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
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.
Arms & interventions
- BiologicalPF-08634404
Solution for infusion
- BiologicalPembrolizumab
Injection for IV use
- DrugChemotherapy Regimen 1
Injection for IV use
- DrugChemotherapy Regimen 2
Injection for IV use
Outcome measures
Primary
Overall Survival
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Approximately 39 months
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST v1.1, or death due to any cause, whichever occurs first.
Time frame: Approximately 32 months
Secondary
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by BICR
Time frame: Approximately 32 months
Progression Free Survival as assessed by Investigator
Time frame: Approximately 32 months
Confirmed ORR using RECIST v1.1 as assessed by investigator
Time frame: Approximately 32 months
Duration of Response (DoR) as assessed by BICR
Time frame: Approximately 32 months
Duration of Response (DoR) as assessed by Investigator
Time frame: Approximately 32 months
Number of Participants With Adverse Events (AEs)
Time frame: Through end of study and up to approximately 39 months
Number of Participants With Clinical Laboratory Abnormalities
Time frame: through end of study and up to approximately 39 months
Pharmacokinetics (PK): Serum concentrations of PF-08634404
Time frame: Through end of study and up to approximately 39 months
Incidence of Anti-Drug Antibody (ADA) against PF-08634404.
Time frame: Through end of study and up to approximately 39 months
Mean scores and Change from baseline in the global health status/quality of life (QoL) and physical function scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Approximately 39 months
Time to definitive deterioration (TTdD) in in the global health status/QoL and physical function scores on the EORTC QLQ-C30
Time frame: Approximately 39 months
Mean scores and Change from Baseline in dyspnea, cough, and chest pain scores on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 QLQ-LC13
Time frame: Approximately 39 months
TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
Time frame: Approximately 39 months
Eligibility criteria
Study locations (184)
Pioneer Research Center
Bullhead City, Arizona, 86442
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
Ironwood Cancer & Research Centers
Gilbert, Arizona, 85297
Ironwood Cancer & Research Centers
Glendale, Arizona, 85306
Ironwood Cancer & Research Centers
Goodyear, Arizona, 85395
Ironwood Cancer & Research Centers
Mesa, Arizona, 85202
Ironwood Cancer & Research Centers
Mesa, Arizona, 85206
Ironwood Cancer & Research Centers
Phoenix, Arizona, 85028
Ironwood Cancer & Research Centers
Scottsdale, Arizona, 85260
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Highlands Oncology Group
Rogers, Arkansas, 72758
Highlands Oncology Group
Springdale, Arkansas, 72762
Los Angeles Cancer Network - Anaheim
Anaheim, California, 92805
Los Angeles Cancer Network - Fountain Valley
Fountain Valley, California, 92708
Memorial Care Orange Coast Medical Center Attn
Fountain Valley, California, 92708
OC Blood and Cancer Care
Fountain Valley, California, 92708
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708
Memorial Care Saddleback Medical Center Attn
Laguna Hills, California, 92653
Stockton Hematology Oncology Medical Group
Lodi, California, 95242
Memorial Care Long Beach Medical Center
Long Beach, California, 90806
Los Angeles Cancer Network - Good Samaritan
Los Angeles, California, 90017
Stockton Hematology Oncology Medical Group
Manteca, California, 95336
Stockton Hematology Oncology Medical Group
Modesto, California, 95350
Los Angeles Cancer Network - Riverside
Riverside, California, 92501
Sansum Clinic
Santa Barbara, California, 93105
Sansum Clinic
Solvang, California, 93463
Stockton Hematology Oncology Group
Stockton, California, 95204
Stockton Hematology Oncology Medical Group
