Adagrasib for KRAS-Mutated Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called adagrasib (also known as Krazati or MRTX-849) for individuals with a specific type of lung cancer that has a KRAS G12C mutation. Researchers aim to evaluate the effectiveness of two different doses for treating this cancer. The trial seeks participants whose cancer has spread and who have already undergone chemotherapy and immune checkpoint inhibitors. It is not suitable for those who have previously received a KRAS G12C targeted treatment or have certain untreated brain conditions. Participants must have recovered from their previous cancer treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you have certain medical conditions or need to take certain medications that could make it unsafe, a trial doctor might advise changes.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that adagrasib is generally safe for people with KRAS-mutated non-small-cell lung cancer (NSCLC). In earlier studies, patients who took adagrasib did not experience unexpected or dangerous side effects.
Studies have found that adagrasib is well-tolerated, with most side effects being mild and manageable. This is important because it allows most people to continue treatment without serious problems.
Adagrasib has been used in patients before and demonstrated benefits without causing new safety issues. This supports the idea that the treatment is safe for people with this specific type of lung cancer.
Overall, current evidence suggests that adagrasib is a safe option for those considering joining a clinical trial for KRAS-mutated lung cancer.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Adagrasib for KRAS-mutated lung cancer because it targets a specific mutation in the KRAS gene, which is a common driver of cancer cell growth. Unlike standard treatments like chemotherapy, which attack rapidly dividing cells in general, Adagrasib specifically inhibits the KRAS G12C mutation, potentially leading to more effective and targeted therapy with fewer side effects. Additionally, Adagrasib is available in two formulations: one taken without regard to food at 600mg twice daily, and another taken with food at 400mg twice daily, offering flexibility in dosing that can improve patient convenience and adherence.
What evidence suggests that adagrasib might be an effective treatment for KRAS-mutated lung cancer?
In previous studies, adagrasib has shown promising results for treating KRAS G12C-mutated non-small cell lung cancer (NSCLC). Research indicates that patients taking adagrasib experienced longer periods without cancer progression, known as improved progression-free survival. One study showed that adagrasib delayed cancer progression more effectively than the usual treatment, docetaxel. This trial will test different dosages of adagrasib, specifically 600mg BID and 400mg BID. Additionally, another study found that combining adagrasib with pembrolizumab, a drug that boosts the immune system, further improved survival rates. These findings suggest that adagrasib could be a strong option for people with this specific type of lung cancer.14678
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic NSCLC who have the KRAS G12C mutation and previously underwent chemotherapy including cisplatin or carboplatin, plus immune checkpoint inhibitors. They should be recovered from prior treatments with safe blood test levels. Those ineligible include patients who could undergo surgery to remove cancer, those treated before with KRAS G12C targeting drugs, individuals with certain medical conditions or on conflicting medications, pregnant women, and patients with specific brain lesions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adagrasib monotherapy with two dosing regimens (600 mg BID without regard to food versus 400 mg BID with food)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including patient-reported outcomes and quality of life assessments
Long-term Follow-up
Evaluate overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Adagrasib
Adagrasib is already approved in United States, European Union for the following indications:
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
- KRAS G12C-mutated locally advanced or metastatic colorectal cancer
- KRAS G12C mutation non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mirati Therapeutics Inc.
Lead Sponsor
Dr. Charles M. Baum
Mirati Therapeutics Inc.
Chief Executive Officer since 2023
MD, PhD
Dr. Joseph Leveque
Mirati Therapeutics Inc.
Chief Medical Officer since 2021
MD