RecruitingPHASE3INTERVENTIONAL

A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

This research is looking for new ways to treat a specific type of locally advanced non-small cell lung cancer (NSCLC). This is lung cancer that has not spread widely but can't be removed by surgery, and it has a particular gene change called KRAS G12C. Doctors want to see if a new medication called calderasib, given along with an existing immunotherapy drug called durvalumab, works better than durvalumab alone. This treatment would be for people who have already had chemotherapy and radiation therapy. The main goal is to find out if this combination helps people live longer without their cancer growing or spreading.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

310

Start

18 Jun 2026

Estimated completion

17 Aug 2037

Non-small Cell Lung Cancer

What is this study about?

Doctors are always searching for better ways to treat cancer. This particular study focuses on a type of lung cancer called non-small cell lung cancer (NSCLC), which is quite common. Specifically, it's for people whose cancer is considered 'locally advanced' – meaning it's grown in the lung or nearby but hasn't spread to distant parts of the body, and it can't be removed by surgery. This cancer also needs to have a specific change in its genes called 'KRAS G12C', which doctors can test for.

The study is testing two medicines together: calderasib and durvalumab. Calderasib is a new drug being looked at, and durvalumab is an 'immunotherapy' drug, which works by helping your body's own immune system fight the cancer. Participants in the study will have already finished their standard treatment of chemotherapy and radiation therapy. Researchers want to compare what happens when people receive calderasib plus durvalumab, versus when they receive a dummy treatment (placebo) plus durvalumab.

The main aim is to see if adding calderasib to durvalumab can stop the cancer from growing or spreading for longer, compared to just having durvalumab alone. By doing this research, doctors hope to find a more effective treatment option for people with this specific type of lung cancer in the future.

Key takeaways

This study is for a specific type of lung cancer (NSCLC) that can't be surgically removed and has a KRAS G12C gene change.
It tests a new drug (calderasib) with an immunotherapy (durvalumab) after chemotherapy and radiation.
The goal is to see if the combination helps people live longer without their cancer growing.
You would receive either calderasib + durvalumab or a dummy pill (placebo) + durvalumab.
Participation involves regular visits, medication, and close monitoring by doctors.
You can stop participating in the study at any time.

Who may be eligible?

To be considered for this study, you would need to have a specific type of non-small cell lung cancer that is locally advanced and couldn't be removed with surgery. It also needs to have a particular genetic change called KRAS G12C, which will be checked from a sample of your tumour. You must have recently completed standard chemotherapy and radiation treatment for your lung cancer, and your cancer shouldn't have gotten worse during that time. You also need to be at least 18 years old.

There are also some reasons why you might not be able to join. For example, if you have a different type of lung cancer, or if you've had other cancer treatments for your lung cancer before (apart from the recent chemotherapy and radiation). Certain serious heart problems, active autoimmune diseases (where your body attacks itself), or other uncontrolled health issues might also mean you can't take part. It's important that you're able to swallow medication, as one of the study drugs is taken by mouth.

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 locally advanced non-small cell lung cancer that cannot be removed by surgery?
Has my doctor confirmed that my cancer has the KRAS G12C gene change?
Have I recently finished chemotherapy and radiation therapy for my lung cancer?
Am I able to swallow medication taken by mouth?
Do I have any serious, uncontrolled health problems like heart disease or active autoimmune disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups: one group will receive the new drug calderasib along with durvalumab, and the other group will receive a dummy treatment (placebo) along with durvalumab. Calderasib (or the placebo) is a tablet you take by mouth, and durvalumab is given as a drip into a vein. You would have regular hospital visits for check-ups, blood tests, scans, and to receive your treatment.

Doctors will closely monitor your health and how the treatment is working. The total duration of your participation, including the treatment and follow-up, could last for a few years. You will be told exactly what is involved before you agree to take part.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to receive a new medication that isn't yet widely available, which could potentially help your condition. However, there's no guarantee it will be effective for you, and it's also possible you could receive the dummy treatment. Like all medications, the study drugs can have side effects, which the medical team will discuss with you in detail. You will be closely monitored for any problems. It's very important to remember that joining a trial is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (98)

Duly Healthcare ( Site 0158)
Verified postcode
Lisle, United States· Recruiting
NHO Revive Research Institute LLC ( Site 0118)
Verified postcode
Lincoln, United States· Recruiting
New York Oncology Hematology P.C ( Site 9000)
Verified postcode
Albany, United States· Recruiting
WakeMed Raleigh Campus ( Site 0144)
Verified postcode
Raleigh, United States· Recruiting
Virginia Cancer Specialists ( Site 0114)
Verified postcode
Fairfax, United States· Recruiting
Instituto Alexander Fleming ( Site 0301)
Unverified
Ciudad Autonoma de Buenos Aires., Argentina· Recruiting
Hospital Italiano de Buenos Aires. ( Site 0300)
Unverified
Ciudad Autonoma de Buenos Aires, Argentina· Recruiting
Clinica Adventista Belgrano ( Site 0304)
Unverified
Ciudad Autonoma de Buenos Aires, Argentina· Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)
Verified postcode
Mar del Plata, Argentina· Recruiting
Hospital Britanico de Buenos Aires ( Site 0305)
Verified postcode
Buenos Aires, Argentina· Recruiting
Sanatorio Parque ( Site 0302)
Verified postcode
Rosario, Argentina· Recruiting
Northern Beaches Hospital ( Site 2401)
Verified postcode
Frenchs Forest, Australia· Recruiting

Common questions

What is 'locally advanced' lung cancer?

It means the cancer has grown in the lung or nearby areas, but hasn't spread to distant parts of the body, and it can't be removed by surgery.

What is a 'KRAS G12C' mutation?

It's a specific change in the genes of the cancer cells. Doctors can test for this to see if certain treatments might work better.

What is 'durvalumab'?

It's a type of immunotherapy that helps your body's own immune system fight the cancer cells.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real study drug but doesn't contain any active medicine. It's used to compare the effects of the actual drug.

Will I know if I'm getting the new drug or the placebo?

No, in this type of study (called 'blinded'), neither you nor your study doctor will know which treatment you are receiving until the study is over, or if there's a medical need to find out.

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.