Olomorasib + Pembrolizumab for Non-Small Cell Lung Cancer
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olomorasib and pembrolizumab as first-line treatment for advanced or metastatic NSCLC
Follow-up
Participants are monitored for safety, effectiveness, and progression-free survival after treatment
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
Locally advanced or metastatic non small cell lung cancer (NSCLC) patients with KRAS G12C+mutant, PD-L1 TPS 1-49% receive lolomorasib and pembrolizumab.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Citations
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 ...
3.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/promising-trial-data-leads-breakthrough-designation-eli-lilly-investigational-kras-g12c-inhibitor-advanced-metastatic-non-small-cell-lung-cancerPromising 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% ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.