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
Public ClinicalTrials.gov record NCT07222566. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07222566
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,410 participants
Conditions and interventions
Conditions
Interventions
- PF-08634404 Biological
- Pembrolizumab Biological
- Chemotherapy Regimen 1 Drug
- Chemotherapy Regimen 2 Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 5, 2026
- Primary completion
- Feb 26, 2029
- Completion
- Aug 25, 2032
- Last update posted
- Aug 16, 2026
2026 – 2032
United States locations
- U.S. sites
- 206
- U.S. states
- 21
- U.S. cities
- 158
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pioneer Research Center | Bullhead City | Arizona | 86442 | Recruiting |
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | Recruiting |
| Ironwood Cancer & Research Centers | Gilbert | Arizona | 85297 | Recruiting |
| Ironwood Cancer & Research Centers | Glendale | Arizona | 85306 | Recruiting |
| Ironwood Cancer & Research Centers | Goodyear | Arizona | 85395 | Recruiting |
| Ironwood Cancer & Research Centers | Mesa | Arizona | 85202 | Recruiting |
| Ironwood Cancer & Research Centers | Mesa | Arizona | 85206 | Recruiting |
| Ironwood Cancer & Research Centers | Phoenix | Arizona | 85028 | Recruiting |
| Ironwood Cancer & Research Centers | Scottsdale | Arizona | 85260 | Recruiting |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | Recruiting |
| Highlands Oncology Group | Rogers | Arkansas | 72758 | Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | Recruiting |
| Oncura Health - Anaheim | Anaheim | California | 92805 | Recruiting |
| Memorial Care Orange Coast Medical Center Attn | Fountain Valley | California | 92708 | Recruiting |
| MemorialCare Orange Coast Medical Center | Fountain Valley | California | 92708 | Recruiting |
| OC Blood and Cancer Care | Fountain Valley | California | 92708 | Recruiting |
| Oncura Health - Fountain Valley | Fountain Valley | California | 92708 | Recruiting |
| Oncura Health - Corporate (Central IDS & Regulatory Only) | Glendale | California | 91204 | Recruiting |
| Memorial Care Saddleback Medical Center Attn | Laguna Hills | California | 92653 | Recruiting |
| MemorialCare Saddleback Medical Center | Laguna Hills | California | 92653 | Recruiting |
| Stockton Hematology Oncology Medical Group | Lodi | California | 95242 | Recruiting |
| Memorial Care Long Beach Medical Center | Long Beach | California | 90806 | Recruiting |
| Oncura Health - Good Samaritan | Los Angeles | California | 90017 | Recruiting |
| California Research Institute | Los Angeles | California | 90027 | Not yet recruiting |
| Stockton Hematology Oncology Medical Group | Manteca | California | 95336 | Recruiting |
| Stockton Hematology Oncology Medical Group | Modesto | California | 95350 | Recruiting |
| Oncura Health - Riverside | Riverside | California | 92501 | Recruiting |
| Sansum Clinic | Santa Barbara | California | 93105 | Recruiting |
| Sansum Clinic | Solvang | California | 93463 | Recruiting |
| Stockton Hematology Oncology Group | Stockton | California | 95204 | Recruiting |
| Stockton Hematology Oncology Medical Group | Tracy | California | 95377 | Recruiting |
| Oncura Health - Valley Presbyterian | Van Nuys | California | 91405 | Recruiting |
| Florida Cancer Specialists | Bonita Springs | Florida | 34135 | Recruiting |
| Florida Cancer Specialists | Bradenton | Florida | 34211 | Recruiting |
| Florida Cancer Specialists | Cape Coral | Florida | 33909 | Recruiting |
| Florida Cancer Specialists | Clearwater | Florida | 33761 | Recruiting |
| BRCR Global- Coral Springs | Coral Springs | Florida | 33065 | Recruiting |
| Florida Cancer Specialists | Daytona Beach | Florida | 32117 | Recruiting |
| Cancer Specialists of North Florida | Fleming Island | Florida | 32003 | Recruiting |
| Florida Cancer Specialists | Fleming Island | Florida | 32003 | Recruiting |
| Helios Clinical Research | Fort Lauderdale | Florida | 33316 | Recruiting |
| Florida Cancer Specialists - South | Fort Myers | Florida | 33901 | Recruiting |
| Florida Cancer Specialists | Fort Myers | Florida | 33905 | Recruiting |
| Florida Cancer Specialists | Fort Myers | Florida | 33908 | Recruiting |
