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
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
3 other identifiers
interventional
1,410
14 countries
229
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2026
Longer than P75 for phase_3
229 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2025
CompletedFirst Posted
Study publicly available on registry
October 30, 2025
CompletedStudy Start
First participant enrolled
January 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 26, 2032
April 20, 2026
April 1, 2026
3.1 years
October 28, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
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.
Approximately 32 months
Secondary Outcomes (13)
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by BICR
Approximately 32 months
Progression Free Survival as assessed by Investigator
Approximately 32 months
Confirmed ORR using RECIST v1.1 as assessed by investigator
Approximately 32 months
Duration of Response (DoR) as assessed by BICR
Approximately 32 months
Duration of Response (DoR) as assessed by Investigator
Approximately 32 months
- +8 more secondary outcomes
Study Arms (4)
Arm A
EXPERIMENTALParticipants will receive PF-08634404 combined with chemotherapy regimen 1, followed by maintenance therapy with PF-08634404.
Arm B
ACTIVE COMPARATORParticipants will receive pembrolizumab combined with chemotherapy regimen 1, followed by maintenance therapy with pembrolizumab.
Arm C
EXPERIMENTALParticipants will receive PF-08634404 combined with chemotherapy regimen 2, followed by maintenance therapy with PF-08634404 and chemotherapy.
Arm D
ACTIVE COMPARATORParticipants will receive pembrolizumab combined with chemotherapy regimen 2, followed by maintenance therapy with pembrolizumab and chemotherapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (229)
Pioneer Research Center
Bullhead City, Arizona, 86442, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, 85297, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, 85306, United States
Ironwood Cancer & Research Centers
Goodyear, Arizona, 85395, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, 85202, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, 85206, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, 85028, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, 85260, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group
Rogers, Arkansas, 72758, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Los Angeles Cancer Network - Anaheim
Anaheim, California, 92805, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, 92703, United States
Los Angeles Cancer Network - Fountain Valley
Fountain Valley, California, 92708, United States
Memorial Care Orange Coast Medical Center Attn
Fountain Valley, California, 92708, United States
OC Blood and Cancer Care
Fountain Valley, California, 92708, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708, United States
Memorial Care Saddleback Medical Center Attn
Laguna Hills, California, 92653, United States
Memorial Care Long Beach Medical Center
Long Beach, California, 90806, United States
Los Angeles Cancer Network - Good Samaritan
Los Angeles, California, 90017, United States
Los Angeles Cancer Network - Riverside
Riverside, California, 92501, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Sansum Clinic
Solvang, California, 93463, United States
Los Angeles Cancer Network - Valley Presbyterian
Van Nuys, California, 91405, United States
Florida Cancer Specialists
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Bradenton, Florida, 34211, United States
Florida Cancer Specialists
Cape Coral, Florida, 33909, United States
Florida Cancer Specialists
Clearwater, Florida, 33761, United States
BRCR Global- Coral Springs
Coral Springs, Florida, 33065, United States
Florida Cancer Specialists
Daytona Beach, Florida, 32117, United States
Florida Cancer Specialists
Fleming Island, Florida, 32003, United States
Helios Clinical Research
Fort Lauderdale, Florida, 33316, United States
Florida Cancer Specialists - South
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists
Fort Myers, Florida, 33908, United States
Florida Cancer Specialists
Gainesville, Florida, 32605, United States
Florida Cancer Specialists
Largo, Florida, 33770, United States
Florida Cancer Specialists
Lecanto, Florida, 34461, United States
Florida Cancer Specialists
N. Venice, Florida, 34275, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Florida Cancer Specialists
Ocala, Florida, 34474, United States
Florida Cancer Specialists
Orange City, Florida, 32763, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
Florida Cancer Specialists
Orlando, Florida, 32806, United States
Orlando Health Ambulatory Care Center
Orlando, Florida, 32806, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901, United States
Florida Cancer Specialists
Palm Beach Gardens, Florida, 33410, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Florida Cancer Specialists
Sebring, Florida, 33870, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33701, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists
Tallahassee, Florida, 32308, United States
BRCR Global - Tamarac
Tamarac, Florida, 33321, United States
Florida Cancer Specialists
Tampa, Florida, 33607, United States
Florida Cancer Specialists
Tavares, Florida, 32778, United States
Florida Cancer Specialists
The Villages, Florida, 32159, United States
Florida Cancer Specialists
Trinity, Florida, 34655, United States
Florida Cancer Specialists
Wellington, Florida, 33414, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, 33401, United States
Florida Cancer Specialists
Winter Park, Florida, 32789, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, 61401, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Hope and Healing Cancer Services
New Lenox, Illinois, 60451, United States
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare, P.C.
