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RecruitingPHASE3INTERVENTIONAL

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

This research study is investigating a new medication called olomorasib (LY3537982) when given alongside pembrolizumab and/or chemotherapy. It's for people with advanced non-small cell lung cancer (a common type of lung cancer) that has a particular genetic fault known as KRAS G12C. This study specifically targets individuals who have not received prior treatment for their advanced lung cancer that has spread. The main goal is to determine if adding olomorasib to existing treatments is more effective at controlling the cancer compared to the standard treatments alone. Participation could last up to three years, depending on individual health and how the cancer responds.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
1,264
Start
21 Dec 2023
Estimated completion
01 Jan 2031

What is this study about?

This study is about finding better ways to treat a type of lung cancer called non-small cell lung cancer that has spread to other parts of the body (advanced disease). Researchers are looking at a new drug called olomorasib (also known as LY3537982). This drug is being tested alongside other standard cancer treatments, like pembrolizumab and chemotherapy.

The important thing about this study is that it's for people whose lung cancer has a specific change, called a KRAS G12C mutation. This means there's a particular error in their cancer cells' genetic code. Knowing about this specific change helps doctors choose treatments that might work best for that type of cancer. The study wants to see if this new combination of drugs works better than the usual treatments for people starting their first treatment for their advanced lung cancer with this KRAS G12C mutation.

By joining this study, you would be helping doctors understand if this new treatment can improve outcomes for people with this specific type of lung cancer. The study aims to make sure that any new treatments are safe and effective. Your participation could potentially help others in the future, even if it doesn't directly help you in the way you hope. No medical recommendations are made, this is an explanation of the trial.

Key takeaways

  • Targets advanced non-small cell lung cancer with a specific KRAS G12C genetic change.
  • Compares a new drug (olomorasib) with standard treatments like pembrolizumab and chemotherapy.
  • For patients who haven’t had previous treatment for their advanced lung cancer.
  • Aims to see if the new combination is more effective.
  • Participation involves regular check-ups and monitoring for up to 3 years.
  • You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would need to have non-small cell lung cancer that has spread and cannot be cured by surgery or radiation. Your cancer must also have a specific genetic change called KRAS G12C. This study is for people who haven't had other treatments for their advanced lung cancer already, although in some urgent cases, one cycle of initial treatment might be allowed.

Important factors include being generally well enough to participate, with a good estimated life expectancy of at least 12 weeks, and the ability to swallow capsules. Your doctor will check your overall health and various blood tests to make sure you can safely take part. For women who could become pregnant, a negative pregnancy test is needed, and you must not be breastfeeding during the study.

You would not be able to join if your cancer has other specific genetic changes that doctors already know how to treat, such as EGFR or ALK mutations. Also, if you have active cancer in your brain or the lining around your brain, you wouldn't be able to participate. This study is generally for people aged 18 and over, of any sex.

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.

  1. Do you have non-small cell lung cancer that has spread?
  2. Has your doctor confirmed your cancer has the KRAS G12C genetic change?
  3. Have you not received other treatments for your advanced lung cancer yet?
  4. Are you generally well enough to take part and can swallow capsules?
  5. Do you not have active cancer in your brain or the lining around your brain?
  6. Are you over 18 years old?
Answer every question to see your result.

What does participation involve?

If you decide to participate, the study could last up to three years. This isn't a fixed time, but rather depends on how you are feeling and how your lung cancer is responding to treatment. You would receive one of the study drugs – olomorasib, pembrolizumab, or a placebo (a dummy pill) – possibly along with chemotherapy, according to a plan decided by the study doctors.

Throughout the study, you would have regular visits to the clinic for medical checks, blood tests, and scans. These assessments help the doctors monitor your health, how the treatment is working, and if you are experiencing any side effects. You can always decide to stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new medications that aren't yet widely available, and helping advance medical knowledge for future patients. However, there are also potential risks involved. The new drugs might cause side effects, some of which could be serious, or they may not be more effective than standard treatments. Your care team will closely monitor you for any problems. It's very important to remember that you have the right to withdraw from the study at any time without having to give a reason, and this will not affect your ongoing medical care or relationship with your healthcare team.

Locations (422)

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
  • Banner MD Anderson Cancer Center
    Verified postcode
    Gilbert, United States· Recruiting
  • Banner University Medical Center Phoenix
    Verified postcode
    Phoenix, United States· Recruiting
  • The University of Arizona Cancer Center - North Campus
    Verified postcode
    Tucson, United States· Recruiting
  • Highlands Oncology Group
    Verified postcode
    Springdale, United States· Recruiting
  • Cedars-Sinai Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Mercy Cancer Center
    Verified postcode
    Merced, United States· Recruiting
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    Verified postcode
    Torrance, United States· Completed
  • BASS Cancer Center
    Verified postcode
    Walnut Creek, United States· Recruiting
  • USO - Rocky Mountain Cancer Centers
    Verified postcode
    Lone Tree, United States· Recruiting
  • Yale University School of Medicine
    Verified postcode
    New Haven, United States· Recruiting
  • Sibley Memorial Hospital
    Verified postcode
    Washington D.C., United States· Recruiting

Common questions

What is KRAS G12C-mutant non-small cell lung cancer?

It's a common type of lung cancer where the cancer cells have a specific change in a gene called KRAS. This change is called 'G12C'.

What is olomorasib (LY3537982)?

It's a new medication being tested in this study. It aims to target the specific KRAS G12C change in cancer cells.

Will I definitely receive the new drug?

Not necessarily. This study involves different treatment groups, and you might receive the new drug, standard treatment, or a placebo, depending on which group you are assigned to.

How long will I be in the study?

Participation could last up to three years, but the exact duration depends on your health and how your cancer responds.

Can I leave the study if I change my mind?

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

How to find out more

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

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of First-Line Olomorasib (LY3537982) and Pembrolizum…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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