RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)

This study, called ROSETTA Lung-202, is for people with advanced non-small cell lung cancer that hasn't been treated previously. It’s comparing a new drug, Pumitamig, with a standard treatment, Pembrolizumab. Doctors are interested in how well Pumitamig works for patients whose cancer cells show a high level (50% or more) of a specific protein called PD-L1. This protein can help predict how well certain immune-boosting therapies might work. The study is in Phase 3, meaning it's a large trial to see if the new treatment is better or as good as current options, and to check for its safety. It aims to find better ways to treat this type of lung cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

750

Start

12 Mar 2026

Estimated completion

14 Oct 2031

Non-Small Cell Lung Cancer (NSCLC)

What is this study about?

This study is a Phase 3 trial looking into a new medicine called Pumitamig for people who have advanced non-small cell lung cancer that has not been treated with anti-cancer drugs before. Non-small cell lung cancer is the most common type of lung cancer. 'Advanced' means the cancer has spread or is difficult to remove with surgery. The trial is comparing Pumitamig with a standard treatment, Pembrolizumab, which is currently used to treat this type of cancer.

The main goal of this research is to see how effective Pumitamig is in shrinking tumours or slowing cancer growth, especially in patients whose cancer cells have a high level (50% or more) of a marker called PD-L1. PD-L1 is a protein found on cancer cells that can influence how the immune system reacts to the cancer. Treatments that target PD-L1 or related pathways are a type of immunotherapy, which helps your body's own immune system fight cancer.

By comparing Pumitamig to an established treatment like Pembrolizumab, the researchers hope to understand if Pumitamig could offer a new, effective treatment option for suitable patients with advanced non-small cell lung cancer. This could potentially improve outcomes for people living with this condition.

Key takeaways

This study is for advanced non-small cell lung cancer that hasn't been treated yet.
It compares a new drug, Pumitamig, to a standard drug, Pembrolizumab.
It's for people whose cancer has high levels of a marker called PD-L1.
This is a Phase 3 trial, a key step in testing new treatments.
The goal is to find better treatment options for this type of lung cancer.

Who may be eligible?

To join this study, you would typically need to have been diagnosed with advanced non-small cell lung cancer (either Stage IIIB/IIIC or Stage IV) that hasn't been treated with other anti-cancer medicines yet. Your cancer cells must also show a high level (50% or more) of a specific marker called PD-L1, which doctors will check from a tissue sample. You also need to have cancer that can be measured easily by scans.

There are also some reasons why you might not be able to join. For example, if your cancer has certain genetic changes for which other approved treatments are available, or if you have specific serious heart problems, active autoimmune diseases, or untreated brain or spine metastases. The study team will review your full medical history to make sure it's safe for you 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.

I have advanced non-small cell lung cancer (Stage IIIB/IIIC or Stage IV).
My cancer has not been treated with anti-cancer medicines before.
My cancer cells show high levels (50% or more) of the PD-L1 marker.
I do not have specific genetic changes in my cancer for which other treatments are already approved.
I do not have serious uncontrolled heart conditions or specific types of brain or spinal cord cancer spread.

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for assessments, including physical examinations, blood tests, and scans (like CT or MRI). You would receive either the new drug, Pumitamig, or the standard drug, Pembrolizumab, which would likely be given intravenously (into a vein). The study team will monitor you closely for any side effects and to see how your body is responding to the treatment.

The frequency and duration of these visits, as well as any follow-up appointments after treatment, would be clearly explained by the study team. You would also have regular contact with the study doctors and nurses who can answer any questions you have.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. However, there are also potential risks, as new medicines can have side effects that are not yet fully known. Pembrolizumab, the standard treatment, also has known side effects, which the study team will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (273)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Southern Cancer Center Pc
Verified postcode
Daphne, United States· Recruiting
Local Institution - 0424
Verified postcode
Bullhead City, United States· Not yet recruiting
Local Institution - 0391
Verified postcode
Glendale, United States· Not yet recruiting
Local Institution - 0407
Verified postcode
Anaheim, United States· Not yet recruiting
Local Institution - 0352
Verified postcode
Beverly Hills, United States· Not yet recruiting
Orange Coast Memorial Medical Center
Verified postcode
Fountain Valley, United States· Recruiting
Local Institution - 0027
Verified postcode
Los Alamitos, United States· Not yet recruiting
Local Institution - 0422
Verified postcode
Los Angeles, United States· Not yet recruiting
Local Institution - 0403
Verified postcode
Oakland, United States· Not yet recruiting
Local Institution - 0208
Verified postcode
Pleasant Hill, United States· Not yet recruiting
Local Institution - 0416
Verified postcode
Walnut Creek, United States· Not yet recruiting
Local Institution - 0340
Verified postcode
Lakewood, United States· Not yet recruiting

Common questions

What is PD-L1?

PD-L1 is a protein that can be found on cancer cells. Its level can help doctors understand if certain immune-boosting treatments, called immunotherapies, might work well for your cancer.

What does 'advanced' non-small cell lung cancer mean?

Advanced means the cancer has spread to other parts of the body (Stage IV) or is locally advanced (Stage IIIB/IIIC) and cannot be easily removed with surgery.

What is a Phase 3 study?

A Phase 3 study is a large-scale research trial that compares a new treatment to an existing standard treatment to see if it's better or at least as good, and to gather more information on its safety.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to receive either the new drug or the standard drug. Sometimes you and your doctor won't know which treatment you are receiving until after the study is over, which helps ensure the results are fair.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your standard medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

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