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, 61354, United States
Illinois CancerCare-Washington
Washington, Illinois, 61571, United States
Maryland Oncology Hematology, P.A.
Annapolis, Maryland, 21401, United States
Maryland Oncology Hematology, P.A.
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology, P.A.
Brandywine, Maryland, 20613, United States
Maryland Oncology Hematology - Columbia
Columbia, Maryland, 21044, United States
Maryland Oncology Hematology, P.A.
Germantown, Maryland, 20876, United States
Maryland Oncology Hematology, P.A.
Largo, Maryland, 20774, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, 20850, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904, United States
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, 55337, United States
Minnesota Oncology Hematology, P.A.
Chaska, Minnesota, 55318, United States
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, 55125, United States
NHO Revive Research Institute, LLC
Lincoln, Nebraska, 68506, United States
Cancer Partners of Nebraska - April Sampson Cancer Center
Lincoln, Nebraska, 68516, United States
New York Oncology Hematology
Albany, New York, 12206, United States
New York Oncology Hematology
Clifton Park, New York, 12065, United States
Hematology Oncology Associates of Rockland
Nyack, New York, 10960, United States
Carolina Cancer Research Center
Wilson, North Carolina, 27893, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45211, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45242, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, 45245, United States
Oncology Hematology Care Clinical Trials
Fairfield, Ohio, 45014, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223, United States
Tennessee Oncology, PLLC - Chattanooga Downtown
Chattanooga, Tennessee, 37403, United States
Tennessee Oncology, PLLC - Chattanooga - Medical Park II
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Franklin
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC - Gallatin
Gallatin, Tennessee, 37066, United States
Tennessee Cancer Specialists Dowell Springs location
Knoxville, Tennessee, 37909, United States
Tennessee Oncology, PLLC - Lebanon
Lebanon, Tennessee, 37090, United States
Tennesseee Oncology, PLLC - Mount Juliet
Mount Juliet, Tennessee, 37122, United States
Tennessee Oncology, PLLC - Murfreesboro
Murfreesboro, Tennessee, 37129, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Saint Thomas West
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC -Shelbyville
Shelbyville, Tennessee, 37160, United States
Texas Oncology - West Texas
Abilene, Texas, 79606, United States
Texas Oncology - Northeast Texas
Allen, Texas, 75013, United States
Texas Oncology - West Texas
Amarillo, Texas, 79124, United States
Texas Oncology - Central/South Texas
Austin, Texas, 78758, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702, United States
Texas Oncology - Northeast Texas
Denison, Texas, 75020, United States
Texas Oncology - Northeast Texas
Denton, Texas, 76201, United States
Texas Oncology - West Texas
El Paso, Texas, 79902, United States
Texas Oncology - West Texas
El Paso, Texas, 79915, United States
Texas Oncology - West Texas
El Paso, Texas, 79938, United States
Texas Oncology - Northeast Texas
Flower Mound, Texas, 75028, United States
Texas Oncology - Central/South Texas
Harlingen, Texas, 78550, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77024, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77054, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77070, United States
Texas Oncology - Gulf Coast
Humble, Texas, 77338, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center
Irving, Texas, 75063, United States
Texas Oncology - Northeast Texas
Lewisville, Texas, 75056, United States
Texas Oncology - Northeast Texas
Longview, Texas, 75601, United States
Texas Oncology - Central/South Texas
McAllen, Texas, 78503, United States
Texas Oncology - Northeast Texas
McKinney, Texas, 75071, United States
Texas Oncology - West Texas
Midland, Texas, 79701, United States
Texas Oncology - West Texas
Odessa, Texas, 79761, United States
Texas Oncology - Northeast Texas
Palestine, Texas, 75801, United States
Texas Oncology - Northeast Texas
Paris, Texas, 75460, United States
Texas Oncology - Gulf Coast
Pearland, Texas, 77584, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380, United States
Texas Oncology - Northeast Texas
Tyler, Texas, 75702, United States
Texas Oncology - Central/South Texas
Waco, Texas, 76712, United States
Texas Oncology - Gulf Coast
Webster, Texas, 77598, United States
Texas Oncology - Central/South Texas
Weslaco, Texas, 78596, United States
Texas Oncology - West Texas
Wichita Falls, Texas, 76310, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684, United States
Minnesota Oncology Hematology, P.A.
