Summary:
Why is the RMC-4630 study being done?
The purpose of this study is to test a new drug called RMC-4630 in combination with Sotorasib. RMC-4630 is a new investigational (experimental) drug, which means that it is not yet approved by the US Food and Drug Administration (FDA) or any other health authorities. Sotorasib (LUMAKRAS™) has been approved by the FDA for participants with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). This study will test the safety and anti-tumor effects of RMC-4630 and Sotorasib when given together in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
What happens during the study?
There are 3 study periods: screening, treatment, and follow-up. All aspects of your participation will take place at the study location or at your place of residence.
Screening:
- You will have health checks and tests to confirm that you are eligible for the study.
- You will be given an Informed Consent Form that contains all of the information about the study. This is to make sure that you understand the study and ask any questions you may have. If you agree to participate, you will give your permission by signing this form.
- The screening period is up to 28-days before the first dose of the study drug.
Treatment:
- During the treatment period, eligible patients will receive the combination of RMC-4630 and Sotorasib in 21-day cycles. The treatment period will continue until unacceptable adverse events, documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study (whichever occurs first).
- The study medication will be taken.
Follow-Up:
- Subjects will be followed via telephone every 3 months for assessment of survival and documentation of anticancer treatment.
Qualified Participants May Receive:
What treatment will I receive?
You will receive both RMC-4630 and Sotorasib.
- RMC-4630 will be administered on days 1 and 2 of each week in a 21-day cycle
- Sotorasib will be administered daily
What tests will I have?
During the study, you may have tests to assess:
- Blood
- Heart Activity
- Urine
- Medical Imaging
Will I receive compensation for participating in this study?
Yes, you will receive $333 upon your completion of the screening visit and $183 for each subsequent clinical visit. Additionally, you will be compensated for $50 for each follow-up call that occurs every 3 months until your withdrawal or termination from the study.