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

Purpose

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.

Conditions

  • Advanced Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Non-Small-Cell Lung (NSCLC)
  • Metastatic Non Small Cell Lung Cancer
  • Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 years of age or older at screening. - Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system). - Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy - PD-L1 status available based on local testing results - Measurable disease based on RECIST v1.1 per investigator. - Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1 - Expected survival ≥12 weeks

Exclusion Criteria

  • Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology. - Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter < 1 cm are permitted. - Participants with clinically significant risk of hemorrhage or fistula are excluded. - Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. - Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1. - Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody. - History of allogeneic organ / hematopoietic stem cell transplantation. - Participants with any of the following respiratory conditions: - Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis - Grade ≥3 pulmonary disease unrelated to underlying malignancy - History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events. - Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention. - History of severe bleeding tendency or coagulation dysfunction - History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose. - Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV). - Participants with history of immunodeficiency - Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study. - Previous systemic anti-tumor therapy including: 1. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC. 2. Previous treatment with immunotherapy 3. Prior radiotherapy > 30 Gy to the lung < 6 months of first dose of study intervention 4. Palliative local therapy < 2 weeks before the first dose of study intervention; 5. Non-specific immunomodulatory therapy < 2 weeks before the first dose. 6. Prior systemic anti-angiogenic therapy - Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy. - Prior and concomitant therapy: 1. therapeutic oral or parenteral anticoagulants or thrombolytic agents < 10 days to the first dose. 2. chronic antiplatelet therapy <7 days to randomization. 3. live or attenuated live vaccine < 4 weeks to the first dose. 4. current high-dose systemic corticosteroids. 5. prohibited concomitant medication(s) < 21 days to the first dose. - Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
This is double-blind study, neither the participants nor the study team will know whether the participants are receiving PF-08634404 or Pembrolizumab.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
Participants will receive PF-08634404 combined with chemotherapy regimen 1, followed by maintenance therapy with PF-08634404.
  • Biological: PF-08634404
    Solution for infusion
  • Drug: Chemotherapy Regimen 1
    Injection for IV use
Active Comparator
Arm B
Participants will receive pembrolizumab combined with chemotherapy regimen 1, followed by maintenance therapy with pembrolizumab.
  • Biological: Pembrolizumab
    Injection for IV use
  • Drug: Chemotherapy Regimen 1
    Injection for IV use
Experimental
Arm C
Participants will receive PF-08634404 combined with chemotherapy regimen 2, followed by maintenance therapy with PF-08634404 and chemotherapy.
  • Biological: PF-08634404
    Solution for infusion
  • Drug: Chemotherapy Regimen 2
    Injection for IV use
Active Comparator
Arm D
Participants will receive pembrolizumab combined with chemotherapy regimen 2, followed by maintenance therapy with pembrolizumab and chemotherapy.
  • Biological: Pembrolizumab
    Injection for IV use
  • Drug: Chemotherapy Regimen 2
    Injection for IV use

Recruiting Locations

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

Oncura Health - Anaheim
Anaheim, California 92805

Memorial Care Orange Coast Medical Center Attn
Fountain Valley, California 92708

MemorialCare Orange Coast Medical Center
Fountain Valley, California 92708

OC Blood and Cancer Care
Fountain Valley, California 92708

Oncura Health - Fountain Valley
Fountain Valley, California 92708

Oncura Health - Corporate (Central IDS & Regulatory Only)
Glendale, California 91204

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

Oncura Health - Good Samaritan
Los Angeles, California 90017

Stockton Hematology Oncology Medical Group
Manteca, California 95336

Stockton Hematology Oncology Medical Group
Modesto, California 95350

Oncura Health - 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

Oncura Health - 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

Alpha Clinical Research Centers LLC
Orange City, Florida 32763

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

Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi 39401

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

FirstHealth Cancer Center
Pinehurst, North Carolina 28374

FirstHealth Moore Regional Hospital
Pinehurst, North Carolina 28374

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

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

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

University of Tennessee Medical Center
Knoxville, Tennessee 37920

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

Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112

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

Pan American Center for Oncology Trials, LLC- Dorado Office
Dorado, Puerto Rico 00646

Pan American Center for Oncology Trials, LLC - Manati Office
Manati, Puerto Rico 00674

Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez, Puerto Rico 00680

BRCR Global Puerto Rico - Hato Rey
San Juan, Puerto Rico 00917

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com