PD-L1 is a protein found in human cells which stops the body’s immune system from attacking its own healthy cells, but it is also found in some cancers. The PADL1NK-005 clinical trial is exploring a study medicine which is designed to target PD-L1 on tumor cells and deliver an anticancer drug to eliminate them.
PADL1NK-005 is exploring a study medicine that is designed to deliver a targeted treatment for non-small cell lung cancer (NSCLC)
PD-L1 is a protein found in human cells which stops the body’s immune system from attacking its own healthy cells, but it is also found in some cancers. The PADL1NK-005 clinical trial is exploring a study medicine which is designed to target PD-L1 on tumor cells and deliver an anticancer drug to eliminate them.
Your participation in this clinical trial could help advance a potential medicine for people with NSCLC. Thank you for taking the time to learn more.
Who may participate
This trial is enrolling adults 18 years of age or older who:
- Have been diagnosed with advanced NSCLC (Stage IIIB, IIIC or IV)
- …which has been identified as PD-L1-positive
- …and which has worsened despite previous treatment
There will be other requirements that the trial team will discuss with you
Condition
Non-small cell lung cancer
Age
18+ years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
You will be assigned by chance to receive either the study medicine or a standard chemotherapy drug called docetaxel which is an established treatment for people with NSCLC. There is no placebo (inactive treatment) in this trial.
The study medicine is given by intravenous infusions (directly into the bloodstream via a small tube and needle) 2 times every 3 weeks. Docetaxel is given by intravenous infusions once every 3 weeks.
The total length of your participation will depend on how you and the cancer respond, any side effects you may experience, and your personal decision to remain in the clinical trial. The maximum duration is 5 years.
Length of study treatment
Depends on how the cancer responds and how well the study medicine is tolerated. The length of study treatment and follow-up may last up to 5 years
Number of visits
About once or twice every 3 weeks
Long-term follow up
Visits or calls every 6 weeks for the first 48 weeks, then every 12 weeks thereafter
About the study medicine
About the study medicine
Participation matters
Participation matters
No one’s body is exactly the same. Many factors, including genetics, race, ethnicity, and gender, can impact how people respond to medicine. That is why it is important that clinical trials include people of all backgrounds.
The greater the representation among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.
Frequently asked questions
What are the possible benefits of participating?
There are no guaranteed benefits to joining a clinical trial. You will have regular visits to the trial center and your health and cancer will be closely monitored for the duration of the clinical trial. Participating in clinical trials helps researchers learn more about the disease and advance potential treatment options.
What are the possible risks of participating?
Participant safety is the top priority of this clinical trial. It is possible your condition or health may improve, worsen, or stay the same. Your trial doctor will discuss all the possible risks and benefits of participating with you before you choose to enroll.
What is Informed Consent?
Informed consent is one of the most important tools to help you understand how your rights, safety, and well-being will be addressed throughout the trial. During the informed consent discussion, you will be given all details about the trial, including potential benefits and risks of taking part. You will also be given a document summarizing this information, which you will sign to confirm that you would like to take part in the clinical trial.
What treatment will I receive?
This clinical trial is controlled, which means a comparison (control) group will be used. A comparator medicine is a “standard of care” or the established treatment that is currently used for people with a disease (such as NSCLC). In this trial, docetaxel is the comparator medicine.
Participants will receive either the study medicine or docetaxel. The study medicine is given by intravenous infusions (directly into the bloodstream via a small tube and needle) 2 times every 3 weeks. Docetaxel is given by intravenous infusions once every 3 weeks.
Participants will be assigned to a treatment group by chance (like flipping a coin) rather than by choice. This is called randomization, and it is one way to help avoid bias in a clinical trial.
