A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)
Small-cell lung cancer is an aggressive lung cancer. For cancer that is confined to one area in the chest, standard treatment is chemoradiotherapy, where chemotherapy and radiotherapy are given together. Although this treatment often shrinks or clears the tumour, the cancer frequently returns. This clinical trial, called the ADRIATIC study, is testing whether immunotherapy drugs can keep the cancer under control for longer. Immunotherapies work by helping your body's own immune system find and destroy cancer cells. Participants receive either durvalumab on its own, durvalumab paired with tremelimumab, or a harmless dummy medicine (a placebo). These are given through a drip into a vein. Doctors will track whether these medicines delay the cancer coming back, extend overall survival, and protect daily quality of life. The trial is open to adults whose cancer did not worsen after completing chemoradiotherapy.
At a glance
What is this study about?
Small-cell lung cancer is a fast-growing type of cancer. When doctors describe it as 'limited-stage', it means the cancer is still contained within one side of the chest and nearby lymph nodes. The standard first-line treatment is concurrent chemoradiotherapy, where chemotherapy and radiotherapy are given around the same time. While this approach often works well initially, the cancer unfortunately tends to return quickly for many people.
Researchers are investigating whether 'consolidation therapy'—extra medicine given right after successful initial treatment—can prevent or delay the cancer returning. This study tests two immunotherapy medicines called durvalumab and tremelimumab. Instead of attacking cancer cells directly, these treatments help switch on your body's natural defences so your immune system can better target remaining cancer cells.
The main aim of the trial is to discover whether taking durvalumab alone, or alongside tremelimumab, helps people stay cancer-free for longer and increases life expectancy compared to a placebo. The study also measures how these treatments affect patients' day-to-day energy, symptoms, and overall quality of life.
Key takeaways
- Tests immunotherapy drugs (durvalumab and tremelimumab) for limited-stage small-cell lung cancer.
- Aimed at adults whose cancer has not grown after chemoradiotherapy.
- Compares active immunotherapy medicines against a dummy treatment (placebo).
- Treatments are given as a drip into a vein every few weeks at a hospital clinic.
- Regular scans and health checks are carried out to monitor your safety and wellbeing.
- Taking part is completely voluntary and does not impact your normal NHS rights.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with limited-stage small-cell lung cancer. To be eligible, you must have recently completed a full course of concurrent chemoradiotherapy as your primary treatment.
Most importantly, your cancer must not have grown or spread during or immediately after your chemoradiotherapy. You also need to be reasonably active and well enough to attend hospital appointments, manage daily self-care, and undergo regular health assessments.
You will not be able to join if your cancer has already spread to distant areas of your body (extensive stage) or if scans show that the tumour continued to grow despite treatment. Your hospital specialist will review your scans, heart checks, and blood results to confirm if taking part is safe 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 18 years of age or older.
- I have been diagnosed with limited-stage small-cell lung cancer.
- I have recently finished chemotherapy and radiotherapy given together.
- My latest scans show that my cancer has shrunk or remained stable (it has not grown).
- I am well enough to carry out daily tasks and travel to regular hospital visits.
What does participation involve?
If you join, a computer will place you at random into one of three groups. You will receive either durvalumab, a combination of durvalumab and tremelimumab, or a placebo drip. This is a 'double-blind' trial, meaning neither you nor your doctor will know which treatment you are receiving, which ensures the results are completely fair.
The treatment is given as a drip into a vein (an intravenous infusion) at the hospital every few weeks. During visits, you will have routine health checks, including blood tests, physical examinations, heart traces (ECGs), and blood pressure checks. You will also have regular CT scans to see how your chest is responding and fill in short questionnaires about how you feel. Treatment may continue for up to two years, provided the medicine remains safe for you and the cancer stays under control, followed by periodic long-term check-ups.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedCzechia
- —UnverifiedPoland
Common questions
What is an immunotherapy?
Immunotherapy is a treatment that helps your own immune system recognise and attack cancer cells, rather than killing cells directly like chemotherapy.
What is a placebo and why is it used?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps doctors prove whether the real medicine genuinely provides better results.
Will I know which treatment I am receiving?
No. To keep the study fair and unbiased, neither you nor your doctors will know which treatment you get. However, doctors can find out instantly in an emergency.
How often will I need to visit the hospital?
Visits are typically every few weeks for treatment, blood tests, and scans. Your study nurse will provide a clear calendar of all appointments.
Can I leave the study if I feel it is not right for me?
Yes. You can stop taking part at any time without giving a reason, and your regular medical team will continue to look after you using standard care.
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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