A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
This study is testing a new medicine called PF-08046054 against a common treatment, Docetaxel, for adults with non-small cell lung cancer. Participants will have cancer that has spread or cannot be removed by surgery or radiation, and has previously been treated. They must also have a specific marker (PD-L1) on their cancer cells. The aim is to see if the new medicine works better or is safer than the standard treatment. People will be randomly assigned to receive either the new medicine or Docetaxel through a drip, and their progress will be carefully monitored for up to 5 years.
At a glance
What is this study about?
You're looking at information about a clinical trial that's studying a new medicine for a type of lung cancer called non-small cell lung cancer (NSCLC). This trial is for people whose cancer has already been treated and has certain features. The main goal is to find out if a new medicine, called PF-08046054, works better than a standard treatment for lung cancer called Docetaxel.
Imagine that doctors want to discover if a new car is better than an older, trusted one. To do this, they’d get a group of drivers and give half the new car and half the old car, then compare how they perform. This study works in a similar way. They're comparing two treatments to see which one is more effective at treating this specific type of lung cancer. This is important because new and better treatments could offer more options for people living with NSCLC.
NSCLC is a broad term, and this study focuses on a specific group. It includes people whose cancer has spread (metastatic) or cannot be treated with surgery or strong radiation. Also, their cancer cells must show a marker called PD-L1, which helps doctors understand how the cancer might respond to certain treatments. This study is considered a 'Phase 3' trial, which means it's one of the final steps before a new medicine might become widely available.
Key takeaways
- Compares a new medicine (PF-08046054) to a standard one (Docetaxel) for lung cancer.
- For adults with previously treated non-small cell lung cancer that has spread or can't be removed, and has the PD-L1 marker.
- Treatments are given through a drip (IV infusion) in cycles.
- You'll be randomly assigned to one of the two treatment groups.
- Study participation could last up to 5 years with regular monitoring.
- This is a Phase 3 study, aiming to see if the new medicine is better.
Who may be eligible?
To join this study, you would need to be an adult with a diagnosis of non-small cell lung cancer that has either spread to other parts of your body, or cannot be removed by surgery or strong radiation treatment. Importantantly, your cancer must also show a specific marker called PD-L1 on at least 1% of the cancer cells.
You would also need to have received previous treatments for your lung cancer, and the cancer would have either worsened during or after those treatments, or you couldn't tolerate them. This includes previous chemotherapy and, if your cancer has specific genetic changes, previous targeted treatments. If your cancer returned quickly after initial treatment, that could also make you eligible.
There are also some things that would mean you couldn't join. For example, if your type of lung cancer has certain 'neuroendocrine' features, you wouldn't be able to participate. The study team will look closely at your medical history and test results to see if this study is suitable for you.
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 an adult (18 or older)?
- Do you have a type of lung cancer called non-small cell lung cancer that has spread or can't be fully removed?
- Has your lung cancer been treated before, and did it come back or get worse, or were you unable to continue previous treatments?
- Does your cancer show the PD-L1 marker (your doctor will know this from tests)?
- Are you able to provide a tissue sample (biopsy) of your cancer if needed for testing?
What does participation involve?
If you decide to join this study, it's a bit like taking part in a carefully planned experiment. You'd be randomly assigned to one of two groups – like flipping a coin – so neither you nor your doctor chooses which treatment you get. One group will receive the new medicine, PF-08046054, and the other will receive the standard medicine, Docetaxel.
Both medicines are given through a drip into your vein (IV infusion). If you're in the PF-08046054 group, you'll have these infusions twice every 21 days. If you're in the Docetaxel group, you'll have an infusion once every 21 days. The study team will see you regularly at the clinic to check how you're doing, monitor your health, and see how your cancer is responding to the treatment.
Participation in the study could last for a long time, potentially up to 5 years, if the treatment is helping to control your lung cancer. This long follow-up allows the researchers to gather a lot of important information about the medicines.
Potential risks and benefits
Locations (305)
- Alabama OncologyVerified postcodeAlabaster, United States· Recruiting
- Alabama OncologyVerified postcodeBessemer, United States· Recruiting
- Alabama Oncology, Bruno Cancer CenterVerified postcodeBirmingham, United States· Recruiting
- Alabama OncologyVerified postcodeBirmingham, United States· Recruiting
- Alabama OncologyVerified postcodeBirmingham, United States· Recruiting
- Alabama OncologyVerified postcodeBirmingham, United States· Recruiting
- Alabama OncologyVerified postcodeBirmingham, United States· Recruiting
- Southern Cancer CenterVerified postcodeDaphne, United States· Recruiting
- Southern Cancer Center, PCVerified postcodeFoley, United States· Recruiting
- Alaska Oncology and HematologyVerified postcodeAnchorage, United States· Recruiting
- Highlands Oncology Group, PAVerified postcodeFayetteville, United States· Not yet recruiting
- Highlands Oncology Group, PAVerified postcodeRogers, United States· Not yet recruiting
Common questions
What is PD-L1?
PD-L1 is a protein found on cancer cells that can help them hide from the body's immune system. Knowing if your cancer has this marker helps doctors choose the right treatments.
What does 'randomly assigned' mean?
It means you'll be put into one of the treatment groups by chance, like flipping a coin. This ensures the study results are fair and accurate.
What is an 'IV infusion'?
An IV infusion is when medicine is given directly into your bloodstream through a small tube inserted into a vein, usually in your arm. It's often called a 'drip'.
What is a 'Phase 3' trial?
Phase 3 is usually the final step of testing a new medicine in a large group of people to confirm its effectiveness and compare it to existing treatments before it can be made widely available.
How long would I be in the study?
If the treatment is working well for you, you could be in the study for up to 5 years. You'll have regular check-ups during this time.
How to find out more
Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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