Investigation-specific Appendix 2to Master Protocol PLATFORMPANSC2001 (KALEIDOSCOPE) A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer - PolyDamas
This study is looking at a new treatment approach for people with metastatic non-small cell lung cancer, which is lung cancer that has spread to other parts of the body. Researchers are testing two medicines called amivantamab and cetrelimab given together. The trial has two main goals. First, doctors want to make sure the combination is safe and check what kind of side effects it may cause. Second, they want to see how well the drugs work at shrinking tumours or stopping the cancer from growing. Taking part involves receiving the study drugs through a drip (infusion) and attending regular hospital visits for health checks and scans. The trial is open to adults aged 18 and over. It offers researchers valuable information to help find better, more effective treatment options for people living with advanced lung cancer.
At a glance
What is this study about?
Non-small cell lung cancer is the most common type of lung cancer. When it is described as 'metastatic', it means the cancer cells have spread from the lungs to other areas of the body. At this stage, standard treatments may not always keep the disease under control, so researchers are continually searching for newer, more effective options.
This study, called PolyDamas (part of the wider KALEIDOSCOPE project), tests a combination of two newer medicines: amivantamab and cetrelimab. Both are designed to help your body fight cancer in different ways. One targets specific proteins on cancer cells to stop them growing, while the other helps your immune system recognise and attack the tumour.
Because this is an early-stage study (Phase 1/2), doctors first need to confirm the safest doses to use and keep a close eye on any side effects. They also want to see whether using both drugs together works better than current options at shrinking tumours. Studies like this are vital for discovering whether new drug combinations can help people live longer, healthier lives.
Key takeaways
- Tests a new combination of two targeted cancer drugs: amivantamab and cetrelimab.
- Open to adults aged 18 and over with metastatic non-small cell lung cancer.
- Aims to check the safety of the combination and see if it can shrink tumours.
- Treatment is given through a drip at a hospital clinic alongside regular scans.
- Joining is entirely optional, and you can stop taking part at any time.
Who may be eligible?
This trial is open to adults aged 18 or older who have been diagnosed with metastatic non-small cell lung cancer. Both men and women can take part.
Because this is a specialised study, there will be strict medical criteria to ensure it is safe for you. For instance, doctors will review your general fitness, your organ function, and any treatments you have previously received for your cancer. Certain medical conditions or previous severe reactions to similar therapies may mean this study is not suitable for you.
Your cancer care team will need to carry out tests, such as blood checks and scans, to confirm whether your specific type of lung cancer fits the trial's requirements.
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 non-small cell lung cancer.
- My cancer has spread to other parts of my body (metastatic).
- I am well enough to attend regular hospital appointments and scans.
- I am willing to receive treatments through an intravenous drip.
What does participation involve?
If you take part, you will receive the study drugs as an intravenous infusion (a drip directly into a vein) at a hospital clinic. You will need to attend regular clinic appointments so doctors can check how you are feeling, monitor your blood pressure and heart rate, and take blood and urine samples.
You will also have routine imaging scans, such as CT or MRI scans, every few weeks or months. These scans allow the team to measure your tumour and see whether the treatment is working. Your care team will monitor you closely for any unwanted side effects throughout the study.
The total time you spend on the trial can vary. You will typically continue receiving the study treatment for as long as your cancer stays stable or improves, and as long as any side effects remain manageable. Even after treatment stops, the team will usually check in on you for follow-up appointments.
Potential risks and benefits
Locations (3)
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is the purpose of this clinical trial?
The trial aims to find out if combining two medicines (amivantamab and cetrelimab) is safe and effective for treating advanced non-small cell lung cancer.
How are the study drugs given?
Both medicines are given directly into a vein through a drip (intravenous infusion) during visits to the hospital clinic.
Will I have to pay for the trial treatment?
No. In the UK, clinical trial medicines and study-related tests are provided free of charge, though you should check if travel expenses can be reimbursed.
Can I leave the study if I change my mind?
Yes. You have the right to leave the study at any point, for any reason, and your regular medical care will continue as normal.
Will I definitely receive the new medicines?
Yes. This part of the study is testing this specific combination, so participants who join will receive the study drugs being evaluated.
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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