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A Study Comparing PF-08046054 to Docetaxel in Adults with Previously Treated PD-L1 Positive Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Non-Small Cell Lung Cancer, which is a type of cancer that affects the lungs. The study involves adults whose cancer has already been treated before but has continued to grow or come back. The cancer must show a certain protein marker called PD-L1 on at least one percent of the tumor cells. The study will compare two different treatments to see which one works better. One treatment is an investigational medicine with the code name PF-08046054, also called SGN-PDL1V, which is given through a vein. The other treatment is docetaxel, which is an approved cancer medicine also given through a vein. Some people in the study may have specific genetic changes in their cancer, such as EGFR mutations or ALK translocations, and must have already received targeted treatments for these changes before joining this study.

The main purpose of this study is to compare how long people live when treated with the investigational medicine compared to docetaxel. The study will look at this in all people whose tumors have PD-L1 levels of at least one percent, and also specifically in those whose tumors have PD-L1 levels of fifty percent or higher. People taking part will be randomly assigned to receive either the investigational medicine or docetaxel. The study will also look at other things like how well the tumors respond to treatment, how long any response lasts, and what side effects occur with each treatment.

During the study, participants will receive their assigned treatment for up to sixty months. Those receiving the investigational medicine will get it at a dose based on their body weight, while those receiving docetaxel will get it at a dose based on their body surface area. The study team will regularly check how the cancer is responding to treatment and monitor for any side effects. Participants will also be asked about their quality of life and any symptoms they are experiencing. Blood samples will be taken from those receiving the investigational medicine to measure drug levels in the body and to check for immune responses to the medicine. Tumor tissue samples will also be collected for testing to help understand how the treatments work.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and enrollment

    Your diagnosis of non-small cell lung cancer will be confirmed through tissue analysis. This cancer must be at an advanced stage that cannot be surgically removed or has spread to other parts of the body.

    A test will be performed on your tumor tissue to measure the level of a protein called PD-L1. Your tumor must have at least 1% of cells expressing this protein to participate in this study.

    Tissue samples from your tumor will be collected for laboratory analysis. This can be either previously collected tissue, preferably from within the last 12 months, or a new tissue sample obtained through a biopsy procedure if medically appropriate.

    Your previous cancer treatments will be reviewed. You must have received platinum-based chemotherapy (a type of cancer treatment using platinum-containing drugs) and treatment with a PD-L1 antibody (a type of immunotherapy), and your cancer must have progressed or returned after these treatments.

  2. Step 2

    Random assignment to treatment group

    You will be randomly assigned to one of two treatment groups. This means that neither you nor your doctor will choose which treatment you receive.

    One group will receive the investigational medicine called PF-08046054, which is an antibody attached to a cancer-fighting drug.

    The other group will receive docetaxel, a standard chemotherapy medication used for lung cancer treatment.

  3. Step 3

    Treatment administration

    If you are assigned to receive PF-08046054, the medication will be administered through an intravenous infusion, which means it will be delivered directly into your vein over a period of time.

    If you are assigned to receive docetaxel, this medication will also be given through an intravenous infusion into your vein.

    The specific dosage, frequency of administration, and duration of treatment will be determined according to the study protocol and your individual medical situation.

    You will receive repeated cycles of treatment as long as the treatment is providing benefit and you are not experiencing unacceptable side effects.

  4. Step 4

    Regular monitoring and assessments

    Throughout the study, your cancer will be monitored through imaging scans to assess whether the tumor is shrinking, staying the same, or growing.

    Blood samples will be collected at specific times during treatment. If you are receiving PF-08046054, these samples will measure the levels of the medication and its components in your blood, including measurements at the end of each infusion and before the next dose.

    You will be monitored for any side effects or adverse reactions to the treatment. All side effects will be recorded, including their type, severity, and relationship to the study medication.

    If you are receiving PF-08046054, your immune response to the medication will be assessed by testing whether your body has developed antibodies against the treatment.

  5. Step 5

    Quality of life assessments

    You will be asked to complete questionnaires at regular intervals to assess your quality of life and overall well-being.

    These questionnaires will ask about your general health status, your ability to perform daily activities, and your physical functioning.

    You will also answer questions specifically related to lung cancer symptoms, such as difficulty breathing, cough, and chest pain.

    The questionnaires will help assess any changes in your symptoms and quality of life during the treatment period.

  6. Step 6

    Ongoing treatment and follow-up

    Your treatment will continue as long as it is effective and you are tolerating it without serious side effects.

    Your doctor will regularly evaluate your response to treatment based on imaging scans and clinical assessments.

