New study evaluates a medication for NSCLC with the KRAS G12C mutation

What treatment options are available to people with nonsquamous non-small cell lung cancer when their cancer does not respond well to current immunotherapy or continues to progress?

That's what a clinical trial enrolling patients at Providence Cancer Institute aims to answer.

The phase Ib/II, two-part study, known as KEYMAKER-U01, will evaluate investigational medications in people with nonsquamous non-small cell lung cancer (NSCLC) that has already been treated after spreading to other parts of the body, and whose cancers carry the KRAS G12C mutation. Rachel Sanborn, M.D., is the principal investigator at Providence.

Why this trial is important

At diagnosis, about 70% of people with NSCLC already have advanced cancer that cannot be removed with surgery. While some people with early-stage NSCLC have surgery, for many, the cancer comes back in other parts of the body. These challenges help explain why the 5-year relative survival is 32% for people diagnosed with NSCLC overall and 12% for those with advanced or metastatic disease.

Although recent studies show that progress has been made, many people with advanced NSCLC still need better treatment options, especially if their cancer does not respond to current treatments or starts growing again.

Considering investigational medications

For this clinical trial, researchers are studying the investigational medication, MK-1084, in new treatment combinations that may improve response rates, slow cancer growth and help people live longer.

MK-1084 is a selective inhibitor of the KRAS G12C mutation that is taken as an oral tablet. In this study, the goals are to learn about the safety of MK-1084, if people tolerate it when taken with other treatments, and how many people enrolled in the study respond to the treatments.

MK-1084 that will be evaluated in combination with:

• Patritumab deruxtecan (Experimental medication)
• Sacituzumab tirumotecan: (Experimental medication)

How the trial works

KEYMAKER-U01 is designed in two parts:

• Part 1 will test different doses of the trial drug combinations - MK-1084 paired with either patritumab deruxtecan or sacituzumab tirumotecan - to identify a recommended dose.
• Part 2 will begin only after those doses are established. In this part, participants will be randomly assigned to one of two treatment groups: MK-1084 with patritumab deruxtecan or MK-1084 with sacituzumab tirumotecan. Each participant has an equal chance of being placed in any of the three groups.

This is not a blind study; in both parts of the trial, participants, their doctor and clinical trial team will know which medications are being given.

Find out more about the study

A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

Providence Cancer Institute is currently enrolling patients in this study.

• Call 503-215-1979
• Send an email

Find out about other clinical trials at Providence Cancer Institute.

Related news

Dark genome, bright outcome: A first-of-its-kind trial gives Del Abbott a second chance

A new liver cancer trial explores a "two-in-one" treatment approach

Providence Cancer Institute secures three significant grants