AMG 510-GLAS (Lung Cancer)
What is the Purpose of this Study?
The study is divided into 3 parts: screening, the study drug period, and follow-up.
If you choose to join the study, you will go through a screening period that lasts up to 28 days. During this period, you will:
- Have physical exams
- Answer questionnaires
- Have blood draws
- Have other tests that your study doctor determines to be necessary
If you are eligible to continue on to the study drug period, you will:
- Be randomly assigned (like a coin flip) to take a 960mg or 240mg dose of the study drug
- Take the study drug by mouth once daily for drug cycles that last 21 days each
- Visit our clinic every 3 weeks for tests and assessments at the end of each drug cycle
The number of drug cycles you do in the study will depend on how your cancer responds to the study drug.
The follow-up period begins when you stop taking the study drug. During this period, you will
- Visit our clinic for a check-up about a month after your last dose of the study drug
- Visit our clinic or talk with us over the phone every 12 weeks after the first visit to let us know how you are doing
The follow-up period will last for up to 5 years.
If you choose to join the study, you will go through a screening period that lasts up to 28 days. During this period, you will:
- Have physical exams
- Answer questionnaires
- Have blood draws
- Have other tests that your study doctor determines to be necessary
If you are eligible to continue on to the study drug period, you will:
- Be randomly assigned (like a coin flip) to take a 960mg or 240mg dose of the study drug
- Take the study drug by mouth once daily for drug cycles that last 21 days each
- Visit our clinic every 3 weeks for tests and assessments at the end of each drug cycle
The number of drug cycles you do in the study will depend on how your cancer responds to the study drug.
The follow-up period begins when you stop taking the study drug. During this period, you will
- Visit our clinic for a check-up about a month after your last dose of the study drug
- Visit our clinic or talk with us over the phone every 12 weeks after the first visit to let us know how you are doing
The follow-up period will last for up to 5 years.
What is the Condition Being Studied?
Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation
Who Can Participate in this Study?
Adults ages 18+ who:
- Are diagnosed with stage 4 NSCLC with KRAS G12C mutation
- Have not started treatment for their cancer yet
For more information about who can participate in this study, please contact the study team at 919-681-4768.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to find out how well a drug called sotorasib (the study drug) works as a first-line treatmetn for people with stage 4 NSCLC whose tumors have a KRAS G12C mutation.
Study Details
Full Title
Amgen Protocol 20190288: A Phase 2, Multicenter, Single Arm, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC Whose Tumors Harbor a KRAS G12c Mutation in Need of First-line Treatment (CodeBreaK 201)
Principal Investigator
Protocol Number
IRB:
PRO00108582
NCT:
NCT04933695
ClinicalTrials.gov
View on ClinicalTrials.gov