This study is designed to compare the effectiveness and safety of two different treatment approaches for adults with Non-Small Cell Lung Cancer that is either Locally Advanced or Metastatic. This means the cancer is either growing into nearby tissues or has spread to other parts of the body. The purpose of the study is to determine if a new medicine, PF-08634404, used along with Chemotherapy, works better than a current treatment combining Pembrolizumab with chemotherapy.
The treatments involve medications administered through an Intravenous line, which is a method of delivering medicine directly into a vein. One group receives the study drug PF-08634404 along with a combination of chemotherapy drugs, which may include Paclitaxel, Carboplatin, or Pemetrexed. Another group receives Pembrolizumab combined with these chemotherapy drugs. Some participants may also receive Paclitaxel Albumin-Bound or a Placebo involving Sodium Chloride. During the study, participants will be monitored to see how they respond to the medicines and to track their Overall Survival and Progression-Free Survival, which refers to the length of time during and after treatment that a person lives with the disease without it getting worse.
Who Can Join the Study?
You must be 18 years of age or older.
You must have a confirmed diagnosis of locally advanced (cancer that has spread to nearby parts of the body) or metastatic (cancer that has spread to distant parts of the body) non-small cell lung cancer.
The cancer must be squamous or non-squamous in type and cannot be treated by complete surgical resection (the complete removal of the tumor through surgery) or curative chemoradiation (a combination of chemotherapy and radiation therapy intended to cure the disease).
You must have tumor tissue available, such as a paraffin block (a small sample of tissue preserved in wax) or slides from a biopsy (a procedure to remove a small piece of tissue for testing).
Your PD-L1 status must be known, which refers to a specific protein level on your cancer cells that helps doctors determine if certain treatments will work.
You must have measurable disease, meaning the tumors can be clearly seen and measured on scans according to standard medical rules called RECIST v1.1.
Your ECOG PS score must be 0 or 1, which is a scale used to measure how well you can perform daily activities and your overall physical strength during the illness.
Your expected survival must be 12 weeks or longer.
Who Cannot Join the Study?
You cannot participate if you have certain genetic mutations (known as AGAs) such as EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET, because there are already specific approved treatments available for these.
You are ineligible if you had major surgery within the last 4 weeks or minor surgery within the last 3 days.
You cannot join if you have a history of severe bleeding problems or coagulation dysfunction, which means your blood does not clot normally.
You are excluded if you had esophageal varices (swollen veins in the food pipe), severe ulcers, unhealed wounds, gastrointestinal perforation (a hole in the digestive tract), abdominal fistula (an abnormal connection between organs), gastrointestinal obstruction (a blockage in the intestines), abdominal abscess (a collection of pus), or stomach bleeding within the last 6 months.
You cannot participate if you have an active infection, including HIV, HBV (Hepatitis B), or HCV (Hepatitis C).
You are ineligible if you have a history of immunodeficiency, which means your immune system does not work correctly to fight infections.
You cannot join if you have any medical or mental health conditions, including suicidal thoughts or behavior within the last 5 years, or any health issues that make participating in the study unsafe.
You are excluded if you have had previous cancer treatments, such as immunotherapy, radiotherapy (radiation treatment) to the lungs within the last 6 months, or certain types of targeted therapies.
You cannot participate if you previously had immune-related adverse events, which are side effects caused by the immune system attacking healthy cells, that required you to stop treatment or take immunosuppressive therapy (medicine to dampen the immune system).
You are ineligible if you have taken blood thinners (anticoagulants or antiplatelet therapy) very recently, or if you have received a live vaccine within the last 4 weeks.
You cannot join if you are currently taking high-dose steroids or other prohibited medications.
You are excluded if you are breastfeeding, or if you are a person capable of becoming pregnant or a male who is unwilling to use contraception (birth control).
You cannot participate if you have active lesions in the Central Nervous System (CNS), which refers to the brain or spinal cord, though some small, inactive brain metastases (cancer that spread to the brain) may be allowed.
You are ineligible if you have a high risk of hemorrhage (severe bleeding) or a fistula (an abnormal opening in the body).
You cannot join if you have had another type of cancer within the last 3 years or if there is any sign of a previous cancer still present.
You are excluded if you still have unresolved side effects from previous cancer treatments that have not improved to a mild level (Grade 0 or 1).
You cannot participate if you have a history of severe allergies to the study medicine or to antibodies (proteins used in certain treatments).
You are ineligible if you have had an organ transplant or a stem cell transplant.
You cannot join if you have certain lung conditions, such as ILD or pneumonitis (inflammation of the lung tissue) or if your lung function test (DLCO) is too low.
You are excluded if you have had uncontrolled health problems in the last 6 months, such as heart disease, stroke, high blood pressure, diabetes, or blood clots.
Paclitaxel is a type of chemotherapy medicine used to treat cancer by stopping cancer cells from growing and dividing.
PF-08634404 is an experimental treatment being studied to see if it helps fight cancer when combined with other medicines.
Paclitaxel albumin-bound is a specialized form of chemotherapy designed to deliver the medicine more effectively to cancer cells.
Pembrolizumab is an immunotherapy medicine that helps the body’s own immune system recognize and attack cancer cells.
Carboplatin is a chemotherapy drug used to slow or stop the growth of cancer cells.
Pemetrexed is a chemotherapy medication used to treat certain types of cancer by interfering with the way cancer cells grow.
Locally advanced or metastatic non-small cell lung cancer – This is a type of cancer that starts in the cells of the lung and is not composed of small, round cells. Locally advanced means the cancer has grown into nearby structures or tissues near the lungs. Metastatic means the cancer cells have spread from the original site in the lung to other parts of the body. As the disease progresses, these cells can form new tumors in distant organs. The condition typically involves the uncontrolled growth of abnormal cells within the lung tissue.
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