A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
This study, called ROSETTA Lung-201, is trying to find out if a new medicine called pumitamig is better or worse than a standard medicine called durvalumab. Both medicines are given after chemotherapy and radiation treatment for a specific type of lung cancer called non-small cell lung cancer (NSCLC). This is for people whose cancer is Stage III, meaning it has spread locally but not to distant parts of the body, and cannot be completely removed by surgery. The study aims to see which treatment helps patients most after their initial cancer therapy.
At a glance
What is this study about?
This study is for people who have a specific type of lung cancer called non-small cell lung cancer (NSCLC). If your cancer is at Stage III, it means it has grown into nearby tissues but hasn't spread widely in your body, and doctors have decided it can't be fully removed with an operation. Before joining this study, participants would have already completed a combination of chemotherapy and radiation treatment. This combined treatment is often called chemoradiation therapy.
The main goal of this study is to compare two different medicines given after this initial treatment. One medicine is called pumitamig, which is being tested to see how well it works. The other medicine is durvalumab, which is a treatment often used in this situation and is considered a standard care option. By comparing these two, researchers hope to find out which one is more effective at helping people after their first round of treatment.
Taking part in a study like this helps doctors learn more about cancer treatments. It allows them to understand if new medicines are safe and if they work better than existing ones. The information gathered from this study could help improve the care for many people with this type of lung cancer in the future.
Key takeaways
- Compares a new lung cancer medicine (pumitamig) to a standard one (durvalumab).
- For Stage III non-small cell lung cancer that can't be removed by surgery.
- Patients must have completed chemotherapy and radiation previously.
- Aims to find the most effective treatment after initial therapy.
- Close medical monitoring and regular check-ups are part of participation.
Who may be eligible?
To be considered for this study, you must have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is Stage III and cannot be removed by surgery. You must have already completed at least two cycles of chemotherapy combined with radiation treatment, and your cancer should not have gotten worse after this treatment.
Important health checks include being generally well and able to carry out most daily activities, as measured by a score of 0 or 1 on a performance status scale. If you have a non-squamous type of NSCLC, your doctors will check for certain gene changes (called EGFR and ALK) which, if present, would mean you can't join this study. You also shouldn't have an active problem with your immune system attacking your own body (autoimmune disease).
Additionally, you shouldn't have severe heart problems, significant lung disease (like severe scarring or inflammation), or a history of specific bleeding or clotting issues. You also should not have received any previous cancer treatment for your Stage III lung cancer other than the chemotherapy and radiation therapy mentioned earlier. The study is open to both men and women aged 18 and over.
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.
- Have I been diagnosed with non-small cell lung cancer (NSCLC) at Stage III that can't be surgically removed?
- Have I already finished at least two cycles of chemotherapy combined with radiation for my cancer, and my cancer has not gotten worse since then?
- Am I generally well enough to do most of my daily activities without much trouble?
- Do I have any severe heart or lung problems, or an active autoimmune disease?
- Have I had any other cancer treatment for my Stage III lung cancer besides chemotherapy and radiation?
- Am I at least 18 years old?
What does participation involve?
If you decide to take part in this study, you'll be assigned to receive either pumitamig or durvalumab after your main cancer treatment. You would have regular appointments for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor your health. These visits would involve doctors and nurses checking for any side effects and making sure you're doing okay.
You'll be expected to take the study medicine as directed. The total duration of your participation, including the treatment period and any follow-up visits, will be explained in detail by the study team. You'll continue to be monitored even after your treatment period ends to track your long-term health. All specific details about the frequency of visits, types of tests, and duration of the study will be given to you by the study doctor. You'll always have the right to ask questions and discuss any concerns.
Potential risks and benefits
Locations (255)
- Southern Cancer Center PcVerified postcodeDaphne, United States· Recruiting
- Local Institution - 0780Verified postcodeChandler, United States· Not yet recruiting
- Local Institution - 0585Verified postcodeGolden, United States· Not yet recruiting
- Medical Oncology Hematology Consultants, PAVerified postcodeNewark, United States· Recruiting
- Local Institution - 0711Verified postcodeOcala, United States· Not yet recruiting
- Local Institution - 0756Verified postcodeMarietta, United States· Not yet recruiting
- Local Institution - 0398Verified postcodeChicago, United States· Not yet recruiting
- Local Institution - 0850Verified postcodeEvanston, United States· Not yet recruiting
- Illinois Cancer CareVerified postcodePeoria, United States· Recruiting
- Fort Wayne Medical Oncology and HematologyVerified postcodeFort Wayne, United States· Recruiting
- Local Institution - 0656Verified postcodeLexington, United States· Not yet recruiting
- Local Institution - 0603Verified postcodeBoston, United States· Not yet recruiting
Common questions
What is Stage III non-small cell lung cancer?
Stage III non-small cell lung cancer means the cancer has grown into nearby tissues or lymph nodes but hasn't spread to distant parts of your body. Doctors might say it's 'unresectable' if it can't be completely removed by surgery.
What is 'concurrent chemoradiation therapy'?
This is a treatment where you receive chemotherapy (medicine to kill cancer cells) and radiation therapy (high-energy rays to kill cancer cells) at the same time.
What are pumitamig and durvalumab?
These are both medicines used to treat cancer. Durvalumab is an established treatment, and pumitamig is a new medicine being tested to see how it compares.
Will I know which treatment I'm getting?
Sometimes in studies like this, you won't know if you're getting the new medicine or the standard one until the study is over. This helps researchers compare the treatments fairly. The study team will explain this to you.
What does 'ECOG performance status 0 or 1' mean?
This is a way doctors measure how well you're feeling and able to do daily activities. A score of 0 means you're fully active, and 1 means you're restricted in strenuous activity but can still walk around and do light work.
How to find out more
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.