AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
This research is investigating a new treatment called PF-08634404. It's being tested alongside standard chemotherapy for adults who have locally advanced or metastatic non-small cell lung cancer. This means the cancer has spread from where it started. The study wants to compare the new drug combination with another existing treatment, pembrolizumab plus chemotherapy, which is already used for this type of cancer. The main goals are to see how long patients live and if the cancer grows or spreads later, for both treatment groups. Researchers will also look at side effects, how the drugs behave in the body, and how patients' quality of life changes. It's a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available.
At a glance
What is this study about?
This important study is looking into new ways to treat advanced non-small cell lung cancer. This is a type of lung cancer that has either grown into nearby tissues (locally advanced) or has spread to other parts of the body (metastatic).
The study is testing a new medicine called PF-08634404. This new medicine is given alongside regular chemotherapy, which is a common way to treat cancer. Researchers want to see if this new combination works better or just as well as another established treatment, which is pembrolizumab given with chemotherapy, and if it's safe for patients.
The main things the researchers are trying to find out are how long people live with each treatment and how long it takes before the cancer starts to grow or spread again. They will also carefully monitor any side effects, how these treatments affect daily life, and the overall well-being of the patients taking part.
Key takeaways
- This study is testing a new drug for advanced lung cancer.
- It compares two treatment combinations: new drug + chemotherapy vs. existing drug + chemotherapy.
- The main goals are to see how long patients live and how long their cancer is kept under control.
- It's a 'Phase 3' study, meaning it's a key step in developing new treatments.
- Adults with locally advanced or metastatic non-small cell lung cancer may be eligible.
Who may be eligible?
To join this study, you must be an adult aged 18 years or older. Men and women are both welcome to take part.
More specific details about your health and your cancer will be discussed with you by the study team. This will help them decide if this study is the right fit for you and safe for you to participate in. For example, they will need to check the exact type and stage of your lung cancer, and your general health condition.
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 or older?
- Do you have locally advanced or metastatic non-small cell lung cancer?
- Are you generally well enough to participate in a clinical trial?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two treatment groups, like flipping a coin for fairness. Neither you nor your doctor would know which treatment you are receiving (this is called 'double-blind'). You would receive either the new drug (PF-08634404) with chemotherapy, or pembrolizumab with chemotherapy. The chemotherapy drugs used could include paclitaxel, albumin-bound paclitaxel, carboplatin, or pemetrexed, depending on your specific situation. You would also receive a salt water solution (sodium chloride) which is commonly used to administer medications.
Throughout the study, you would have regular visits for examinations, blood tests, and scans to check how you're responding to the treatment and to monitor for any side effects. Researchers will also take samples to understand how the new drug works in your body. We don't have an exact total duration specified, but clinical trials for advanced cancer often involve treatments continuing as long as they are beneficial or until side effects make it necessary to stop, with follow-up appointments continuing for some time after treatment.
Potential risks and benefits
Locations (8)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedHungary
- —UnverifiedGreece
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedGermany
Common questions
What is 'Non-Small Cell Lung Cancer'?
It's the most common type of lung cancer. This study focuses on situations where the cancer has spread or is advanced.
What does 'Phase 3' mean for a study?
Phase 3 is one of the final stages of testing a new medicine. It means the drug has already shown promise in earlier studies and is now being compared to existing treatments on a larger number of patients.
Will I know which treatment I'm getting?
No, this is a 'double-blind' study, meaning neither you nor your doctor will know if you're receiving the new drug combination or the established treatment. This helps ensure the results are unbiased and reliable.
What kind of side effects might I experience?
As with any cancer treatment, there's a possibility of side effects. These will be carefully monitored and managed by the study team, and you will be given more detailed information before you decide to join.
What is chemotherapy?
Chemotherapy uses powerful medicines to kill cancer cells or slow their growth. It is a common treatment for many types of cancer.
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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