Tracy, California, 95377
Los Angeles Cancer Network - Valley Presbyterian
Van Nuys, California, 91405
Florida Cancer Specialists
Bonita Springs, Florida, 34135
Florida Cancer Specialists
Bradenton, Florida, 34211
Florida Cancer Specialists
Cape Coral, Florida, 33909
Florida Cancer Specialists
Clearwater, Florida, 33761
BRCR Global- Coral Springs
Coral Springs, Florida, 33065
Florida Cancer Specialists
Daytona Beach, Florida, 32117
Cancer Specialists of North Florida
Fleming Island, Florida, 32003
Florida Cancer Specialists
Fleming Island, Florida, 32003
Helios Clinical Research
Fort Lauderdale, Florida, 33316
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
Florida Cancer Specialists
Fort Myers, Florida, 33905
Florida Cancer Specialists
Fort Myers, Florida, 33908
Florida Cancer Specialists
Gainesville, Florida, 32605
Cancer Specialists of North Florida
Jacksonville, Florida, 32204
Cancer Specialists of North Florida
Jacksonville, Florida, 32218
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Cancer Specialists of North Florida
Jacksonville, Florida, 32258
Florida Cancer Specialists
Largo, Florida, 33770
Florida Cancer Specialists
Lecanto, Florida, 34461
Florida Cancer Specialists
N. Venice, Florida, 34275
Florida Cancer Specialists
Naples, Florida, 34102
Cancer Specialists of North Florida
Neptune Beach, Florida, 32266
Florida Cancer Specialists
Ocala, Florida, 34474
Florida Cancer Specialists
Orange City, Florida, 32763
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Florida Cancer Specialists
Orlando, Florida, 32806
Orlando Health Ambulatory Care Center
Orlando, Florida, 32806
Orlando Health Cancer Institute
Orlando, Florida, 32806
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901
Florida Cancer Specialists
Palm Beach Gardens, Florida, 33410
Florida Cancer Specialists
Port Charlotte, Florida, 33980
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Cancer Specialists of North Florida
Saint Augustine, Florida, 32086
Florida Cancer Specialists
Sarasota, Florida, 34236
Florida Cancer Specialists
Sebring, Florida, 33870
Florida Cancer Specialists
St. Petersburg, Florida, 33701
Florida Cancer Specialists
St. Petersburg, Florida, 33705
Florida Cancer Specialists
Tallahassee, Florida, 32308
BRCR Medical Center Inc.
Tamarac, Florida, 33321
Florida Cancer Specialists
Tampa, Florida, 33607
Florida Cancer Specialists
Tavares, Florida, 32778
Florida Cancer Specialists
The Villages, Florida, 32159
Florida Cancer Specialists
Trinity, Florida, 34655
Florida Cancer Specialists
Wellington, Florida, 33414
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401
Florida Cancer Specialists
Winter Park, Florida, 32789
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61704
University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)
Chicago, Illinois, 60612
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612
Illinois CancerCare - Galesburg
Galesburg, Illinois, 61401
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Hope and Healing Cancer Services
New Lenox, Illinois, 60451
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare, P.C.
Peoria, Illinois, 61615
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, 61354
Illinois CancerCare-Washington
Washington, Illinois, 61571
Pontchartrain Cancer Center
Covington, Louisiana, 70433
Pontchartrain Cancer Center
Hammond, Louisiana, 70403
Maryland Oncology Hematology, P.A.
Annapolis, Maryland, 21401
Maryland Oncology Hematology, P.A.
Bethesda, Maryland, 20817
Maryland Oncology Hematology, P.A.
Brandywine, Maryland, 20613
Maryland Oncology Hematology - Columbia
Columbia, Maryland, 21044
Maryland Oncology Hematology, P.A.
Germantown, Maryland, 20876
Maryland Oncology Hematology, P.A.
Largo, Maryland, 20774
Maryland Oncology Hematology, P.A.
Rockville, Maryland, 20850
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, 55337
Minnesota Oncology Hematology, P.A.
