Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
This research study is looking at a new medicine called zoldonrasib, given alongside standard chemotherapy, for people in the UK who have pancreatic cancer that has spread to other parts of the body. This specific type of pancreatic cancer has a particular gene change called 'KRAS G12D mutation'. Participants will be randomly put into one of two groups: one group gets zoldonrasib plus chemotherapy, and the other gets a dummy pill (placebo) plus chemotherapy. The main goal is to find out if adding zoldonrasib helps people live longer or stops their cancer from growing for a longer time, compared to chemotherapy alone. This is a Phase 3 study, which means it's a large trial testing if the new treatment is better than existing ones.
At a glance
What is this study about?
Pancreatic cancer can be a challenging disease, especially when it has spread to other parts of the body. Doctors and scientists are always looking for new and better ways to treat it. This particular study is testing a new drug called zoldonrasib. This drug is designed to target a specific change in cancer cells, known as the 'KRAS G12D mutation'. This mutation is like a tiny switch that helps the cancer grow, and zoldonrasib aims to turn that switch off.
In this study, zoldonrasib is being given alongside chemotherapy, which is a standard treatment for pancreatic cancer. We want to see if this new combination works better than chemotherapy alone. 'Better' in this case means if it helps people live longer or stops the cancer from growing for a longer period of time. This is a common way to measure how effective a new cancer treatment is.
This is a 'Phase 3' study, which means it's a large and important trial. It's comparing the new treatment combination to the current standard treatment (chemotherapy with a dummy pill) to confirm if the new approach is indeed more effective and safe. By taking part, patients could help researchers learn valuable information that might lead to new treatment options for others in the future.
Key takeaways
- This study is for people with pancreatic cancer that has spread, and has a specific gene change (KRAS G12D).
- It tests a new drug called zoldonrasib alongside standard chemotherapy.
- You'll be randomly assigned to get either the new drug or a dummy pill, both with chemotherapy.
- The main goal is to see if the new treatment helps people live longer or slows cancer growth.
- Regular hospital visits, blood tests, and scans will be part of taking part.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is for adults aged 18 or over who have pancreatic cancer that has spread to other parts of the body. Importantly, their cancer must have a specific genetic change called a 'KRAS G12D mutation'. This means your cancer cells have a particular fault that the study drug is designed to target.
To join, you also need to be generally well enough to take part in a clinical trial, as judged by your doctor. Your body's organs, like your kidneys and liver, need to be working well enough. You must not have started any treatment for your widespread pancreatic cancer yet, and you need to be able to take medicines by mouth.
Some reasons you might not be able to join include if you've already had certain treatments for your widespread cancer, if your cancer has spread to your brain in an untreated way, or if you've had major surgery recently.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Has your pancreatic cancer spread to other parts of your body?
- Has your cancer been tested for the 'KRAS G12D mutation' and found to have it?
- Have you NOT started any treatment for your widespread pancreatic cancer yet?
- Are you generally well enough for a clinical trial, as decided by your doctor?
- Are you able to take medicines by mouth?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of two groups, like flipping a coin. You won't know which group you're in, and neither will your doctor – this is called a 'double-blind' study. One group will receive zoldonrasib plus chemotherapy, and the other will receive a dummy pill (placebo) plus chemotherapy. The type of chemotherapy given will be chosen by your doctor.
Throughout the study, you'll have regular visits to the hospital or clinic. These visits will involve blood tests, scans (like CT scans) to check your cancer, and check-ups with your study doctor or nurse. These assessments help the researchers monitor your health, how you're responding to treatment, and any side effects. You'll take the study drug (zoldonrasib or placebo) by mouth, alongside your chemotherapy infusions. The total length of your participation will depend on how you respond to the treatment, but you'll have regular follow-up for some time even after you stop taking the study medication.
Potential risks and benefits
Locations (19)
- Mayo Clinic ArizonaVerified postcodePhoenix, United States· Recruiting
- The University of Arizona Cancer Center-North CampusVerified postcodeTucson, United States· Recruiting
- Yale UniversityVerified postcodeNew Haven, United States· Recruiting
- University of FloridaVerified postcodeGainesville, United States· Recruiting
- Mayo Clinic FloridaVerified postcodeJacksonville, United States· Recruiting
- Moffitt Cancer CenterVerified postcodeTampa, United States· Recruiting
- Piedmont Cancer InstituteVerified postcodeAtlanta, United States· Recruiting
- Piedmont HealthcareVerified postcodeAtlanta, United States· Recruiting
- University of Chicago Medical CenterVerified postcodeChicago, United States· Recruiting
- Johns Hopkins UniversityVerified postcodeBaltimore, United States· Recruiting
- Dana Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Mayo Clinic RochesterVerified postcodeRochester, United States· Recruiting
Common questions
What is a 'KRAS G12D mutation'?
It's a specific change found in the genes of some cancer cells that helps them grow. The study drug is designed to target this change.
What does 'double-blind' mean?
It means neither you nor your doctors will know if you're getting the new drug or the dummy pill. This helps ensure the study results are fair and unbiased.
Why is a dummy pill (placebo) used?
It helps researchers accurately compare the effects of the new drug against standard chemotherapy alone, to see if adding the new drug makes a real difference.
What kinds of chemotherapy might I receive?
Your doctor will choose a standard chemotherapy treatment, which could be regimens like FOLFIRINOX (often called mFFX) or gemcitabine plus nab-paclitaxel (often called GnP).
Will I have to pay to join the study?
No, all study-related treatments, tests, and medical visits will be provided at no cost to you.
How to find out more
Revolution Medicines Study Director
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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