Active not recruitingPHASE3INTERVENTIONAL

Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

This research study is looking into a new medication called MRTX849, also known as adagrasib. It's for people with a type of advanced lung cancer called non-small cell lung cancer that has a specific genetic change, or mutation, called KRAS G12C. The main goal is to see if MRTX849 works better or the same as a standard chemotherapy drug called docetaxel. Participants in this study will have already received other treatments for their lung cancer. By comparing these two treatments, doctors hope to find a more effective way to help patients with this particular type of lung cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Mirati Therapeutics Inc.

Enrolment target

453

Start

23 Feb 2021

Estimated completion

02 Jul 2026

Metastatic Non Small Cell Lung Cancer Advanced Non Small Cell Lung Cancer

Results

Results from this study

Posted January 2025

Results have been published for this study.

Primary outcome

Progression-Free Survival (PFS) as Per Blinded Independent Central Review

Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Full results on the registry

What is this study about?

This study is a Phase 3 clinical trial, which means it's a large and important step in testing a new medication. The medication being studied is called MRTX849, also known as adagrasib. It's designed for people who have advanced non-small cell lung cancer, which is the most common type of lung cancer. Specifically, this study focuses on lung cancer that has a particular genetic change called a KRAS G12C mutation. This mutation can make the cancer grow and spread.

In this study, MRTX849 is being compared to a chemotherapy drug called docetaxel. Docetaxel is a standard treatment for lung cancer that has spread or come back after initial treatments. The researchers want to find out if MRTX849 is more effective or has different benefits compared to docetaxel for patients who have already been treated for their metastatic lung cancer.

The reason this study is important is to find better treatment options for people living with this specific type of lung cancer. By comparing the new medication with a standard one, doctors can learn more about its effects, how well it works, and its side effects. This information helps medical professionals decide the best ways to treat future patients.

Key takeaways

Tests a new drug (MRTX849) for advanced lung cancer with a specific gene change (KRAS G12C).
Compares MRTX849 to a standard chemotherapy treatment (docetaxel).
For patients who have already received previous treatments for their lung cancer.
Aims to find out if MRTX849 is a better treatment option.
This is a large Phase 3 study, an important step in drug development.

Who may be eligible?

To join this study, you would need to have a confirmed diagnosis of non-small cell lung cancer that has spread, and tests must show that your cancer has the specific KRAS G12C gene mutation. You should also be considered well enough by your doctor to receive treatment with docetaxel, which is a standard chemotherapy.

There are also some reasons you might not be able to join. For example, if you have already received a different treatment that specifically targets the KRAS G12C mutation, you wouldn't be able to participate. Also, if your cancer has spread to your brain and is causing active problems, you would not be eligible.

For those who are in the study and receive docetaxel, if your cancer starts to grow again, you might be able to switch and receive MRTX849 instead. This is called a 'crossover.' However, if you've received any other cancer treatment between finishing docetaxel and trying to cross over, you wouldn't be able to.

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 that has spread?
Has my doctor confirmed my cancer has the KRAS G12C gene change?
Has my cancer been treated before, and has it progressed?
Am I considered well enough by my doctor to receive docetaxel chemotherapy?
Have I ever been treated with other drugs specifically for KRAS G12C mutations (like AMG 510 or Sotorasib)? (If yes, you might not be eligible)
Do I have active brain metastases (cancer spread to the brain that is causing symptoms)? (If yes, you might not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular visits to the clinic for check-ups, tests, and to receive your medication. These tests could include blood tests, scans (like CT scans) to see how the cancer is responding, and physical examinations. You would either receive MRTX849 or docetaxel as chosen by the study team, and you would take it for as long as your doctor and the study team think it's helping and you're not having too many side effects. The total length of your participation would depend on how your body responds to the treatment and other factors, but you would be monitored closely throughout.

Potential risks and benefits

Taking part in a study like this might offer the chance to receive a new, experimental treatment that may or may not work better than standard care. However, it's also important to remember that new treatments can have unexpected side effects, and some side effects could be serious. Standard treatments also have known side effects. There's no guarantee that the treatment will help your cancer. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (343)

Local Institution - 012-898
Verified postcode
Cerritos, United States
City of Hope - Duarte (Main Campus)
Verified postcode
Duarte, United States
Local Institution - 012-898 D
Verified postcode
Glendale, United States
Local Institution - 012-910-A
Verified postcode
Huntington Beach, United States
Local Institution - 012-910-C
Verified postcode
Irvine, United States
City Of Hope
Verified postcode
Long Beach, United States
Local Institution - 012-910-F
Verified postcode
Long Beach, United States
Local Institution - 012-910-D
Verified postcode
Newport Beach, United States
Local Institution - 012-898 C
Verified postcode
Santa Ana, United States
Providence Medical Group - Santa Rosa
Verified postcode
Santa Rosa, United States
Local Institution - 012-910-E
Verified postcode
Torrance, United States
Local Institution - 012-951-B
Verified postcode
Denver, United States

Common questions

What is a 'Phase 3' study?

Phase 3 studies are large trials comparing a new treatment with a standard one to see if it's better or safer, before it can be approved for wider use.

What is a KRAS G12C mutation?

It's a specific change in a gene (KRAS) found in some lung cancers, which can make the cancer grow. This study's new drug targets this specific change.

What does 'investigational agent' mean?

It means the drug, MRTX849, is still being tested and is not yet approved by health authorities for widespread use.

Why is docetaxel used in this study?

Docetaxel is a standard chemotherapy treatment for advanced lung cancer. It's used here to compare the new drug (MRTX849) against an existing option.

Can I choose which treatment I get?

No, in this type of study, you are usually assigned to receive either the new drug or the standard treatment, often randomly, so researchers can compare them fairly.