A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination with Platinum-Pemetrexed Chemotherapy in Patients with Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
This clinical trial is looking at a new treatment combination for adults with newly diagnosed, advanced non-small cell lung cancer that has spread to other parts of the body. The study compares an experimental medicine called CT-P51 with Keytruda (pembrolizumab), which is already a standard immunotherapy used in the UK. Both drugs are given alongside standard platinum and pemetrexed chemotherapy. CT-P51 is designed to be a biosimilar, meaning it is made to work in the exact same way as Keytruda. Participants will be placed into one of two groups by chance. Neither you nor your study doctor will choose which treatment you receive. Researchers will monitor your health and scan your lungs regularly to check how well the treatment shrinks the cancer and to record any side effects you might experience.
At a glance
What is this study about?
Non-small cell lung cancer is the most common type of lung cancer. When cancer is 'metastatic', it means cancer cells have spread from the lungs to other areas of the body. For people newly diagnosed with this type of cancer, doctors often recommend a combination of immunotherapy and chemotherapy. Immunotherapy helps the body's own immune system find and attack cancer cells, while chemotherapy attacks fast-growing cells directly.
Keytruda (pembrolizumab) is an approved immunotherapy that is widely used to treat this condition. In this trial, researchers are testing a new medicine called CT-P51. CT-P51 is developed as a 'biosimilar' to Keytruda. A biosimilar is a biological medicine that is designed to be highly similar to an original, approved medicine. If tests show that biosimilars work just as well and are just as safe, they can provide more treatment options and help health services like the NHS manage costs.
This Phase 3 study aims to confirm whether CT-P51 shrinks tumours as effectively as Keytruda when both are combined with standard chemotherapy drugs (pemetrexed and either cisplatin or carboplatin). Researchers will also closely compare the safety and side effects of both treatments over several months to ensure patient wellbeing.
Key takeaways
- Tests a proposed biosimilar medicine (CT-P51) against Keytruda (pembrolizumab).
- Open to adults with newly diagnosed, advanced non-squamous non-small cell lung cancer.
- All participants receive active treatment combined with standard chemotherapy.
- The main goal is to confirm that CT-P51 shrinks tumours as effectively and safely as Keytruda.
- Participation is entirely voluntary and you can stop at any point.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with advanced (metastatic) non-squamous non-small cell lung cancer. It is specifically designed for people who have not yet had any chemotherapy or immunotherapy treatment for their advanced cancer.
To be suitable, participants generally need to be well enough to carry out daily tasks independently or with minimal help. Doctors will check that your heart, liver, and kidneys are working well enough to safely handle the medicines.
You may not be eligible if your lung cancer has specific genetic changes that have other targeted treatments, or if you have certain active autoimmune conditions. Your hospital care team can look at your medical history to see if the study fits your situation.
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 advanced or metastatic non-small cell lung cancer.
- My cancer is 'non-squamous' type.
- I have not yet received chemotherapy or immunotherapy for my advanced cancer.
- I am well enough to attend regular hospital appointments for treatment and scans.
What does participation involve?
Taking part involves regular visits to a hospital clinic or clinical trial centre. You will receive your treatments as an infusion (a slow drip into a vein) in repeating cycles, typically every three weeks. At these visits, you will receive either CT-P51 or Keytruda, alongside standard chemotherapy medicines.
Before and during treatment, you will have regular health checks, including physical exams, blood tests, and scans (such as CT or MRI scans) to check how your tumour is responding. You will also be asked about how you are feeling and any side effects. Total participation can last for several months or longer, depending on how well the treatment works and how you tolerate it. After treatment finishes, the study team will continue to check on your health periodically.
Potential risks and benefits
Locations (6)
- —UnverifiedRomania
- —UnverifiedCroatia
- —UnverifiedSpain
- —UnverifiedGreece
- —UnverifiedPoland
- —UnverifiedLithuania
Common questions
What is a biosimilar medicine?
A biosimilar is a biological treatment that is designed to be nearly identical to an existing, approved brand-name medicine. It is thoroughly tested to make sure it works in the same way and is just as safe.
Could I receive a placebo (dummy treatment)?
No. In this trial, every participant receives active cancer treatment. You will receive either the study medicine (CT-P51) or Keytruda, and both groups receive standard chemotherapy.
How is the treatment given?
The medicines are given as an intravenous infusion (a drip into a vein in your arm or through a chest line) during visits to the hospital clinic.
Will taking part cost me anything?
No, the study medicines and all trial-related tests are provided free of charge. Some trials may also help cover travel expenses to and from hospital visits.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the trial at any time, for any reason. Your doctor will discuss alternative treatment options with you, and your standard NHS care will continue.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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