Olomorasib + Pembrolizumab for Non-Small Cell Lung Cancer

RM
Overseen ByRose M Hall
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with advanced non-small cell lung cancer (NSCLC) that cannot be cured. The combination includes olomorasib, a potential new drug, and pembrolizumab, an immunotherapy drug, to determine if they can extend the time patients live without cancer progression. The study also evaluates the treatment's effectiveness in shrinking tumors and monitors any side effects. Participants with a specific gene mutation (KRAS G12C) and a protein score (PD-L1 between 1% and 49%) may be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment combination is likely to be safe for humans?

Earlier studies have shown that the combination of olomorasib and pembrolizumab is safe for patients with advanced non-small cell lung cancer (NSCLC) who have a specific genetic change called KRAS G12C. Research suggests that patients generally tolerate this treatment well. Those who tried it reported manageable side effects. While some side effects occurred, they were not severe for most patients. The FDA has granted this combination a Breakthrough Therapy Designation, indicating its promise in treating this type of cancer.12345

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

Researchers are excited about the combination of Olomorasib and Pembrolizumab for treating non-small cell lung cancer (NSCLC) because it targets a specific mutation known as KRAS G12C. This is significant because most current treatments don't specifically address this mutation, which is found in a subset of NSCLC patients. Olomorasib works by directly inhibiting the KRAS G12C mutation, while Pembrolizumab is an immunotherapy that helps the body's immune system attack cancer cells. By combining these two mechanisms, the treatment offers a promising new approach that could potentially improve outcomes for patients who have limited options with existing therapies.

What evidence suggests that this treatment might be an effective treatment for non-small cell lung cancer?

Research has shown that combining olomorasib with pembrolizumab may effectively treat advanced non-small cell lung cancer (NSCLC) with a specific KRAS G12C mutation. In this trial, participants with locally advanced or metastatic NSCLC will receive this combination. Studies have found that up to 77% of patients experienced tumor shrinkage with this treatment. This combination is noted for its strong tumor-fighting ability and generally manageable safety profile. These findings suggest that this treatment could help slow cancer progression and improve patient outcomes.12345

Who Is on the Research Team?

SA

Shetal A Patel, MD, PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation and a PD-L1 score between 1% and 49%. It is intended for people who have not received prior treatment for their advanced cancer.

Inclusion Criteria

I am 18 years old or older.
I have advanced NSCLC that has not been treated and cannot be cured with surgery or radiation.
My cancer has a KRAS G12C mutation confirmed by a certified lab test.
See 5 more

Exclusion Criteria

I have uncontrolled fluid buildup around my heart or lungs due to my disease.
Subject has a serious pre-existing medical condition(s) that, in the judgment of the Investigator, would preclude participation in this study, including interstitial lung disease (ILD) or severe dyspnea at rest

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olomorasib and pembrolizumab as first-line treatment for advanced or metastatic NSCLC

Up to 2 years
Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety, effectiveness, and progression-free survival after treatment

Up to 5 years
Periodic visits for assessment

What Are the Treatments Tested in This Trial?

Interventions

  • Olomorasib
  • Pembrolizumab

Trial Overview

The study tests the combination of two drugs, olomorasib and pembrolizumab, as an initial treatment. Researchers want to see if this combo helps patients live longer without their cancer getting worse compared to typical outcomes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: locally advanced or metastatic NSCLC receive olomorasib and pembrolizumabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41319864/

Efficacy and Safety of Olomorasib in Combination With ...

Conclusion: Olomorasib plus pembrolizumab demonstrated manageable safety and promising antitumor activity in patients with KRAS G12C-mutant ...

Efficacy and Safety of Olomorasib in Combination With ...

Olomorasib plus pembrolizumab demonstrated manageable safety and promising antitumor activity in patients with KRAS G12C-mutant advanced NSCLC across PD-L1 ...

Promising Trial Data Leads to Breakthrough Designation ...

Olomorasib, combined with Keytruda, targets KRAS G12C-mutant NSCLC, showing high efficacy in trials with significant objective response and ...

Olomorasib, Keytruda Combo Is Safe for Lung Cancer Subset

Olomorasib plus Keytruda was proven to be safe and well tolerated for patients with KRAS G12C-mutant non-small cell lung cancer.

Efficacy and Safety of Olomorasib in Combination With ...

Olomorasib demonstrated the ability to be combined with pembrolizumab with a manageable safety profile and promising efficacy, with an overall ORR of 57% ...