A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)
This research is looking at new ways to treat a type of lung cancer called advanced non-small cell lung cancer, specifically for people whose cancer has progressed after standard chemotherapy and a type of immunotherapy. The study is comparing a new combination of two drugs, Sitravatinib and Nivolumab, with a common chemotherapy drug called Docetaxel. Doctors want to see if the new combination can help people live longer (this is the main goal). They will also check if the treatment is safe, how well it shrinks the cancer, and how it affects people's quality of life and symptoms. This is a large study (Phase 3), meaning it's a final step before a new treatment might become widely available.
At a glance
What is this study about?
This clinical trial is for people in the UK living with advanced non-small cell lung cancer that hasn't responded to, or has progressed after, their initial treatments. Specifically, it's for those whose cancer has continued to grow even after having chemotherapy that included platinum-based drugs and also a type of immunotherapy called a 'checkpoint inhibitor'. This means that standard treatments haven't worked as well as hoped, and doctors are looking for new options.
The study is designed to compare a new treatment approach with an existing one. The new approach involves taking two medicines together: Sitravatinib and Nivolumab (also known as Opdivo). Sitravatinib is a drug that aims to block signals that help cancer cells grow, while Nivolumab is an immunotherapy that helps your own immune system fight the cancer. The existing approach used for comparison is a chemotherapy drug called Docetaxel (also known as Taxotere).
The main goal of this research is to see if the new combination of Sitravatinib and Nivolumab helps people with this specific type of advanced lung cancer live longer compared to those treated with Docetaxel. Researchers will also be carefully monitoring how safe the new treatment is, looking at any side effects, and checking how well it shrinks tumours, how long the cancer stays stable, and if it improves patients' daily lives and symptoms. This is a 'Phase 3' study, which means it's a large, important step in determining if a new treatment is effective and safe enough to be used more widely.
Key takeaways
- New combination treatment for advanced lung cancer.
- For those whose previous treatments (chemo + immunotherapy) haven't worked.
- Compares new drugs (Sitravatinib + Nivolumab) to standard chemotherapy (Docetaxel).
- Main goal: see if the new combination helps people live longer.
- Also evaluates safety, tumour shrinkage, and quality of life.
Who may be eligible?
To join this study, you must be at least 18 years old. The study is open to both men and women.
Crucially, you must have advanced non-small cell lung cancer that is 'non-squamous' type. This simply refers to the specific type of cells found in your cancer. Your cancer must also have gotten worse either during or after you've had treatments including both platinum-based chemotherapy and another type of drug called a 'checkpoint inhibitor' (like immunotherapy).
There will be other detailed medical criteria that your doctor will need to check to make sure the study is a safe and suitable option for you. This will involve reviewing your overall health, other medical conditions, and previous treatments.
- Are you 18 years old or older?
- Do you have advanced non-squamous non-small cell lung cancer?
- Has your cancer grown or spread after platinum-based chemotherapy?
- Has your cancer grown or spread after immunotherapy (checkpoint inhibitor)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve regular visits to the clinic for assessments and treatments. You would receive either the combination of Sitravatinib and Nivolumab or the chemotherapy drug Docetaxel, given over a period according to the study plan. Visits will include blood tests, physical examinations, and scans to monitor your health and how the treatment is working. You will also be asked to fill out questionnaires about your symptoms and quality of life. The total duration of your participation in the study will depend on how you respond to the treatment and your progress.
Potential risks and benefits
Locations (3)
- —Spain
- —Netherlands
- —Italy
Common questions
What is 'advanced non-small cell lung cancer'?
This is a common type of lung cancer where the disease has spread to other parts of the body.
What does 'disease progression' mean?
It means your cancer has continued to grow or spread even after previous treatments.
What is the difference between Sitravatinib and Nivolumab?
Sitravatinib works by blocking signals that help cancer grow, while Nivolumab helps your immune system fight the cancer.
Will I know which treatment I am getting?
This is a 'randomised' study, meaning you will be randomly assigned to one treatment group. For some trials, you and your doctor might not know which treatment you are getting; this is called 'blinded'.
What is a 'Phase 3' study?
It's a large study, usually the final step, to confirm if a new treatment is safe and effective compared to existing options before it can be widely approved.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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