A Phase 2 Randomized Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
This phase 2 clinical trial is testing a new treatment approach for adults with advanced or recurrent non-small cell lung cancer. Currently, standard first-line treatment often includes chemotherapy paired with an immunotherapy drug called nivolumab. Immunotherapy helps your own immune system recognise and attack cancer cells. In this study, researchers want to find out if adding another immunotherapy medicine, called relatlimab, makes treatment more effective. Relatlimab works in a slightly different way to boost the body's defences. Half of the participants will receive the new three-part combination, while the other half will receive standard nivolumab and chemotherapy. Doctors will monitor how well the treatment shrinks tumours, how long it keeps the cancer under control, and whether the extra medicine causes manageable side effects. This research could help doctors find more effective first-line treatments for lung cancer in the future.
At a glance
What is this study about?
Lung cancer is one of the most common cancers diagnosed in the UK. Non-small cell lung cancer is the most frequent type. When lung cancer reaches an advanced stage, or comes back after earlier treatment, it can be difficult to cure completely. Modern care focuses on slowing the disease down, shrinking tumours, and helping people live well for as long as possible.
In recent years, immunotherapy has changed how doctors treat advanced lung cancer. Medicines like nivolumab release natural 'brakes' on the immune system, encouraging your body's white blood cells to fight cancer cells. However, cancer can sometimes find ways around these treatments. Relatlimab is a newer immunotherapy drug designed to block a different immune brake, giving the immune system an extra boost when combined with existing medicines.
This study compares the effect of adding relatlimab to standard nivolumab and chemotherapy against giving standard nivolumab and chemotherapy alone. By comparing both groups directly, researchers hope to see if the extra medicine helps shrink tumours more effectively without causing too many unwanted side effects. The results will help guide future NHS treatment choices for people facing advanced lung cancer.
Key takeaways
- Testing a new drug combination for untreated, advanced non-small cell lung cancer.
- Compares relatlimab plus nivolumab and chemotherapy against nivolumab and chemotherapy alone.
- Open to adults aged 18 and over who have not had prior treatment for advanced cancer.
- All medicines are given through a drip at a specialist hospital clinic.
- Taking part is voluntary, and you can stop at any time without losing your standard care.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with advanced (stage IV) or recurrent non-small cell lung cancer. It is specifically designed for people who are ready to start their first main course of treatment for advanced cancer.
Because this is a first-line study, you generally cannot take part if you have already received chemotherapy or immunotherapy for advanced lung cancer. You will also need to be well enough in your daily life to attend regular hospital appointments and safely receive intravenous medicines.
Your study doctor will run blood tests, scans, and health checks to ensure your heart, liver, and kidneys are working well enough. If you have certain active autoimmune conditions or other serious health issues, this trial may not be 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.
- I am aged 18 or older.
- I have been diagnosed with stage IV or recurrent non-small cell lung cancer.
- I have not yet started systemic treatment (chemotherapy or immunotherapy) for advanced cancer.
- I am well enough to carry out daily activities and travel to hospital appointments.
- I am willing to have regular blood tests, intravenous drips, and imaging scans.
What does participation involve?
If you take part, you will be placed into one of two treatment groups by chance (randomly chosen by a computer). One group receives relatlimab, nivolumab, and chemotherapy. The other group receives nivolumab and chemotherapy. All medicines are given as drips into a vein (intravenous infusions) at a hospital clinic.
Treatments are usually given in cycles every few weeks. During each visit, your care team will check your blood, measure your vital signs, and ask how you are feeling. You will have regular imaging scans (such as CT scans) every few months to see how your tumour responds to the medicine.
Treatment can continue for as long as it helps you and does not cause severe side effects, often for up to one to two years. After treatment ends, the study team will continue to stay in touch with you for follow-up visits or phone calls to check on your overall health.
Potential risks and benefits
Locations (9)
- —UnverifiedPoland
- —UnverifiedIreland
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedRomania
- —UnverifiedFrance
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedItaly
Common questions
What does 'randomised' mean in this trial?
It means a computer randomly decides which treatment group you join, like rolling a dice. This ensures the comparison between the treatments is fair and unbiased.
Will I receive a placebo (dummy medicine)?
No, everyone in this trial receives active cancer treatment. Nobody receives only a dummy medicine; you will get at least standard immunotherapy plus chemotherapy.
How often will I need to visit the hospital?
You will usually visit every two to three weeks for infusions, blood tests, and health reviews. Scans take place every few months.
Can I leave the trial if I change my mind?
Yes. Joining a clinical trial is entirely voluntary. You can withdraw at any point, and your regular medical team will continue to care for you.
Will taking part cost me anything?
No. The trial medicines and required tests are provided free of charge, and many trials offer support to cover your travel expenses.
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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