RecruitingPHASE3INTERVENTIONAL

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

This research study is looking into new ways to treat non-small cell lung cancer, specifically in people whose cancer has a particular gene change called KRAS G12C mutation. The study aims to find out if combining two new medicines, calderasib and pembrolizumab, can help patients live longer without their cancer growing or spreading. Calderasib is a 'targeted therapy' designed to attack cancer cells with the KRAS G12C mutation, and pembrolizumab helps the body’s own immune system fight the cancer. This combination will be compared to a standard treatment of pembrolizumab given with chemotherapy, which is a common cancer medicine. The study will assess if the new combination offers a better outcome for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

675

Start

08 Oct 2025

Estimated completion

06 Aug 2032

Non-small Cell Lung Cancer

What is this study about?

This study is for people with a type of lung cancer called non-small cell lung cancer (NSCLC). This is the most common type of lung cancer. Researchers are particularly interested in patients whose cancer has a specific change in its genes, known as the KRAS G12C mutation. This genetic change can make cancer cells grow and spread.

The main goal of this study is to see if a new combination of treatments can work better than existing ones. The main combination being tested involves two medicines: calderasib and pembrolizumab. Calderasib is a newer 'targeted therapy' designed to specifically block the effects of the KRAS G12C mutation, while pembrolizumab is an 'immunotherapy' that helps your body's own immune system find and fight the cancer. These two medicines would be given together.

This new combination will be compared to a standard treatment approach, which involves pembrolizumab given along with chemotherapy (medicines that kill cancer cells). The researchers want to find out if patients receiving calderasib and pembrolizumab live longer without their cancer growing or spreading, compared to those receiving pembrolizumab and chemotherapy. This is a very important question as it could lead to new and more effective treatment options for people with this specific type of lung cancer.

Key takeaways

Tests new treatments for non-small cell lung cancer.
Specifically for cancer with the KRAS G12C gene change.
Compares a new drug combination to standard treatment.
Aims to see if patients live longer without cancer progression.
Participants will be closely monitored during the study.

Who may be eligible?

To join this study, you must have non-small cell lung cancer that has spread or cannot be removed by surgery or treated with radiotherapy. The cancer should not be of a type called 'small cell lung cancer'. If you have HIV, it must be under control with medication.

There are also some reasons why you might not be able to join. For example, if you've had certain other cancers recently, have serious heart or brain conditions, or an active inflammatory bowel disease like Crohn's or ulcerative colitis. If you've already received other systemic cancer treatments for your advanced lung cancer, or have specific brain tumours, you would also not be able to take part. This ensures the safety of everyone involved and that the study results are as clear as possible.

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.

Do I have non-small cell lung cancer that has spread or can't be cured by surgery/radiation?
Do I have any other active cancers that are still being treated?
Have I had other strong treatments for my advanced lung cancer already?
Do I have serious heart problems or active Inflammatory Bowel Disease?
Is my HIV well controlled if I am positive for it?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular hospital visits for assessments and to receive your study medication. The specific schedule of visits and tests (like blood tests, scans, and physical examinations) would be explained by the study team. You would receive either the new combination of calderasib and pembrolizumab or pembrolizumab and chemotherapy, depending on which group you are assigned to. Treatment would continue as long as it is helping you and you are tolerating it well. After your treatment period, there would be follow-up visits to monitor your health. The total duration of your participation would depend on how your treatment is progressing and how long your follow-up is needed, but the study team will provide more specific details.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available. However, there's no guarantee that the treatments being tested will work for you, or that they will be better than standard care. Like all medicines, the study drugs may cause side effects, which the medical team will explain in detail. Your safety is a priority, and you will be closely monitored. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (170)

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

Central Alabama Research ( Site 0108)
Verified postcode
Birmingham, United States· Recruiting
Stamford Hospital ( Site 0126)
Verified postcode
Stamford, United States· Recruiting
Mount Sinai Cancer Center ( Site 0137)
Verified postcode
Miami Beach, United States· Completed
Indiana University Health Arnett Cancer Center ( Site 0116)
Verified postcode
Lafayette, United States· Recruiting
New England Cancer Specialists ( Site 0139)
Verified postcode
Westbrook, United States· Recruiting
New York Oncology Hematology, P.C. ( Site 0119)
Verified postcode
Albany, United States· Recruiting
St. Charles Health System, Inc ( Site 0146)
Verified postcode
Bend, United States· Recruiting
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)
Verified postcode
Lancaster, United States· Recruiting
Blue Ridge Cancer Care ( Site 0144)
Verified postcode
Roanoke, United States· Recruiting
Instituto Alexander Fleming ( Site 0311)
Unverified
Ciudad Autónoma de Buenos Aires, Argentina· Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)
Verified postcode
Mar del Plata, Argentina· Recruiting
Hospital Italiano de Cordoba ( Site 0308)
Verified postcode
Córdoba, Argentina· Recruiting

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, and this study focuses on it when it has spread or can't be removed by surgery.

What is the KRAS G12C mutation?

It's a specific genetic change in cancer cells that can make them grow. Calderasib is designed to target this change.

Will I know which treatment I'm getting?

The study team will explain how treatments are assigned. Sometimes, participants and their doctors don't know to keep the study fair, but this will be made clear to you.

What are targeted therapy and immunotherapy?

Targeted therapy attacks specific features of cancer cells, while immunotherapy helps your body's immune system fight the cancer.

Can I leave the study if I want to?

Yes, you can choose to stop participating in the study at any time, and it won't affect your future medical care.

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.