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AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer who are ctDNA-positive or Have High-risk Pathological Features (TROPION Lung12)

This important study, named TROPION Lung12, is looking for better ways to prevent lung cancer from returning in patients who have had surgery. Specifically, it's for people with a type of lung cancer called Stage I adenocarcinoma non-small cell lung cancer. The study is particularly interested in those whose cancer cells show certain features, either a 'ctDNA-positive' result or other 'high-risk pathological features'. Patients taking part will compare new treatment options: a combination of Datopotamab Deruxtecan (Dato-DXd) and Rilvegostomig, or Rilvegostomig by itself, against the standard treatments currently used. Scientists want to see which treatment is most effective at keeping the cancer away after surgery, and also how these treatments affect patients' quality of life and general well-being. This is a Phase III study, meaning it's a large trial to confirm if new treatments are better than existing ones.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
AstraZeneca AB
Enrolment target
119
Start
17 Feb 2025

What is this study about?

When lung cancer is found at an early stage, surgery is often the best way to remove the cancer cells. However, even after successful surgery, there's always a chance that some tiny cancer cells might be left behind, which could cause the cancer to return later. This is why doctors sometimes recommend additional treatment after surgery, known as 'adjuvant therapy', to try and kill any remaining cancer cells and reduce the risk of the cancer coming back.

This study, called TROPION Lung12, is focusing on a specific type of early-stage lung cancer called Stage I adenocarcinoma non-small cell lung cancer. Researchers are particularly interested in patients whose cancer has certain characteristics that might make it more likely to return. These characteristics include a positive 'ctDNA' test result, which looks for tiny fragments of cancer DNA in the blood, or other ‘high-risk pathological features’ seen when the cancer tissue is examined under a microscope after surgery.

The main goal of this study is to find out if new treatments are better than current standard care at stopping the cancer from returning. Patients in the study will be divided into groups to receive either a new drug combination (Datopotamab Deruxtecan with Rilvegostomig), Rilvegostomig on its own, or treatments that are considered standard care. Researchers will carefully track how long patients remain free from their cancer and also look at overall survival and how treatments affect daily life and well-being. This research could lead to new, more effective ways to help people stay cancer-free after surgery.

Key takeaways

  • This study explores new treatments for early-stage lung cancer after surgery.
  • It targets patients with specific markers indicating a higher risk of cancer recurrence.
  • The goal is to find better ways to prevent the cancer from coming back.
  • You might receive new drugs or standard care, chosen randomly.
  • Participation involves regular check-ups and monitoring.
  • This is a Phase III study, aiming to confirm treatment effectiveness.

Who may be eligible?

To be able to join this study, you would need to be an adult, aged 18 or over. This study is open to both men and women.

Crucially, you must have been diagnosed with Stage I adenocarcinoma non-small cell lung cancer, and you must have had surgery to completely remove the tumour. The doctors will also check specific features of your cancer that suggest a higher risk of it coming back. This could be a special blood test called a 'ctDNA test' showing positive results, or certain characteristics found when your tumour was examined after surgery.

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. Are you 18 years old or older?
  2. Have you been diagnosed with Stage I adenocarcinoma non-small cell lung cancer?
  3. Have you had surgery to completely remove your lung tumour?
  4. Do your doctors believe your cancer has specific features (like a positive ctDNA test or high-risk features) that make it more likely to return?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of several treatment groups. This means you might receive the new drug combination, one of the new drugs alone, or the standard treatment currently used for your type of cancer. You would attend regular appointments for assessments, which could include blood tests, scans, and questionnaires about how you are feeling and your quality of life. The treatments would be given according to a specific schedule, decided by the study doctors.

Throughout the study, you would be closely monitored by the medical team. They would keep a careful eye on your health, any side effects you might experience, and the progress of your cancer. The total duration of your participation would depend on your treatment group and the study's follow-up plan, but it generally involves regular check-ups over an extended period to track long-term outcomes.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive new treatments that are not yet widely available, and you would be closely monitored by a specialist medical team. These new treatments might be more effective than current options, potentially helping to prevent your cancer from returning. However, as with all medications, there's a possibility of side effects, and the new treatments might not work for everyone. The specific risks and benefits would be thoroughly explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Netherlands
  • Unverified
    Spain
  • Unverified
    Hungary
  • Unverified
    Germany
  • Unverified
    France
  • Unverified
    Italy
  • Unverified
    Sweden
  • Unverified
    Poland
  • Unverified
    Belgium

Common questions

What does 'Stage I adenocarcinoma non-small cell lung cancer' mean?

It means you have a common type of lung cancer that is found at an early stage and has not spread widely beyond the lung.

What is 'ctDNA-positive'?

It means a special blood test has found tiny pieces of cancer DNA in your blood, which might suggest a higher risk of your cancer returning.

What are 'high-risk pathological features'?

These are specific characteristics seen when your tumour is examined under a microscope, which doctors believe could increase the chance of the cancer coming back.

What is 'standard of care'?

This refers to the best treatments currently available and widely accepted for your condition, based on scientific evidence.

What does 'adjuvant' mean in this context?

It means the treatment is given after the main treatment (surgery, in this case) to help prevent the cancer from returning.

How to find out more

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

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