RecruitingPHASE3INTERVENTIONAL

MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)

This research study is for people in the UK who have had a specific type of non-small cell lung cancer removed by surgery. This cancer must have a particular genetic change called KRAS G12C. The study is comparing two treatment combinations to see which is better at preventing the cancer from returning. One combination is a new drug called Calderasib, given alongside an existing treatment called MK-3475A. The other combination is a dummy treatment (placebo) given alongside MK-3475A. Participants will be randomly assigned to one of these groups, and neither they nor their doctors will know which treatment they are receiving until the end of the study. This is a Phase 3 study, meaning it's a large trial testing if a new treatment is better than existing options.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

400

Start

18 Mar 2026

Estimated completion

26 Oct 2039

Non-small Cell Lung Cancer

What is this study about?

This clinical trial is designed to investigate a new treatment approach for a specific type of lung cancer. The full name of the cancer is 'non-small cell lung cancer', and it's a particular kind that has a genetic change called KRAS G12C. This study is for people whose cancer has been completely removed by surgery. The main goal is to see if adding a new drug, called Calderasib, to an existing medicine (MK-3475A) helps prevent the cancer from coming back.

MK-3475A is a medicine that helps the body's immune system fight cancer. Calderasib is a different type of drug that targets the specific KRAS G12C genetic change in cancer cells. Researchers want to compare what happens when people receive Calderasib plus MK-3475A, versus when they receive a dummy treatment (called a placebo) plus MK-3475A. By comparing these two groups, doctors can understand if adding Calderasib is more effective at keeping the cancer away.

This is a 'Phase 3' study, which means it's a large-scale trial. These studies are crucial for testing whether new treatments are safe and work better than what's currently available. All participants will be checked regularly to see if the cancer returns. The study hopes to find a new way to improve outcomes for people with this specific form of lung cancer after surgery.

Key takeaways

This study is for a specific type of lung cancer (KRAS G12C non-small cell lung cancer) after surgery.
It tests if adding a new drug, Calderasib, helps prevent cancer from coming back.
Participants will receive either Calderasib + MK-3475A or a dummy treatment (placebo) + MK-3475A.
It's a large, important 'Phase 3' study.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to have a specific type of lung cancer called non-small cell lung cancer that has a particular genetic change called KRAS G12C. Your cancer must have been completely removed by surgery. This surgery must have happened recently, generally within 12 weeks of starting the study treatment. You also need to be generally well enough to take part, as assessed by your doctor.

There are certain conditions that would prevent you from joining. For example, if your cancer is a different type (like small cell lung cancer) or if you have specific other health issues, such as active infections like untreated Hepatitis B or C, or certain types of HIV-related conditions. The study team will review all your medical information carefully to see if you are a good fit.

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 had non-small cell lung cancer completely removed by surgery?
Does your cancer have the specific 'KRAS G12C' genetic change?
Was your surgery recent (generally within the last 12 weeks)?
Are you 18 years old or older?
Are you generally well enough to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two treatment groups. This is like flipping a coin – you'll have an equal chance of receiving either Calderasib plus MK-3475A, or a dummy treatment (placebo) plus MK-3475A. Neither you nor your study doctor will know which treatment you are receiving until the study ends. You will receive MK-3475A as an injection under the skin, and Calderasib or the placebo as tablets.

Taking part will involve regular visits to the clinic for check-ups, blood tests, and scans (like CT scans) to monitor your health and see if the treatment is working. The study team will provide more details about the schedule of these visits. The total duration of your participation, including treatment and follow-up, will be explained fully by the study staff.

Potential risks and benefits

Participating in a clinical trial might offer potential benefits, such as access to a new experimental treatment that is not yet widely available. However, there is no guarantee that the treatment will help you, and it might not be better than standard care. All medicines can have side effects, and the new treatments in this study might cause unexpected ones. The study team will monitor you closely for any side effects and provide care. It's important to understand the potential risks and discomforts involved. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (95)

Instituto Alexander Fleming ( Site 0310)
City only
Ciudad Autónoma de Buenos Aires, Argentina· Recruiting
Sanatorio Parque ( Site 0311)
Verified postcode
Rosario, Argentina· Recruiting
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0306)
City only
CABA, Argentina· Recruiting
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309)
City only
CABA, Argentina· Recruiting
Northern Beaches Hospital ( Site 3009)
Verified postcode
Frenchs Forest, Australia· Recruiting
Peninsula University Hospital ( Site 3011)
Verified postcode
Frankston, Australia· Recruiting
PRONUTRIR ( Site 0425)
Verified postcode
Fortaleza, Brazil· Recruiting
Faculdade de Medicina do ABC ( Site 0415)
Verified postcode
Santo André, Brazil· Recruiting
Hospital Alemao Oswaldo Cruz ( Site 0416)
Verified postcode
São Paulo, Brazil· Recruiting
Moncton Hospital ( Site 0200)
Verified postcode
Moncton, Canada· Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0219)
Verified postcode
Montreal, Canada· Recruiting
Centro de Oncología de Precisión-Oncology ( Site 0503)
Verified postcode
Las Condes, Chile· Recruiting

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, and this study focuses on a specific form of it that has a particular genetic change.

What does 'KRAS G12C' mean?

This refers to a specific genetic change, or mutation, found in some cancer cells. The new drug, Calderasib, is designed to target this particular change.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the new treatment.

What does 'randomised and double-blind' mean?

Randomised means you're assigned to a treatment group by chance. Double-blind means neither you nor your doctors will know which treatment you're getting, to keep the study fair.

Can I stop participating in the study if I change my mind?

Yes, you can choose to leave the study at any point, and it will not affect the medical care you receive.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

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