RecruitingPHASE3INTERVENTIONAL

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

This research study is looking into a new medication called olomorasib for a specific type of lung cancer known as non-small cell lung cancer (NSCLC). This particular cancer must have a genetic change called KRAS G12C. The study is split into two main parts. For people with lung cancer that has been removed by surgery (resected), we're comparing olomorasib combined with pembrolizumab against pembrolizumab and a dummy drug (placebo). For those whose lung cancer cannot be removed by surgery (unresectable), we're comparing olomorasib with durvalumab against durvalumab and a placebo. The main aim is to find out if adding olomorasib makes the current treatments more effective. Your involvement in the study could last up to three years.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

700

Start

27 Mar 2025

Estimated completion

01 Feb 2032

Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is all about finding better ways to treat a specific kind of lung cancer called non-small cell lung cancer (NSCLC) that has a genetic change known as KRAS G12C. This genetic change makes the cancer grow in a particular way. Doctors are always looking for new treatments, and in this study, they're focusing on a new drug called olomorasib.

The study wants to see if olomorasib, when given alongside existing treatments, works better than the existing treatments alone. To do this, the study is divided into two groups. One group is for people whose lung cancer has been removed by surgery. They will receive either olomorasib plus pembrolizumab, or pembrolizumab plus a dummy drug (placebo). The other group is for people whose lung cancer cannot be removed by surgery. They will receive either olomorasib plus durvalumab, or durvalumab plus a placebo. A placebo looks just like the real drug but has no active medicine. This helps researchers fairly compare how well the new drug works.

By taking part, you would be helping doctors understand if olomorasib can improve treatment for this specific type of lung cancer. This kind of research is really important for developing new and more effective medicines for future patients, offering hope for better outcomes.

Key takeaways

This study tests a new drug, olomorasib, for a specific type of lung cancer (KRAS G12C-mutant NSCLC).
It aims to see if olomorasib improves current standard treatments.
The study involves both people whose cancer has been removed and those whose cancer cannot be removed.
Participation could last up to three years with regular check-ups.
You might receive the new drug or a dummy drug (placebo).
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must have been diagnosed with non-small cell lung cancer (NSCLC) and a specific genetic change called KRAS G12C. Your doctors must know your PD-L1 expression level. You should generally be feeling well and able to carry out your daily activities with little difficulty, and be able to swallow tablets or capsules. Good results from routine blood tests are also needed.

For those who have had surgery, this study is for specific stages of NSCLC where some tumour was still present after initial treatment, or for certain stages when surgery was the first treatment. For those whose cancer cannot be removed by surgery, you must have advanced NSCLC and show no signs of your cancer getting worse during your current chemotherapy and radiotherapy treatment.

You cannot join the study if you have other specific genetic changes in your cancer (like EGFR or ALK), or if you've had another cancer that needed treatment recently. Also, if you have certain serious autoimmune diseases or have experienced severe side effects from previous immunotherapy, this study might not be suitable for you. Women who could become pregnant will need a negative pregnancy test and must not be breastfeeding.

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 with a KRAS G12C gene change?
Am I generally feeling well and active (ECOG 0 or 1)?
Can I swallow tablets or capsules easily?
Have I either had surgery for my lung cancer (certain stages) or is my advanced lung cancer not getting worse during my current treatment?
Do I have good results from my routine blood tests?
Have I *not* had serious autoimmune diseases or severe past reactions to immunotherapy?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study medication (either olomorasib or a placebo) along with your standard treatment (pembrolizumab or durvalumab). You would have regular visits to the clinic for check-ups, blood tests, and scans to see how you're responding to treatment and to monitor for any side effects. These visits will help the medical team keep a close eye on your health and the progress of your cancer. Your involvement in the study could last for up to three years, depending on your individual response and how well you tolerate the treatment. During this time, you would be asked to follow specific instructions regarding your medication and report any new symptoms or changes in your health.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as gaining access to a new treatment (olomorasib) that is not yet widely available and receiving close medical monitoring. However, there are also potential risks involved. The study drug or combinations might cause side effects, some of which could be serious or unexpected. These will be explained to you fully before you decide to join. You will be given detailed information about all known risks. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (361)

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

Clearview Cancer Institute
Verified postcode
Huntsville, United States· Recruiting
Infirmary Cancer Care
Verified postcode
Mobile, United States· Suspended
City of Hope, Phoenix
Verified postcode
Phoenix, United States· Not yet recruiting
The University of Arizona Cancer Center - North Campus
Verified postcode
Tucson, United States· Recruiting
Highlands Oncology Group
Verified postcode
Springdale, United States· Recruiting
UCLA Hematology/Oncology - Santa Monica
Verified postcode
Los Angeles, United States· Not yet recruiting
Profound Research LLC
Verified postcode
Oceanside, United States· Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Verified postcode
Orange, United States· Not yet recruiting
Stanford Cancer Center
Verified postcode
Palo Alto, United States· Recruiting
Kaiser Permanente San Diego Mission Road
Verified postcode
San Diego, United States· Recruiting
BASS Cancer Center
Verified postcode
Walnut Creek, United States· Recruiting
Hartford Hospital (HH)
Verified postcode
Hartford, United States· Recruiting

Common questions

What is KRAS G12C-mutant NSCLC?

It's a specific type of lung cancer where the cancer cells have a particular genetic change called KRAS G12C, which helps the cancer grow.

What is a placebo?

A placebo is a dummy drug that looks just like the real medication but doesn't contain any active medicine. It helps researchers compare the new drug fairly.

How long will I be in the study?

Your involvement in the study could last for up to three years, depending on your health and how you respond to the treatment.

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 doctors will know whether you are receiving the new drug or the placebo. This helps ensure fair results.

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

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

lillytrials@lilly.com 1-317-615-4559 Official trial record

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