| Florida Cancer Specialists | Gainesville | Florida | 32605 | Recruiting |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32204 | Recruiting |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32218 | Recruiting |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | Recruiting |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32258 | Recruiting |
| Florida Cancer Specialists | Largo | Florida | 33770 | Recruiting |
| Florida Cancer Specialists | Lecanto | Florida | 34461 | Recruiting |
| Florida Cancer Specialists | N. Venice | Florida | 34275 | Recruiting |
| Florida Cancer Specialists | Naples | Florida | 34102 | Recruiting |
| Cancer Specialists of North Florida | Neptune Beach | Florida | 32266 | Recruiting |
| Florida Cancer Specialists | Ocala | Florida | 34474 | Recruiting |
| Alpha Clinical Research Centers LLC | Orange City | Florida | 32763 | Recruiting |
| Florida Cancer Specialists | Orange City | Florida | 32763 | Recruiting |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | Recruiting |
| Florida Cancer Specialists | Orlando | Florida | 32806 | Recruiting |
| Orlando Health Ambulatory Care Center | Orlando | Florida | 32806 | Recruiting |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | Recruiting |
| Orlando Health Orlando Regional Medical Center | Orlando | Florida | 32806 | Recruiting |
| Cancer Care Centers of Brevard, Inc. | Palm Bay | Florida | 32901 | Recruiting |
| Florida Cancer Specialists | Palm Beach Gardens | Florida | 33410 | Recruiting |
| Florida Cancer Specialists | Port Charlotte | Florida | 33980 | Recruiting |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | Recruiting |
| Cancer Specialists of North Florida | Saint Augustine | Florida | 32086 | Recruiting |
| Florida Cancer Specialists | Sarasota | Florida | 34236 | Recruiting |
| Florida Cancer Specialists | Sebring | Florida | 33870 | Recruiting |
| Florida Cancer Specialists | St. Petersburg | Florida | 33701 | Recruiting |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | Recruiting |
| Florida Cancer Specialists | Tallahassee | Florida | 32308 | Recruiting |
| BRCR Medical Center Inc. | Tamarac | Florida | 33321 | Recruiting |
| Florida Cancer Specialists | Tampa | Florida | 33607 | Recruiting |
| Florida Cancer Specialists | Tavares | Florida | 32778 | Recruiting |
| Florida Cancer Specialists | The Villages | Florida | 32159 | Recruiting |
| Florida Cancer Specialists | Trinity | Florida | 34655 | Recruiting |
| Florida Cancer Specialists | Wellington | Florida | 33414 | Recruiting |
| Florida Cancer Specialists - East | West Palm Beach | Florida | 33401 | Recruiting |
| Florida Cancer Specialists | Winter Park | Florida | 32789 | Recruiting |
| Illinois CancerCare - Bloomington | Bloomington | Illinois | 61704 | Recruiting |
| University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center) | Chicago | Illinois | 60612 | Recruiting |
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612 | Recruiting |
| Illinois Cancer Specialists | Chicago | Illinois | 60631 | Recruiting |
| Illinois CancerCare - Galesburg | Galesburg | Illinois | 61401 | Recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | 60521 | Recruiting |
| Hope and Healing Cancer Services | New Lenox | Illinois | 60451 | Recruiting |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | Recruiting |
| Illinois CancerCare-Ottawa-Fox River Cancer Center | Ottawa | Illinois | 61350 | Recruiting |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | Recruiting |
| Illinois CancerCare, P.C. | Peoria | Illinois | 61615 | Recruiting |
| Illinois CancerCare-Peru - Valley Regional Cancer Center | Peru | Illinois | 61354 | Recruiting |
| Illinois CancerCare-Washington | Washington | Illinois | 61571 | Recruiting |
| Community Health Network, Inc | Indianapolis | Indiana | 46219 | Not yet recruiting |
| Community Health Network, Inc. | Indianapolis | Indiana | 46227 | Not yet recruiting |
| Community Health Network, Inc. | Indianapolis | Indiana | 46250 | Not yet recruiting |
| Pontchartrain Cancer Center | Covington | Louisiana | 70433 | Recruiting |
| Pontchartrain Cancer Center | Hammond | Louisiana | 70403 | Recruiting |
| Maryland Oncology Hematology, P.A. | Annapolis | Maryland | 21401 | Recruiting |
