Platform study Kaleidoscope: A Phase 1/2 Open-label Platform Study to Evaluate the Safety and Efficacy of Multiple Amivantamab-based Therapeutic Combinations in Participants with Advanced, Unresectable Lung Cancer (LC) ISA1 METalmark (now closed in UK): A phase I/II open-label platform study to evaluate the safety and efficacy of multiple amivantamab-based therapeutic combinations in participants with advanced, unresectable lung cancer ISA2 Polydamas: A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer ISA3 SwalloWTail: A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Docetaxel Combination Therapy in Metastatic Non-small Cell Lung Cancer
Non-small cell lung cancer is the most common type of lung cancer. When it spreads, usual treatments may stop working well. The Kaleidoscope study tests whether combining a targeted drug called amivantamab with other cancer medicines can help. Amivantamab is designed to attach to two proteins on cancer cells to stop them growing. The study has different treatment arms. While the first arm is now closed in the UK, two arms remain active. One arm tests amivantamab alongside an immunotherapy drug called cetrelimab. Another arm pairs amivantamab with a standard chemotherapy medicine named docetaxel. Doctors want to find the safest doses and see how well these combinations shrink tumours. Taking part involves having treatments through a drip at a hospital clinic, with regular blood tests, heart checks, and scans to monitor your health and response to treatment.
At a glance
What is this study about?
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer. In many patients, the cancer cells carry specific genetic changes that help the tumour grow and survive. When the cancer has spread to other parts of the body or cannot be removed with surgery, doctors look for new treatment options, especially if earlier therapies have stopped working.
This trial, called Kaleidoscope, is a 'platform study'. This means it tests several different treatment combinations under one main project. The central medicine is amivantamab. Amivantamab is a targeted therapy known as a bispecific antibody. It works like a guided missile, locking onto two specific proteins on the surface of cancer cells (EGFR and MET) to switch off their growth signals and help the immune system destroy them.
The trial is exploring whether amivantamab works better when combined with other cancer medicines. One sub-study combines it with an immunotherapy drug called cetrelimab, which helps the body's own immune system attack cancer. Another sub-study combines amivantamab with docetaxel, a well-known chemotherapy drug. A previous branch using a tablet called capmatinib has closed in the UK, but the other branches are open to eligible patients.
By testing these pairings in small groups first, doctors can find the safest dose levels. They then give these doses to larger groups to see how well they control the disease. The ultimate aim is to discover more effective, personalised treatment paths for people living with advanced lung cancer.
Key takeaways
- Tests combinations of the targeted medicine amivantamab with immunotherapy or chemotherapy.
- Open to adults with advanced non-small cell lung cancer that cannot be removed by surgery.
- The METalmark arm is closed in the UK, but two other arms remain active at specialist centres.
- Medicines are given through a drip at regular hospital visits every two to three weeks after the initial doses.
- Participation is voluntary and you are free to leave the trial at any time.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with advanced non-small cell lung cancer that cannot be removed by surgery and has spread to other areas of the body.
Because this study looks at specific drug combinations, each active group has different requirements. For example, one group is designed for people whose tumours have certain genetic markers (such as EGFR mutations) or high levels of a protein called PD-L1. Another group is open to people whose cancer has grown after receiving standard chemotherapy and immunotherapy.
You cannot join the first arm (METalmark) in the UK because it has closed. To join the remaining groups, you must be well enough to attend regular hospital appointments, have acceptable blood and organ test results, and agree to use effective contraception during the study.
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 cannot be removed by surgery.
- My cancer has progressed after previous treatment, or my tumour has specific markers (like EGFR or PD-L1).
- I am well enough to travel to a trial hospital for regular tests and infusions.
What does participation involve?
If you take part, your treatment will depend on which study branch is the best fit for your cancer. Both amivantamab and the partner drugs (cetrelimab or docetaxel) are given as an infusion into a vein through a drip. During the first few weeks, hospital visits may be weekly, and then usually reduce to once every two or three weeks.
You will have regular check-ups including blood tests, physical exams, heart tracings (ECGs), and imaging scans (such as CT or MRI scans) to check if your tumour is responding. You will also receive medicines beforehand, such as paracetamol and antihistamines, to help prevent reactions to the drip.
Your participation can last anywhere from roughly 16 months to 3 years, provided the treatment is helping you and the side effects are manageable. You will also have a safety follow-up visit about 30 days after your final dose.
Potential risks and benefits
Locations (5)
- Royal Marsden HospitalUnverifiedSutton, England
- Freeman Road HospitalUnverifiedNewcastle upon Tyne, England
- Imperial College London and Imperial College Healthcare NHS TrustUnverifiedLondon, England
- St James HospitalUnverifiedSouthsea, England
- St James' S University HospitalUnverifiedLeeds, England
Common questions
Is this trial currently open to new patients in the UK?
Yes, but only certain branches. The METalmark branch is closed in the UK, but the Polydamas and SwalloWTail branches have been recruiting at selected UK hospitals.
How are the study medicines given?
All medicines in the active UK arms are given through a drip directly into a vein at the hospital clinic.
Will taking part cost me anything?
No. The study drugs and extra medical tests are provided free of charge. Travel and parking costs related to study visits are usually reimbursed.
What happens if I experience unpleasant side effects?
The trial doctors can give you treatments to relieve symptoms, temporarily pause your treatment, or lower the dose. You can also choose to stop the trial at any point.
Do I have to stop seeing my usual cancer specialist?
No. The trial team works closely with your local care team to make sure your overall health needs continue to be met.
How to find out more
Nicola Hall
Always speak to your GP or specialist before deciding to take part in a study.
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