Hudson, Wisconsin, 54016, United States
Investigaciones Clinicas Moleculares (ICM)
CABA, Buenos Aires, 1425, Argentina
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1122AAL, Argentina
Clinica Adventista Belgrano
CABA, Buenos Aires F.D., C1430EGF, Argentina
Hospital Italiano de Córdoba
Córdoba, Córdoba Province, X5004BAL, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, F5300COE, Argentina
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Gympie Hospital
Gympie, Queensland, 4570, Australia
Nambour General Hospital
Nambour, Queensland, 4560, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, 7000, Australia
St Vincent's Hospital
Melbourne, Victoria, 3065, Australia
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
Montreal, Quebec, H4J 1C5, Canada
Shanghai East Hospital
Shanghai, 200123, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430048, China
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, 703 84, Czechia
Fakultni Thomayerova nemocnice
Prague, 140 59, Czechia
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, Haute Vienne, 87042, France
Institut de Cancérologie de l'Ouest
Angers, Maine ET Loire, 49055, France
Hôpital Ambroise Paré
Boulogne-Billancourt, Île-de-France Region, 92100, France
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002, India
KLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi, Karnataka, 590010, India
Apex Wellness Hospital
Nashik, Maharashtra, 422009, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Bhakti Vedanta Hospital and Research Institute
Thane, Maharashtra, 401107, India
Sheba Medical Center
Ramat Gan, HA Merkaz, 5265601, Israel
Yitzhak Shamir Medical Center
Ẕerifin, HA Merkaz, 70300, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 6423906, Israel
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kobe Minimally Invasive Cancer Center
Kobe, Hyōgo, 650-0046, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
NHO Mito Medical Center
Higashiibaraki, Ibaraki, 311-3117, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650, Japan
Mie Chuo Medical Center
Tsu, Mie-ken, 514-1101, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, 856-8562, Japan
National Hospital Organization Beppu Medical Center
Beppu, Oita Prefecture, 874-0011, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
The University of Osaka Hospital
Suita, Osaka, 565-0871, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
National Hospital Organization Tokyo National Hospital
Kiyose, Tokyo, 204-8585, Japan
National Center for Global Health and Medicine
Shinjyuku-ku, Tokyo, 162-8655, Japan
National Hospital Organization Yamaguchi Ube Medical Center
Ube, Yamaguchi, 755-0241, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
National Hospital Organization Kochi National Hospital
Kochi, 780-8077, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Pan American Center for Oncology Trials, LLC- Dorado Office
Dorado, 00646, Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
BRCR Global Puerto Rico - Hato Rey
San Juan, 00917, Puerto Rico
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [barcelona], 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407, Spain
Institut Català d'Oncologia (ICO) - Girona
Girona, Girona [gerona], 17007, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041, Spain
Hospital Universitario San Cecilio
Granada, 18016, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitari Son Espases
Palma, 07120, Spain
Changhua Christian Hospital
Changhua County, Changhua, 50006, Taiwan
National Taiwan University Hospital - Hsinchu branch
Hsinchu, 300195, Taiwan
Chung Shan Medical University Hospital
Taichung, 402306, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Istinye University - Liv Hospital - Topkapi
Istanbul, İstanbul, 34010, Turkey (Türkiye)
Medipol Mega Universite Hastanesi
Istanbul, İstanbul, 34214, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, İstanbul, 34722, Turkey (Türkiye)
Adana Medical Park Seyhan Hastanesi
Adana, 01140, Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, 21200, Turkey (Türkiye)
Samsun Medical Park Hastanesi
Samsun, 55200, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- This is double-blind study, neither the participants nor the study team will know whether the participants are receiving PF-08634404 or Pembrolizumab.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2025
First Posted
October 30, 2025
Study Start
January 6, 2026
Primary Completion (Estimated)
February 27, 2029
Study Completion (Estimated)
August 26, 2032
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.