    The duration of your participation in the study will depend on how your cancer responds to treatment and your overall health status.

    Long-term survival information will be collected as part of the study to compare the effectiveness of the two treatments.

Who can join the trial?

12 criteria

  • You must have a confirmed diagnosis of non-small cell lung cancer, which is a type of lung cancer, that is either locally advanced and cannot be removed by surgery or has spread to other parts of the body
  • Your cancer must not be suitable for a treatment combination called definitive chemoradiotherapy, which is a specific type of cancer treatment using both chemotherapy medicines and radiation therapy together
  • Your tumor must not have a neuroendocrine component, which is a specific type of cell that is not allowed in this study
  • Your tumor must show at least 1 percent expression of a protein called PD-L1, which will be tested in a laboratory using a specific testing method
  • You may participate even if your cancer has certain genetic changes, such as EGFR mutations or ALK translocations, which are specific alterations in your cancer cells
  • You must be able to provide tissue samples from your tumor for testing, either from previously collected samples or from a new biopsy, which is a procedure to remove a small piece of tissue
  • If your cancer does not have the genetic changes mentioned above, you must have received platinum-based chemotherapy, which is a type of cancer medicine containing platinum, and a medicine called a PD-L1 monoclonal antibody, which is a treatment that helps your immune system fight cancer
  • If your cancer does not have genetic changes and you received chemotherapy after surgery or with radiation, your cancer must have gotten worse within 6 months after finishing that treatment, and you must have received the PD-L1 antibody treatment at some point
  • If your cancer has genetic changes like EGFR or ALK, you must have received at least one approved targeted therapy for these changes, and your doctor must believe that additional targeted therapy would not be beneficial for you
  • If your cancer has genetic changes, you must have received platinum-based chemotherapy for cancer that has spread or returned, or your cancer must have gotten worse within 6 months after finishing chemotherapy given after surgery or with radiation
  • You can be male or female
  • You must be an adult to participate in this study

Who cannot join the trial?

3 criteria

  • The specific reasons why patients cannot participate in this study have not been provided in the available information.
  • If you are considering joining this clinical trial, your doctor will review all requirements with you to determine if you are eligible to participate.
  • Generally, clinical trials have specific rules about who can and cannot join to ensure the safety of participants and the accuracy of the study results.
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Investigated drugs

  • PF-08046054

    (also known as SGN-PDL1V) is an experimental medication being tested in this clinical trial. It is designed to work by targeting a specific protein called PD-L1 that is found on some cancer cells. This medication is being studied to see if it can help treat non-small-cell lung cancer in patients who have already received other treatments.

  • Docetaxel

    is a chemotherapy medication that is already approved and used to treat various types of cancer, including lung cancer. It works by stopping cancer cells from dividing and growing. In this trial, it is being used as the comparison treatment to see how well the experimental medication works in comparison.

What is already known about the treatment

  • PF-08046054/SGN-PDL1V

    This is an experimental cancer medication currently being tested in clinical trials for treating non-small cell lung cancer that has been previously treated with other therapies. It is designed for patients whose tumors show positive levels of a protein called PD-L1, which helps cancer cells hide from the immune system. The medication works by targeting and blocking PD-L1, allowing the body's immune system to recognize and attack cancer cells more effectively. This drug belongs to a class of medicines called immune checkpoint inhibitors, which help the immune system fight cancer.

  • Docetaxel

    This is an approved chemotherapy medication given through an intravenous infusion into a vein, commonly used to treat various types of cancer including non-small cell lung cancer. It is an established treatment option in medical practice and is widely documented in medical literature as a standard therapy for patients whose cancer has progressed after initial treatment. The medication works by interfering with the internal structure of cancer cells, preventing them from dividing and multiplying, which ultimately leads to cancer cell death. Docetaxel belongs to a group of chemotherapy drugs called taxanes, which are derived from compounds originally found in yew tree bark.

Investigated diseases

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer is a type of cancer that develops in the lungs and is the most common form of lung cancer. The disease begins when cells in the lung tissue start growing abnormally and uncontrollably, forming tumors that can interfere with normal lung function. As the cancer progresses, it can spread to nearby tissues and lymph nodes in the chest. In more advanced stages, the cancer cells may travel through the bloodstream or lymphatic system to other parts of the body, such as the bones, liver, or brain. The disease can cause symptoms like persistent cough, chest pain, shortness of breath, and coughing up blood. Non-Small Cell Lung Cancer grows and spreads more slowly than small cell lung cancer, but it still requires medical attention as it can significantly affect breathing and overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521281-97-00Protocol codeC5851005Estimated enrolment680 patientsSponsorPfizer Inc.

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