A Phase 3 Study of Pembrolizumab in Combination with Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants with Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC)
This research study is investigating new treatment options for people with advanced non-small cell lung cancer, a common type of lung cancer. It compares two groups: one receiving standard chemotherapy (a mix of pemetrexed and either carboplatin or cisplatin) along with a drug called pembrolizumab, followed by olaparib. The other group receives the same chemotherapy and pembrolizumab, but then continues with pemetrexed. The study aims to find out if the new combination of treatments helps people live longer without their cancer getting worse, and whether it improves their overall quality of life. Participants will be closely monitored for side effects and how they are feeling.
At a glance
What is this study about?
This clinical trial is designed to investigate a new approach to treating advanced non-small cell lung cancer, specifically the 'non-squamous' type. This is a common form of lung cancer that has spread to other parts of the body (Stage IV).
The study compares two different treatment plans. Both plans start with a combination of standard chemotherapy drugs (pemetrexed and either carboplatin or cisplatin) alongside a targeted therapy called pembrolizumab (also known as Keytruda). Pembrolizumab is an immunotherapy drug that helps your body's immune system fight cancer. After an initial period, the treatments differ. One group will then receive maintenance olaparib, another targeted drug, while the other group will continue with maintenance pemetrexed.
The main goals of the study are to see if the new treatment combinations can prevent the cancer from growing for longer and help people live longer. The researchers will also be carefully monitoring how participants feel, their quality of life, and any side effects they might experience. This information will help doctors understand if these new combinations are a better option for future patients.
Key takeaways
- This study explores new combinations of medicines for advanced lung cancer.
- It aims to see if these new treatments can slow cancer growth and extend lives.
- The study also looks at how treatments affect patients' quality of life.
- It combines chemotherapy with newer drugs called pembrolizumab and olaparib.
- Participation involves regular hospital visits, treatments, and health checks.
Who may be eligible?
To be considered for this study, you'll need to meet certain requirements. The study is open to both men and women, and you must be at least 18 years old. There is no upper age limit, meaning older adults can also participate.
Crucially, you must have been diagnosed with advanced non-small cell lung cancer (the 'non-squamous' type) that has spread to other parts of your body, and you must not have received any previous treatment for this advanced stage of your cancer. Your medical team will also need to review your overall health and other specific medical details to ensure it's safe for you to take part.
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 (non-squamous type) that has spread?
- Have you NOT received any prior treatment for this advanced stage of lung cancer?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Are you generally well enough to undergo cancer treatment (your doctor will check this)?
What does participation involve?
Taking part in this study would involve regular hospital visits for treatments and check-ups. You would receive a combination of medicines through infusions (like a drip) and possibly some as tablets, depending on which treatment group you are in. Your doctors and nurses will closely monitor your health, perform regular scans to see how the cancer is responding, and ask you about any side effects you might have.
Throughout the study, you'll complete questionnaires about how you're feeling and your quality of life. The treatments themselves will last for a period, followed by ongoing monitoring and follow-up appointments to track your progress and long-term health. The total duration of participation, including follow-up, will be determined by the study protocol, but it's important to understand this is a commitment over an extended period.
Potential risks and benefits
Locations (6)
- —UnverifiedRomania
- —UnverifiedAustria
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What type of lung cancer is this study for?
This study is for advanced non-small cell lung cancer, specifically the 'non-squamous' type, which has spread to other parts of the body.
What are pembrolizumab and olaparib?
Pembrolizumab is an immunotherapy drug that helps your immune system fight cancer. Olaparib is a targeted therapy that works by interfering with cancer cells' ability to repair themselves.
Will I know which treatment I'm getting?
In some studies, participants don't know which treatment group they are in. The study team will explain how this works for this specific trial.
How long will I be in the study?
The study involves initial treatment periods followed by ongoing monitoring. The full duration for each participant will vary but will involve a significant period of follow-up.
What if I experience side effects?
Your health will be closely monitored, and your medical team will help manage any side effects you might experience during the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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