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Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients

Researchers are conducting a study for people with a specific type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that has a particular genetic mutation, known as KRAS G12C. This study is testing new drug combinations: avutometinib with sotorasib, and sometimes also with defactinib. The main goal is to find out if these combinations are safe and if they can help shrink the cancer or stop it from growing. It is open to patients who have or haven't been treated with a similar drug called a G12C inhibitor before. This is an important step in finding better ways to treat this specific type of lung cancer.

At a glance

Status
Active not recruiting
Phase
PHASE1, PHASE2
Sponsor
Verastem, Inc.
Enrolment target
153
Start
12 Apr 2022
Estimated completion
01 Apr 2027

What is this study about?

This study is focused on a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC), specifically for people whose cancer has a particular genetic change known as a KRAS G12C mutation. This mutation needs specific treatments, and doctors are always looking for more effective options.

In this study, researchers are exploring combinations of existing and new drugs. They are particularly interested in a drug called avutometinib, which they are testing alongside sotorasib, and sometimes with a third drug called defactinib. The main aim is to understand how safe these drug combinations are and to see if they can effectively fight the cancer. This includes looking at whether the cancer shrinks or stops growing. Researchers are studying patients who have previously received a 'KRAS G12C inhibitor' drug, as well as those who haven't, to see how the new combinations work in different situations.

The information gathered from this study will be crucial for developing better treatments for people with this specific type of lung cancer. By carefully testing these drug combinations, researchers hope to find new ways to improve patient outcomes and quality of life.

Key takeaways

  • This study is for a specific type of lung cancer (NSCLC with KRAS G12C mutation).
  • It's testing new drug combinations to see if they are safe and effective.
  • Participation involves taking oral medications and regular hospital visits.
  • You will be closely monitored for side effects and how your cancer responds.
  • It's an 'open-label' study, meaning you'll know which drugs you're taking.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have a confirmed diagnosis of Non-Small Cell Lung Cancer with the specific KRAS G12C genetic change. Your cancer also needs to be measurable on scans. You should generally be well enough to carry out most daily activities without much difficulty, which doctors call an ECOG performance status of 0 or 1. You must also have sufficient organ function (like your liver and kidneys) and have recovered from side effects of any previous treatments.

There are also some reasons why you might not be able to join. For example, if you've had certain other cancers recently, received anti-cancer treatment in the last four weeks, or had major surgery recently. You wouldn't be eligible if you have certain active infections (like Hepatitis B or C, or HIV), significant heart or lung conditions, uncontrolled brain spread from your cancer, or if you can't swallow tablets. Women who are pregnant or breastfeeding cannot participate.

To ensure your safety, there are also checks to make sure you haven't recently used certain medications or have specific skin conditions. The medical team will review all your information carefully to determine if this study is suitable for you.

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. Are you 18 years or older?
  2. Do you have Non-Small Cell Lung Cancer with a confirmed KRAS G12C mutation?
  3. Is your cancer measurable on scans?
  4. Are you generally well enough for most daily activities?
  5. Are you able to swallow tablets or capsules?
  6. Are you NOT pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be taking medications by mouth (tablets or capsules). The exact number of visits and tests will vary, but typically involves regular hospital appointments for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You'll be closely watched for any side effects. You'll also need to commit to using effective contraception throughout the study if you are able to have children. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but there will be ongoing follow-up to monitor your progress and health.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as access to new treatments before they are widely available, which might improve your cancer or quality of life. However, there are also potential risks, as the drugs may cause side effects, some of which could be serious. The medical team will explain all known side effects and monitor you closely for any new ones. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (35)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Rocky Mountain Cancer Center, LLP
    Verified postcode
    Boulder, United States
  • Georgetown University Medical Center
    Verified postcode
    Washington D.C., United States
  • MedStar Washington Hospital Center, MedStar Georgetown Cancer Institute,
    Verified postcode
    Washington D.C., United States
  • Illinois Cancer Specialists
    Verified postcode
    Arlington Heights, United States
  • Maryland Oncology & Hematology, P.A.
    Verified postcode
    Rockville, United States
  • Dana Farber Cancer Institute
    Verified postcode
    Boston, United States
  • Henry Ford Health System
    Verified postcode
    Detroit, United States
  • Minnesota Oncology Hematology, P.A
    Verified postcode
    Woodbury, United States
  • Washington University School of Medicine
    Verified postcode
    St Louis, United States
  • Cleveland Clinic Taussig Cancer Center
    Verified postcode
    Cleveland, United States
  • Ohio State University Brain and Spine Hospital
    Verified postcode
    Columbus, United States
  • Consultants in Medical Oncology & Hematology
    Verified postcode
    Broomall, United States

Common questions

What is Non-Small Cell Lung Cancer (NSCLC)?

It's the most common type of lung cancer, and this study focuses on a specific form of it with a particular gene change.

What does 'KRAS G12C mutation' mean?

It's a specific genetic change found in some cancer cells that doctors look for because it can affect which treatments might work best.

Are the drugs in this study new?

Some of the drugs might be new or are being tested in new combinations to see if they work better together.

Will I know which treatment I'm getting?

Yes, in this type of study, both you and your doctors will know which specific drug combination you are receiving.

What if I feel unwell during the study?

Your health will be closely monitored by the study team, and you should always inform them about any new or worsening symptoms immediately.

How to find out more

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

Discussion

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