A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)
This study, called ROSETTA Lung-220, is for people recently diagnosed with early-stage non-small cell lung cancer that doctors believe can be fully removed with an operation. The main goal is to check the safety of a new medicine, Pumitamig, when given before surgery. Researchers also want to see if this treatment, often combined with standard chemotherapy drugs like Carboplatin or Paclitaxel, is well-tolerated and helps make surgery successful. This is a Phase 2 trial, which means it’s still an early stage of testing, focusing on safety and whether the treatment shows promise. It's an important step in finding better ways to treat lung cancer.
At a glance
What is this study about?
This clinical trial, known as ROSETTA Lung-220, is designed for individuals recently diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC). This study focuses on people whose cancer is in its early stages and where doctors believe it can be successfully removed through an operation. The main purpose is to explore a new way of treating this cancer by giving a medicine called Pumitamig *before* surgery. This new treatment will often be combined with other standard chemotherapy drugs that are already used for lung cancer.
The research team wants to carefully check if giving Pumitamig and chemotherapy before surgery is safe for patients and if people can tolerate the treatment well. They also want to see if this approach helps make the surgery easier or more effective. By studying this, doctors hope to find out if this combination treatment could become a valuable new option for patients with early-stage lung cancer.
This is a 'Phase 2' study, which means it's an earlier stage of research. It's about gathering more information on the safety and potential benefits of this new treatment before it's tested on a much larger group of people. The ultimate goal is to improve treatments and outcomes for those affected by non-small cell lung cancer.
Key takeaways
- This study is for early-stage lung cancer that can be operated on.
- It's testing a new drug, Pumitamig, usually with chemotherapy, before surgery.
- The main goals are to check safety and how well people tolerate the new treatment.
- It's a 'Phase 2' study, an early step in finding better treatments.
- Participation includes regular clinic visits, scans, and blood tests.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult (18 or older) who has recently been diagnosed with non-small cell lung cancer. Your cancer should be in an early stage (doctors call this Stage IIA to IIIB (N2)) and doctors must believe it can be completely removed by surgery. You also need to be generally well enough to take part, meaning you can carry out most of your daily activities without much trouble.
There are also some reasons why you might not be able to join. For example, if your cancer has spread to distant parts of your body, or if you have certain other serious health conditions like an active autoimmune disease (where your body attacks itself), severe heart problems, or certain lung diseases. If you've already had cancer treatment for your lung cancer, such as chemotherapy or radiotherapy, you usually can't join this particular study. The doctors and study team will check all these details carefully to make sure the study is right for you and safe.
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 you been diagnosed with non-small cell lung cancer?
- Is your cancer in an early stage and thought to be removable by surgery?
- Are you 18 years old or older?
- Are you generally well enough for daily activities?
- Have you not had previous cancer treatment (chemo or radio) for your lung cancer?
- Do you not have other serious health problems like severe heart or autoimmune disease?
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, Pumitamig, along with other standard chemotherapy drugs. These treatments will be given over a period of time *before* your planned surgery to remove the lung cancer. You will have regular visits to the hospital or clinic to receive your treatments, and to have various tests, such as blood tests, scans (like CT scans), and physical examinations. These tests help the doctors keep track of how you're doing, how the treatment is affecting your body, and how your cancer is responding.
After your surgery, you will continue to have follow-up appointments. These visits are important to monitor your recovery, check for any side effects, and see how you are doing in the longer term. The total duration of your participation in the study, including treatment and follow-up, will be explained fully by the study team.
Potential risks and benefits
Locations (50)
- Local Institution - 0069Verified postcodeLong Beach, United States
- Local Institution - 0127Verified postcodeLos Angeles, United States
- Local Institution - 0136Verified postcodeTampa, United States
- Local Institution - 0155Verified postcodeChicago, United States
- Local Institution - 0080Verified postcodeChestnut Hill, United States
- Local Institution - 0163Verified postcodePortland, United States
- Local Institution - 0132Verified postcodePittsburgh, United States
- Local Institution - 0185Verified postcodeNashville, United States
- Local Institution - 0112Verified postcodeHouston, United States
- Local Institution - 0023Verified postcodeWoolloongabba, Australia
- Local Institution - 0211Verified postcodeFitzroy, Australia
- Local Institution - 0009Verified postcodeMurdoch, Australia
Common questions
What is Pumitamig?
Pumitamig is an investigational medicine being tested in this study. It's a new type of drug that aims to help treat lung cancer, but we are still learning exactly how it works and its full effects.
What does 'early-stage' lung cancer mean?
Early-stage lung cancer means the cancer is localised and hasn't spread widely, making it more likely that surgery can successfully remove it. This study is for specific early stages where surgery is usually an option.
What is chemotherapy, and why is it given with Pumitamig?
Chemotherapy uses powerful medicines to kill cancer cells. In this study, standard chemotherapy drugs are given alongside Pumitamig to see if the combination works better than either treatment alone, especially before surgery.
What is a 'Phase 2' trial?
A Phase 2 trial is an early stage of research. It's mainly focused on understanding if a new treatment is safe and if it shows early signs of working, usually in a smaller group of people, before testing it more widely.
Will I still have surgery if I join this study?
Yes, this study is specifically designed for people who are expected to have surgery to remove their lung cancer. The Pumitamig-based treatment is given *before* your operation.
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?
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