| Maryland Oncology Hematology, P.A. | Bethesda | Maryland | 20817 | Recruiting |
| Maryland Oncology Hematology, P.A. | Brandywine | Maryland | 20613 | Recruiting |
| Maryland Oncology Hematology - Columbia | Columbia | Maryland | 21044 | Recruiting |
| Maryland Oncology Hematology, P.A. | Germantown | Maryland | 20876 | Recruiting |
| Maryland Oncology Hematology, P.A. | Largo | Maryland | 20774 | Recruiting |
| Maryland Oncology Hematology, P.A. | Rockville | Maryland | 20850 | Recruiting |
| Maryland Oncology Hematology, P.A. | Silver Spring | Maryland | 20904 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Burnsville | Minnesota | 55337 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Chaska | Minnesota | 55318 | Recruiting |
| Allina Health Cancer Institute - Mercy Hospital | Coon Rapids | Minnesota | 55433 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Coon Rapids | Minnesota | 55433 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Edina | Minnesota | 55435 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Maple Grove | Minnesota | 55369 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Maplewood | Minnesota | 55109 | Recruiting |
| Allina Health Cancer Institute - Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | Recruiting |
| Allina Health Cancer Institute - United Hospital | Saint Paul | Minnesota | 55102 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Woodbury | Minnesota | 55125 | Recruiting |
| Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi | 39401 | Recruiting |
| NHO Revive Research Institute, LLC | Lincoln | Nebraska | 68506 | Recruiting |
| NHO Support Center | Lincoln | Nebraska | 68506 | Recruiting |
| Cancer Partners of Nebraska | Lincoln | Nebraska | 68516 | Recruiting |
| New York Oncology Hematology | Albany | New York | 12206 | Recruiting |
| New York Oncology Hematology | Clifton Park | New York | 12065 | Recruiting |
| Hematology Oncology Associates of Rockland | Nyack | New York | 10960 | Recruiting |
| FirstHealth Cancer Center | Pinehurst | North Carolina | 28374 | Recruiting |
| FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | 28374 | Recruiting |
| Carolina Cancer Research Center | Wilson | North Carolina | 27893 | Recruiting |
| Aultman Hospital | Canton | Ohio | 44710 | Recruiting |
| Aultman Medical Group Hematology and Oncology | Canton | Ohio | 44710 | Recruiting |
| Oncology Hematology Care Clinical Trials | Cincinnati | Ohio | 45211 | Recruiting |
| Oncology Hematology Care Clinical Trials | Cincinnati | Ohio | 45242 | Recruiting |
| Oncology Hematology Care Clinical Trials | Cincinnati | Ohio | 45245 | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Recruiting |
| Oncology Hematology Care Clinical Trials | Fairfield | Ohio | 45014 | Recruiting |
| Aultman Massillon | Massillon | Ohio | 44646 | Recruiting |
| Aultman North | North Canton | Ohio | 44720 | Recruiting |
| Aultman Orrville Hospital | Orrville | Ohio | 44667 | Recruiting |
| Northwest Cancer Specialists, P.C | Happy Valley | Oregon | 97015 | Recruiting |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | Recruiting |
| Northwest Cancer Specialists, P.C | Tigard | Oregon | 97223 | Recruiting |
| Tennessee Oncology, PLLC - Chattanooga Downtown | Chattanooga | Tennessee | 37403 | Recruiting |
| Tennessee Oncology, PLLC - Chattanooga - Medical Park II | Chattanooga | Tennessee | 37404 | Recruiting |
| Tennessee Oncology, PLLC - Franklin | Franklin | Tennessee | 37067 | Recruiting |
| Tennessee Oncology, PLLC - Gallatin | Gallatin | Tennessee | 37066 | Recruiting |
| Tennessee Cancer Specialists Dowell Springs location | Knoxville | Tennessee | 37909 | Recruiting |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | Recruiting |
| Tennessee Cancer Specialists - Parkwest Location | Knoxville | Tennessee | 37932 | Recruiting |
| Tennessee Oncology, PLLC - Lebanon | Lebanon | Tennessee | 37090 | Recruiting |
| Tennesseee Oncology, PLLC - Mount Juliet | Mount Juliet | Tennessee | 37122 | Recruiting |
| Tennessee Oncology, PLLC - Murfreesboro | Murfreesboro | Tennessee | 37129 | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology | Nashville | Tennessee | 37203 | Recruiting |
