy· Recruiting
- Instituto Europeo di Oncologia (IEO)Verified postcodeMilan, Italy· Not yet recruiting
- Santa Maria della Misericordia HospitalVerified postcodePerugia, Italy· Recruiting
- Complejo Hospitalario Universitario a CoruñaVerified postcodeA Coruña, Spain· Not yet recruiting
- Complejo Hospitalario de JaénVerified postcodeJaén, Spain· Recruiting
- Hospital Universitario Puerta de HierroVerified postcodeMadrid, Spain· Recruiting
- Kantonsspital BadenVerified postcodeBaden, Switzerland· Recruiting
Common questions
What is extensive-stage small cell lung cancer?
This means the small cell lung cancer has spread beyond the lung where it started to other parts of the body.
What does being 'SLFN11-positive' mean?
It means your cancer cells have a specific protein called SLFN11, which doctors will test for to see if this study is suitable for you.
What is niraparib?
Niraparib is an oral medication (a pill) being tested in this study to see if it can help fight cancer when added to immunotherapy.
What is immunotherapy?
Immunotherapy is a treatment that helps your body's immune system recognise and fight cancer cells more effectively.
Can I stop participating in the study at any time?
Yes, you can choose to leave the study at any point, and it will not affect your future medical care.
How to find out more
Heidi Roschitzki, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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