Will I know which drug I’m taking?
Yes, you will know, which study drug you are taking, because this is an open-label study. This study is also randomized, which means that you will not know in advance to which study arm you will be assigned, in the standard of care arm with pembrolizumab alone, or in the combination of pembrolizumab and adagrasib.
- “Open label” means that you and your study doctor will know which study drugs you’re getting
- “Randomized” means that you will be placed randomly, like a flip of a coin or a 50/50 chance, in an “arm” or group
Study period details
Prescreening period:
The study doctor will conduct tests to see if your tumor is positive for the KRASG12C mutation and to determine the level of PD-L1 present.
Screening period:
The study doctor will then conduct a series of tests and assessments to evaluate if you meet the specific criteria for participation in the study. Eligible patients will then be enrolled in the study if they agree to participate and sign an informed consent form. If any of the tests show that you are not the right fit to be part of the study, your study doctor will explain to you why you are not eligible and will discuss other treatment options with you.
Treatment period:
Standard-of-care (SOC) treatment is one that is accepted and widely used by healthcare professionals and, in this trial, consists of pembrolizumab. The trial will look at an investigational study drug called adagrasib, which will be used together with SOC in comparison with SOC (pembrolizumab) alone.
- Pembrolizumab is given as an IV infusion (through a tiny tube in your vein) every 3 weeks and adagrasib is given as an tablet to be taken 2 times per day, every day.
- Patients in the investigational arm will receive adagrasib continuously until disease progression, unacceptable adverse events, receipt of the maximal number of cycles per local standard of care, investigator decision or their own refusal
- Pembrolizumab will be administered for approximately 2 years, or in accordance with approved local labeling until it is considered by your study doctor and discussed with you that you are not benefiting from this treatment anymore. A different treatment option will be discussed with you.
- Patients who are still benefiting from the investigational study treatment as determined by the doctor, may continue with the investigational study treatment even if their disease progresses.
Follow-up period, end of treatment (EoT), initial follow-up, long-term follow-up:
You will stop the study drugs but continue to meet with your study team to follow your disease status and any side effects.
- The EoT visit occurs 28-35 days after the last dose of investigational study treatment.
- If your disease does not respond well to the investigational study treatment or the study treatment stops working, your doctor will talk to you about other treatment options.
- You will also have a health check-in (phone call and/or email) every 3 months from the EoT visit.