| Tennessee Oncology, PLLC - Saint Thomas West | Nashville | Tennessee | 37205 | Recruiting |
| Tennessee Oncology, PLLC -Shelbyville | Shelbyville | Tennessee | 37160 | Recruiting |
| Texas Oncology - West Texas | Abilene | Texas | 79606 | Recruiting |
| Texas Oncology - Northeast Texas | Allen | Texas | 75013 | Recruiting |
| Texas Oncology - West Texas | Amarillo | Texas | 79124 | Recruiting |
| Texas Oncology - DFW | Arlington | Texas | 76012 | Recruiting |
| Texas Oncology - DFW | Arlington | Texas | 76014 | Recruiting |
| Texas Oncology - Central/South Texas | Austin | Texas | 78758 | Recruiting |
| Texas Oncology - Gulf Coast | Beaumont | Texas | 77702 | Recruiting |
| Texas Oncology - DFW | Bedford | Texas | 76022 | Recruiting |
| Texas Oncology - DFW | Dallas | Texas | 75203 | Recruiting |
| Texas Oncology - DFW | Dallas | Texas | 75230 | Recruiting |
| Texas Oncology - DFW | Dallas | Texas | 75231 | Recruiting |
| Texas Oncology - DFW | Dallas | Texas | 75237 | Recruiting |
| Texas Oncology - DFW | Dallas | Texas | 75246 | Recruiting |
| Texas Oncology - Northeast Texas | Denison | Texas | 75020 | Recruiting |
| Texas Oncology - Northeast Texas | Denton | Texas | 76201 | Recruiting |
| Texas Oncology - West Texas | El Paso | Texas | 79902 | Recruiting |
| Texas Oncology - West Texas | El Paso | Texas | 79915 | Recruiting |
| Texas Oncology - West Texas | El Paso | Texas | 79938 | Recruiting |
| Texas Oncology - Northeast Texas | Flower Mound | Texas | 75028 | Recruiting |
| Texas Oncology - DFW | Fort Worth | Texas | 76104 | Recruiting |
| Texas Oncology - DFW | Grapevine | Texas | 76051 | Recruiting |
| Texas Oncology - Central/South Texas | Harlingen | Texas | 78550 | Recruiting |
| Texas Oncology - Gulf Coast | Houston | Texas | 77024 | Recruiting |
| Texas Oncology - Gulf Coast | Houston | Texas | 77054 | Recruiting |
| Texas Oncology - Gulf Coast | Houston | Texas | 77070 | Recruiting |
| Texas Oncology - Gulf Coast | Humble | Texas | 77338 | Recruiting |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | Recruiting |
| US Oncology Investigational Products Center | Irving | Texas | 75063 | Recruiting |
| Texas Oncology - Northeast Texas | Lewisville | Texas | 75056 | Recruiting |
| Texas Oncology - Northeast Texas | Longview | Texas | 75601 | Recruiting |
| Texas Oncology - Central/South Texas | McAllen | Texas | 78503 | Recruiting |
| Texas Oncology - Northeast Texas | McKinney | Texas | 75071 | Recruiting |
| Texas Oncology - West Texas | Midland | Texas | 79701 | Recruiting |
| Texas Oncology - West Texas | Odessa | Texas | 79761 | Recruiting |
| Texas Oncology - Northeast Texas | Palestine | Texas | 75801 | Recruiting |
| Texas Oncology - Northeast Texas | Paris | Texas | 75460 | Recruiting |
| Texas Oncology - Gulf Coast | Pearland | Texas | 77584 | Recruiting |
| Texas Oncology - DFW | Plano | Texas | 75075 | Recruiting |
| Texas Oncology - DFW | Plano | Texas | 75093 | Recruiting |
| Texas Oncology - Gulf Coast | Sugar Land | Texas | 77479 | Recruiting |
| Texas Oncology - Gulf Coast | The Woodlands | Texas | 77380 | Recruiting |
| Texas Oncology - Northeast Texas | Tyler | Texas | 75702 | Recruiting |
| Texas Oncology - Central/South Texas | Waco | Texas | 76712 | Recruiting |
| Texas Oncology - Gulf Coast | Webster | Texas | 77598 | Recruiting |
| Texas Oncology - Central/South Texas | Weslaco | Texas | 78596 | Recruiting |
| Texas Oncology - West Texas | Wichita Falls | Texas | 76310 | Recruiting |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | Recruiting |
| UVA Comprehensive Cancer Center | Charlottesville | Virginia | 22903 | Recruiting |
| UVA Health Fontaine Research Park | Charlottesville | Virginia | 22903 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22908 | Recruiting |
| UVA Health Cancer Care Pantops | Charlottesville | Virginia | 22911 | Recruiting |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | Recruiting |
| Minnesota Oncology Hematology, P.A. | Hudson | Wisconsin | 54016 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 234 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07222566, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 16, 2026 · Synced Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07222566 live on ClinicalTrials.gov.