Chaska, Minnesota, 55318
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, 55109
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, 55125
NHO Revive Research Institute, LLC
Lincoln, Nebraska, 68506
NHO Support Center
Lincoln, Nebraska, 68506
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516
New York Oncology Hematology
Albany, New York, 12206
New York Oncology Hematology
Clifton Park, New York, 12065
Hematology Oncology Associates of Rockland
Nyack, New York, 10960
Carolina Cancer Research Center
Wilson, North Carolina, 27893
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45211
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45242
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45245
Oncology Hematology Care Clinical Trials
Fairfield, Ohio, 45014
Northwest Cancer Specialists, P.C
Happy Valley, Oregon, 97015
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227
Northwest Cancer Specialists, P.C
Tigard, Oregon, 97223
Tennessee Oncology, PLLC - Chattanooga Downtown
Chattanooga, Tennessee, 37403
Tennessee Oncology, PLLC - Chattanooga - Medical Park II
Chattanooga, Tennessee, 37404
Tennessee Oncology, PLLC - Franklin
Franklin, Tennessee, 37067
Tennessee Oncology, PLLC - Gallatin
Gallatin, Tennessee, 37066
Tennessee Cancer Specialists Dowell Springs location
Knoxville, Tennessee, 37909
Tennessee Cancer Specialists - Parkwest Location
Knoxville, Tennessee, 37932
Tennessee Oncology, PLLC - Lebanon
Lebanon, Tennessee, 37090
Tennesseee Oncology, PLLC - Mount Juliet
Mount Juliet, Tennessee, 37122
Tennessee Oncology, PLLC - Murfreesboro
Murfreesboro, Tennessee, 37129
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC - Saint Thomas West
Nashville, Tennessee, 37205
Tennessee Oncology, PLLC -Shelbyville
Shelbyville, Tennessee, 37160
Texas Oncology - West Texas
Abilene, Texas, 79606
Texas Oncology - Northeast Texas
Allen, Texas, 75013
Texas Oncology - West Texas
Amarillo, Texas, 79124
Texas Oncology - DFW
Arlington, Texas, 76012
Texas Oncology - DFW
Arlington, Texas, 76014
Texas Oncology - Central/South Texas
Austin, Texas, 78758
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702
Texas Oncology - DFW
Bedford, Texas, 76022
Texas Oncology - DFW
Dallas, Texas, 75203
Texas Oncology - DFW
Dallas, Texas, 75230
Texas Oncology - DFW
Dallas, Texas, 75231
Texas Oncology - DFW
Dallas, Texas, 75237
Texas Oncology - DFW
Dallas, Texas, 75246
Texas Oncology - Northeast Texas
Denison, Texas, 75020
Texas Oncology - Northeast Texas
Denton, Texas, 76201
Texas Oncology - West Texas
El Paso, Texas, 79902
Texas Oncology - West Texas
El Paso, Texas, 79915
Texas Oncology - West Texas
El Paso, Texas, 79938
Texas Oncology - Northeast Texas
Flower Mound, Texas, 75028
Texas Oncology - DFW
Fort Worth, Texas, 76104
Texas Oncology - DFW
Grapevine, Texas, 76051
Texas Oncology - Central/South Texas
Harlingen, Texas, 78550
Texas Oncology - Gulf Coast
Houston, Texas, 77024
Texas Oncology - Gulf Coast
Houston, Texas, 77054
Texas Oncology - Gulf Coast
Houston, Texas, 77070
Texas Oncology - Gulf Coast
Humble, Texas, 77338
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063
US Oncology Investigational Products Center
Irving, Texas, 75063
Texas Oncology - Northeast Texas
Lewisville, Texas, 75056
Texas Oncology - Northeast Texas
Longview, Texas, 75601
Texas Oncology - Central/South Texas
McAllen, Texas, 78503
Texas Oncology - Northeast Texas
McKinney, Texas, 75071
Texas Oncology - West Texas
Midland, Texas, 79701
Texas Oncology - West Texas
Odessa, Texas, 79761
Texas Oncology - Northeast Texas
Palestine, Texas, 75801
Texas Oncology - Northeast Texas
Paris, Texas, 75460
Texas Oncology - Gulf Coast
Pearland, Texas, 77584
Texas Oncology - DFW
Plano, Texas, 75075
Texas Oncology - DFW
Plano, Texas, 75093
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Texas Oncology - Central/South Texas
Waco, Texas, 76712
Texas Oncology - Gulf Coast
Webster, Texas, 77598
Texas Oncology - Central/South Texas
Weslaco, Texas, 78596
Texas Oncology - West Texas
Wichita Falls, Texas, 76310
UVA Comprehensive Cancer Center
Charlottesville, Virginia, 22903
UVA Health Fontaine Research Park
Charlottesville, Virginia, 22903
University of Virginia
Charlottesville, Virginia, 22908
UVA Health Cancer Care Pantops
Charlottesville, Virginia, 22911
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Minnesota Oncology Hematology, P.A.
Hudson, Wisconsin, 54016