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AuthorisedTherapeutic confirmatory (Phase III)Interventional

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy

This study, called ROSETTA Lung-201, is looking at a new medicine called pumitamig for people with a type of lung cancer known as unresectable Stage III non-small cell lung cancer. This means the cancer is in the chest but can't be fully removed with surgery, and it hasn't gotten worse after previous chemotherapy and radiation. The study compares pumitamig with an existing medicine called durvalumab. Doctors want to find out if pumitamig is better at stopping the cancer from growing or spreading for longer. They will also look at whether people live longer, how much tumors shrink, and any side effects of the medicines. It's a large study, involving many hospitals, and all adults are welcome to participate.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Bristol-Myers Squibb Services Unlimited Company
Enrolment target
279
Start
22 May 2026

What is this study about?

Imagine you have a type of lung cancer that’s in your chest but hasn't spread further, and it can't be completely removed by surgery. You've already had standard treatment, like chemotherapy and radiation, and the cancer seems to be under control for now. This study is for people like you.

Doctors are testing a new medicine called pumitamig. They want to see if it works better than a currently available medicine, durvalumab, at keeping the cancer from growing or coming back. Both medicines are designed to help your body fight the cancer.

The main goal is to find out if pumitamig can delay the cancer’s growth for a longer time. They will also check if people live longer, how much the tumors might shrink, and what side effects might happen with each medicine. This information helps doctors understand which treatment might be best in the future.

Key takeaways

  • Tests a new medicine (pumitamig) against current treatment (durvalumab) for a specific lung cancer.
  • For adults with Stage III non-small cell lung cancer that hasn't progressed after initial treatment.
  • Main goal is to see which medicine stops cancer growth for longer.
  • Participation involves regular hospital visits for treatment, tests, and monitoring.
  • There are potential benefits and risks, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult participants, aged 18 or older.

To be considered, you must have a specific type of lung cancer called unresectable Stage III non-small cell lung cancer. "Unresectable" means the cancer can't be completely removed by surgery because of its size or location. "Stage III" means it's in your chest but hasn't spread to distant parts of your body. You must have also completed treatment with a combination of chemotherapy and radiation therapy at the same time, and importantly, your cancer must not have grown worse since that treatment finished.

There will be other detailed medical checks to make sure this study is safe and appropriate for you, but generally, both men and women are welcome to participate.

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. Do you have a type of lung cancer called "unresectable Stage III non-small cell lung cancer"?
  3. Has your cancer not gotten worse after your chemotherapy and radiation treatment?
  4. Are you able to visit the hospital regularly for treatments and check-ups?
Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to receive either the new medicine (pumitamig) or the standard medicine (durvalumab). This means you wouldn't get to choose which one you receive, similar to flipping a coin. You wouldn't know which medicine you're getting, but your study doctor would. You would receive one of these medicines as a drip into your arm (an infusion) for a set period.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans (like CT or MRI scans) to see how the treatment is working and to monitor your health. You will also be asked about any side effects you might be experiencing. These visits will continue for as long as the treatment is helping, and then you'll enter a follow-up period where you'll have fewer visits, but doctors will still keep in touch to see how you're doing. The total length of your participation will depend on how you respond to the treatment, but follow-up can last for several years.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. You might benefit from closer medical attention and potentially receive a new treatment that could work better than current options, though there's no guarantee. However, there's also the chance you could experience side effects from the study medicines, some of which might be serious. The new medicine's full range of side effects is not yet fully known. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (14)

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

Common questions

What does 'unresectable Stage III non-small cell lung cancer' mean?

It's a type of lung cancer that's in your chest but hasn't spread further, and it can't be completely removed by surgery.

What is the new medicine being tested?

The new medicine is called pumitamig. It's being compared to an existing medicine called durvalumab.

Will I know which medicine I'm getting?

No, you'll be randomly assigned to one of the medicines, and you generally won't know which one it is. This helps make the study fair.

How often will I need to go to the hospital?

You'll have regular visits for check-ups, blood tests, and scans throughout the treatment, and then fewer visits during a follow-up period.

Can I stop participating in the study if I want to?

Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

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

Discussion

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