A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
This research study is for adults with a specific type of advanced lung cancer called non-small cell lung cancer (NSCLC) that has a KRAS G12C gene change. If your cancer has spread or can't be cured by surgery or radiation, this study might be for you. We're comparing two different treatment approaches. One group will receive a new drug called Divarasib along with Pembrolizumab. The other group will receive Pembrolizumab combined with Pemetrexed and either Carboplatin or Cisplatin, which are standard chemotherapy drugs. The main goal is to see how well these combinations work at treating the cancer and to understand their side effects, helping us find better first-time treatments for this particular lung cancer.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned research project to test new treatments. It's specifically for people who have a type of lung cancer called non-small cell lung cancer (NSCLC). This isn't just any NSCLC; it's for cases where the cancer has a particular change in a gene called 'KRAS G12C'. This gene change can make the cancer grow and spread.
The main idea behind this study is to find out if a new combination of drugs works better and is safer than a more standard combination for treating this specific lung cancer for the first time. One group of patients will receive a new drug called Divarasib, along with Pembrolizumab. Pembrolizumab is an immunotherapy that helps your own immune system fight cancer. The other group will receive Pembrolizumab combined with Pemetrexed and either Carboplatin or Cisplatin. These are established chemotherapy drugs. By comparing these two approaches, researchers hope to improve treatment options.
Taking part in a study like this helps doctors learn more about diseases and develop new and often more effective treatments for the future. The results from this study could be very important for people with KRAS G12C-mutated non-small cell lung cancer, potentially offering a new way to manage their condition.
Key takeaways
- This study is for advanced non-small cell lung cancer with a specific KRAS G12C gene change.
- It's testing two different drug combinations as a first treatment.
- One combination includes a new drug, Divarasib; the other uses standard chemotherapy drugs.
- It aims to find out which treatment is more effective and safer.
- Participation involves regular hospital visits for treatment, tests, and monitoring.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you would need to be an adult with a specific type of advanced non-small cell lung cancer that has a KRAS G12C gene change. Your cancer also needs to have started spreading or can't be fully cured by surgery or radiation treatment. You'll need to be generally well enough to manage the treatment, meaning you can carry out most everyday activities without too much difficulty. This is often described using a scale where 0 or 1 is generally well.
There are also some things that might mean you can't join. For example, if you've already had certain types of treatment for your advanced lung cancer, or if your cancer has spread to your brain causing active symptoms, you might not be eligible. If you have another type of cancer gene change that has a specific treatment, this study might not be suitable either. The study also cannot include people with certain other health conditions or those taking specific medications that could interfere with the study drugs.
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?
- Do you have advanced non-small cell lung cancer?
- Has your doctor confirmed your cancer has the 'KRAS G12C' gene change?
- Have you NOT had any previous treatment for your advanced lung cancer?
- Are you generally well enough to do most everyday activities?
- Do you not have active, spreading cancer in your brain causing symptoms?
What does participation involve?
If you decide to take part in this study, you will be assigned to one of the two treatment groups. You'll receive your study medication, which could be Divarasib and Pembrolizumab, or Pembrolizumab with Pemetrexed and either Carboplatin or Cisplatin. You will have regular visits to the hospital or clinic for blood tests, check-ups, and to see how you are responding to treatment. These visits will help the doctors monitor your health and any side effects.
Throughout the study, you'll have scans (like CT scans) to see if the cancer is shrinking or staying stable. There will be careful recording of any side effects you experience. The treatment will continue as long as it is working for you and you are not experiencing severe side effects. After the main treatment, there will be follow-up appointments to keep track of your health long-term. The total duration of your involvement could vary, but follow-up can last for several months or even longer.
Potential risks and benefits
Locations (240)
- Alaska Oncology and HematologyVerified postcodeAnchorage, United States· Recruiting
- City of Hope - PhoenixVerified postcodeGoodyear, United States· Recruiting
- Marin Cancer Care IncVerified postcodeGreenbrae, United States· Recruiting
- Hoag Memorial HospitalVerified postcodeNewport Beach, United States· Recruiting
- Palo Alto Medical Foundation Research CenterVerified postcodePalo Alto, United States· Recruiting
- Sutter Institute for Medical ResearchVerified postcodeRoseville, United States· Recruiting
- California Pacific Medical CenterVerified postcodeSan Francisco, United States· Recruiting
- Florida Cancer Specialists - SOUTH - SCRI - PPDSVerified postcodeFort Myers, United States· Recruiting
- University of Florida Health at ShandsVerified postcodeGainesville, United States· Recruiting
- BioResearch PartnerVerified postcodeHialeah, United States· Recruiting
- Memorial Healthcare System - Memorial Regional HospitalVerified postcodeHollywood, United States· Recruiting
- Sylvester Comprehensive Cancer CenterVerified postcodeMiami, United States· Recruiting
Common questions
What is KRAS G12C-mutated lung cancer?
It's a specific type of non-small cell lung cancer where the cancer cells have a particular genetic change in the KRAS gene, which can make the cancer grow.
What does 'first-line treatment' mean?
It means this study is testing treatments that would be given as the initial therapy for your advanced lung cancer, before any other specific treatments for the advanced stage.
Will I know which treatment I'm getting?
In this type of study, you'll be assigned to one of the treatment groups. The doctors and study team will discuss this process with you in detail.
How long will I be on the study treatment?
You will receive the study treatment for as long as it is helping your cancer and you are not experiencing unacceptable side effects. There might also be follow-up after treatment stops.
What if I feel unwell during the study?
You'll have regular contact with the study team, and you should always report any new or worsening symptoms immediately so they can assess and help manage them.
How to find out more
Reference Study ID Number: CO45042 https://forpatients.roche.com/
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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