Adagrasib for KRAS-Mutated Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
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 Adagrasib safe for humans?
What makes the drug Adagrasib unique for treating KRAS-mutated lung cancer?
Adagrasib is unique because it is an oral drug that specifically targets the KRAS G12C mutation, which is common in non-small cell lung cancer and has been difficult to treat. It works by binding to the mutant protein and keeping it inactive, which helps stop cancer growth without affecting normal proteins.13456
What data supports the effectiveness of the drug Adagrasib for KRAS-mutated lung cancer?
Adagrasib has shown considerable effectiveness in treating non-small cell lung cancer with the KRAS G12C mutation, with studies reporting good response rates. It was approved in the USA based on its ability to shrink tumors and maintain this effect, and it is generally well tolerated by patients.13457
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:
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