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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Durvalumab after concurrent platinum/etoposide chemotherapy and high-dose twice-daily thoracic radiotherapy in limited stage small cell lung cancer – an open label, randomized phase III trial (DAHRTS)

Small cell lung cancer is an aggressive form of lung cancer. When it is found in the 'limited stage', it means the cancer has not spread beyond one side of the chest. The usual treatment is a combination of chemotherapy and radiotherapy. This clinical study, called DAHRTS, is testing whether adding an immunotherapy medicine called durvalumab (Imfinzi) helps patients live longer and stay healthier. Durvalumab works by helping the body's own immune system recognise and attack cancer cells. In this trial, adults who have completed standard chemotherapy and twice-daily radiotherapy to the chest are split into groups to see if receiving durvalumab improves overall survival and keeps the cancer from growing back. Researchers will also closely monitor side effects and how the treatment affects quality of life.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Norges Teknisk-Naturvitenskapelige Universitet NTNU
Enrolment target
426
Start
17 Aug 2026

What is this study about?

Small cell lung cancer is a fast-growing type of cancer. Limited-stage means the cancer is still confined to one area of the chest, making it treatable with a combination of chemotherapy drugs and radiotherapy given at the same time. While this initial treatment often works well, the cancer frequently returns, so doctors are looking for ways to provide longer-lasting protection.

Immunotherapy is a modern type of cancer treatment. Instead of attacking the cancer directly like chemotherapy does, it helps your body's own immune system spot and destroy cancer cells. Durvalumab (also known by the brand name Imfinzi) is an approved immunotherapy drug that has shown promise in treating other forms of lung cancer.

This phase 3 clinical trial is designed to see whether giving durvalumab after standard chemotherapy and twice-daily chest radiotherapy can improve overall survival. The study will also track how long patients stay free of cancer progression, how safe the treatment is, and how it impacts day-to-day quality of life.

Key takeaways

  • Tests whether the immunotherapy drug durvalumab improves survival in limited-stage small cell lung cancer.
  • Aimed at adults who have had chemotherapy combined with twice-daily chest radiotherapy.
  • Durvalumab is given via a drip into a vein at regular hospital visits.
  • Doctors will closely monitor cancer control, side effects, and your quality of life.
  • Participation is entirely voluntary and you can withdraw at any time.

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. This means the cancer has not spread to distant parts of the body and can be treated within a single radiation area.

To be considered, patients generally need to have completed standard treatment involving chemotherapy (usually platinum and etoposide) given alongside radiotherapy to the chest. Participants must also be well enough to carry out daily activities and have adequate heart, kidney, and liver function.

People whose cancer has already spread to distant organs, or those with certain uncontrolled medical conditions, serious autoimmune illnesses, or active severe infections, are usually not able to join. Your hospital doctor or oncologist can check whether your exact medical history fits the trial guidelines.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with limited-stage small cell lung cancer.
  3. My cancer has not spread to distant parts of my body.
  4. I am planned to receive, or have received, chemotherapy alongside chest radiotherapy.
  5. I am generally well enough to manage daily self-care and attend regular clinic visits.
Answer every question to see your result.

What does participation involve?

If you join the study, you will be allocated to a treatment group. Those receiving durvalumab will have the drug given as an intravenous infusion (a drip into a vein) at a hospital clinic, typically every few weeks. Before each treatment, you will have regular safety checks including blood tests, physical examinations, and questions about how you feel. You will also have periodic CT or PET scans to see how the cancer is responding. Treatment continues for a set period or until your doctor feels it is best to stop. After treatment finishes, the research team will stay in touch for regular check-ups to monitor your long-term health and wellbeing.

Potential risks and benefits

Taking part may help keep your cancer under control for longer, and the findings could help future patients facing the same condition. However, there is no guarantee you will personally benefit. Durvalumab can cause side effects because it activates the immune system; these may include tiredness, skin rashes, cough, or inflammation in organs such as the lungs, bowels, or liver. Your care team will monitor you closely to manage any symptoms quickly. Taking part is completely voluntary, and you are free to leave the trial at any time without it affecting your standard NHS care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Denmark
  • —
    Unverified
    Finland
  • —
    Unverified
    Estonia
  • —
    Unverified
    Germany
  • —
    Unverified
    Lithuania
  • —
    Unverified
    Sweden
  • —
    Unverified
    Norway
  • —
    Unverified
    Netherlands

Common questions

What is the main aim of this study?

The main goal is to find out if adding the immunotherapy drug durvalumab helps patients with limited-stage small cell lung cancer live longer compared to standard care alone.

How is durvalumab given?

Durvalumab is given as a liquid through a drip directly into a vein (an intravenous infusion), usually taking about an hour at a hospital day unit.

What does 'phase 3' mean?

Phase 3 trials compare a promising new treatment against the current standard care in a large group of people to confirm whether it is safe and truly effective.

Will I have to pay for the trial treatment?

No, clinical trial medicines in the UK are provided free of charge, and taking part will not cost you anything.

Can I stop taking part if I change my mind?

Yes. You have the right to withdraw from the trial at any time, for any reason, and your medical team will continue to provide you with the best available standard treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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