Active not recruitingPHASE3INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer

This research study is for people with a type of advanced lung cancer called non-small cell lung cancer (NSCLC) that has a specific genetic change (KRAS G12C). If your cancer has come back or spread after previous treatments, you might be eligible. The main goal is to find out if a new medicine called divarasib is better and safer than two other approved medicines, sotorasib or adagrasib. All these medicines work by targeting the specific KRAS G12C change in the cancer cells. Participants would be closely monitored throughout the study to understand the effects of the treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

338

Start

23 Sep 2024

Estimated completion

30 Nov 2029

Non-Small Cell Lung Cancer KRAS G12C Lung Cancer

What is this study about?

This study is about a type of lung cancer called non-small cell lung cancer (NSCLC). In some people, this cancer has a specific change in its genes called a KRAS G12C mutation. This mutation can make the cancer grow and spread. If you've already had treatment for your advanced lung cancer and it's either come back or spread, this study might be relevant to you.

The study is comparing a new medication, called divarasib, with two medications that are already approved and widely used for this type of lung cancer in the UK – sotorasib and adagrasib. All these medications are designed to target and stop the growth of cancer cells that have the specific KRAS G12C genetic change. The researchers want to learn if divarasib is more effective at shrinking the cancer or stopping it from growing, and if it has fewer or different side effects compared to the other two drugs.

This is a 'Phase 3' study, which means it's one of the final steps before a new drug can be widely approved. Thousands of people worldwide are often involved in these studies. The information gathered will help doctors understand the best ways to treat this specific type of lung cancer in the future.

Key takeaways

This study is for advanced non-small cell lung cancer with a specific genetic change (KRAS G12C).
It compares a new drug, divarasib, to two existing treatments (sotorasib or adagrasib).
The aim is to find out if divarasib is safer and more effective.
Participation involves regular visits, tests, and taking study medication.
You might gain access to a new treatment, but there are potential risks and side effects.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to have advanced non-small cell lung cancer that your doctor has confirmed has the KRAS G12C genetic change. This means your cancer cannot be removed by surgery or treated with certain types of radiotherapy, and it has either spread or returned after you've had at least one other treatment for it. You should also generally be feeling well enough for daily activities.

There are several reasons you might not be able to join. For example, if you've already had a medicine that specifically targets the KRAS G12C change, or if you have certain other serious health problems like untreated brain cancer or uncontrolled fluid build-up around your lungs or heart. If you've had certain types of radiotherapy to your lung in the past six months, or if you have another type of lung cancer (like small cell lung cancer), you would also not be able to take part.

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 you have advanced non-small cell lung cancer that has spread or returned?
Has your doctor confirmed your cancer has the KRAS G12C genetic change?
Have you already had at least one other cancer treatment for your advanced cancer?
Are you generally feeling well enough to carry out daily activities?
Have you not previously taken a KRAS G12C-targeting drug or a similar broad RAS inhibitor?
Do you not have untreated cancer that has spread to your brain or spinal cord?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given one of the study medications (divarasib, sotorasib, or adagrasib). You won't know which one you'll be getting, nor will your doctors, which helps ensure the results are fair. You'll take the medication as prescribed by the study team. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment. These visits will help the doctors monitor your health and any side effects. The total duration of your participation will depend on how you respond to the treatment, but follow-up will continue even after you stop taking the study medication.

Potential risks and benefits

Taking part in this study could offer you access to a new medication (divarasib) before it's widely available, which might be more effective for your cancer. However, like all medications, the study drugs can have side effects, and some might be serious. There's no guarantee the treatment will work for you, and it might not improve your condition. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (151)

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

Banner Health MD Anderson AZ
Verified postcode
Gilbert, United States
Los Angeles Cancer Network
Verified postcode
Los Angeles, United States
UCLA Hematology / Oncology Clinic
Verified postcode
Los Angeles, United States
University of California, San Francisco
Verified postcode
San Francisco, United States
Yale Cancer Center
Verified postcode
New Haven, United States
University of Miami
Verified postcode
Miami, United States
Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)
Verified postcode
St. Petersburg, United States
University of Chicago Medical Center
Verified postcode
Chicago, United States
New England Cancer Specialists
Verified postcode
Westbrook, United States
Dana Farber Cancer Institute
Verified postcode
Boston, United States
University of Michigan
Verified postcode
Ann Arbor, United States
Cancer and Hematology Centers of Western Michigan
Verified postcode
Grand Rapids, United States

Common questions

What is KRAS G12C-positive lung cancer?

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

What does 'advanced or metastatic' mean?

It means the cancer has either spread beyond its original location or has returned after previous treatments.

Will I know which drug I'm receiving?

No, you, and your doctors, will not know whether you are receiving divarasib, sotorasib, or adagrasib. This is done to make sure the results are fair.

What are the common side effects of these types of drugs?

While specific side effects vary, drugs targeting KRAS G12C can commonly cause issues like diarrhoea, skin rashes, and changes in liver test results. Your doctor will discuss potential side effects in detail.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point without it affecting your future medical care.