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Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: Pfizer
Summary
This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC. * Is not a candidate for complete surgical resection or curative chemoradiotherapy. * Do not have known actionable genomic alterations * Be treatment naïve for advanced or metastatic disease Participants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion: * Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor. * Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor. Participants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects. The study will include regular visits for: * Treatment and health checks: while participant continues receiving treatment. * Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1410
Start Date
2026-01-06
Completion Date
2032-08-26
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
PF-08634404
Solution for infusion
Pembrolizumab
Injection for IV use
Chemotherapy Regimen 1
Injection for IV use
Chemotherapy Regimen 2
Injection for IV use
Locations (153)
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Goodyear, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Sansum Clinic
Santa Barbara, California, United States
Sansum Clinic
Solvang, California, United States
Florida Cancer Specialists
Bonita Springs, Florida, United States
Florida Cancer Specialists
Bradenton, Florida, United States
Florida Cancer Specialists
Cape Coral, Florida, United States
Florida Cancer Specialists
Clearwater, Florida, United States
BRCR Global- Coral Springs
Coral Springs, Florida, United States
Florida Cancer Specialists
Daytona Beach, Florida, United States
Florida Cancer Specialists
Fleming Island, Florida, United States
Helios Clinical Research
Fort Lauderdale, Florida, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Gainesville, Florida, United States
Florida Cancer Specialists
Largo, Florida, United States
Florida Cancer Specialists
Lecanto, Florida, United States
Florida Cancer Specialists
N. Venice, Florida, United States
Florida Cancer Specialists
Naples, Florida, United States
Florida Cancer Specialists
Ocala, Florida, United States
Florida Cancer Specialists
Orange City, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Florida Cancer Specialists
Orlando, Florida, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, United States
Florida Cancer Specialists
Palm Beach Gardens, Florida, United States
Florida Cancer Specialists
Port Charlotte, Florida, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Florida Cancer Specialists
Sebring, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists
Tallahassee, Florida, United States
BRCR Global - Tamarac
Tamarac, Florida, United States
Florida Cancer Specialists
Tampa, Florida, United States
Florida Cancer Specialists
Tavares, Florida, United States
Florida Cancer Specialists
The Villages, Florida, United States
Florida Cancer Specialists
Trinity, Florida, United States
Florida Cancer Specialists
Wellington, Florida, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, United States
Florida Cancer Specialists
Winter Park, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Hope and Healing Cancer Services
New Lenox, Illinois, United States
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare, P.C.
Peoria, Illinois, United States
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, United States
Illinois CancerCare-Washington
Washington, Illinois, United States
Maryland Oncology Hematology, P.A.
Annapolis, Maryland, United States
Maryland Oncology Hematology, P.A.
Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A.
Brandywine, Maryland, United States
Maryland Oncology Hematology - Columbia
Columbia, Maryland, United States
Maryland Oncology Hematology, P.A.
Germantown, Maryland, United States
Maryland Oncology Hematology, P.A.
Largo, Maryland, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, United States
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Chaska, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, United States
Nebraska Hematology-Oncology, P.C.
Lincoln, Nebraska, United States
Cancer Partners of Nebraska - April Sampson Cancer Center
Lincoln, Nebraska, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Carolina Cancer Research Center
Wilson, North Carolina, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, United States
Tennessee Cancer Specialists Dowell Springs location
Knoxville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology - West Texas
Abilene, Texas, United States
Texas Oncology - Northeast Texas
Allen, Texas, United States
Texas Oncology - West Texas
Amarillo, Texas, United States
Texas Oncology - Central/South Texas
Austin, Texas, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, United States
Texas Oncology - Northeast Texas
Denison, Texas, United States
Texas Oncology - Northeast Texas
Denton, Texas, United States
Texas Oncology - West Texas
El Paso, Texas, United States
Texas Oncology - West Texas
El Paso, Texas, United States
Texas Oncology - West Texas
El Paso, Texas, United States
Texas Oncology - Northeast Texas
Flower Mound, Texas, United States
Texas Oncology - Central/South Texas
Harlingen, Texas, United States
Texas Oncology - Gulf Coast
Houston, Texas, United States
Texas Oncology - Gulf Coast
Houston, Texas, United States
Texas Oncology - Gulf Coast
Houston, Texas, United States
Texas Oncology - Gulf Coast
Humble, Texas, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States
US Oncology Investigational Products Center
Irving, Texas, United States
Texas Oncology - Northeast Texas
Lewisville, Texas, United States
Texas Oncology - Northeast Texas
Longview, Texas, United States
Texas Oncology - Central/South Texas
McAllen, Texas, United States
Texas Oncology - Northeast Texas
McKinney, Texas, United States
Texas Oncology - West Texas
Midland, Texas, United States
Texas Oncology - West Texas
Odessa, Texas, United States
Texas Oncology - Northeast Texas
Palestine, Texas, United States
Texas Oncology - Northeast Texas
Paris, Texas, United States
Texas Oncology - Gulf Coast
Pearland, Texas, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Texas Oncology - Central/South Texas
Waco, Texas, United States
Texas Oncology - Gulf Coast
Webster, Texas, United States
Texas Oncology - Central/South Texas
Weslaco, Texas, United States
Texas Oncology - West Texas
Wichita Falls, Texas, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States
Minnesota Oncology Hematology, P.A.
Hudson, Wisconsin, United States
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Gympie Hospital
Gympie, Queensland, Australia
Nambour General Hospital
Nambour, Queensland, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, Australia
Yitzhak Shamir Medical Center
Ẕerifin, HA Merkaz, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Gunma Prefectural Cancer Center
Otashi, Gunma, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe Minimally Invasive Cancer Center
Kobe, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, Japan
Mie Chuo Medical Center
Tsu, Mie-ken, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan
National Hospital Organization Beppu Medical Center
Beppu, Oita Prefecture, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
National Hospital Organization Tokyo National Hospital
Kiyose, Tokyo, Japan
National Hospital Organization Yamaguchi Ube Medical Center
Ube, Yamaguchi, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
National Hospital Organization Kochi National Hospital
Kochi, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Japan
National Hospital Organization Okayama Medical Center
Okayama, Japan
Pan American Center for Oncology Trials, LLC- Dorado Office
Dorado, Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico
BRCR Global Puerto Rico - Hato Rey
San Juan, Puerto Rico
Changhua Christian Hospital
Changhua County, Changhua, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan