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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07227298

Registry updated: 2026-10-08
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Description

This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments. To join in the study, participants must: * Be 18 years or older * Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body The study will look at: * Whether PF-08634404 is safe to use with other cancer medicines. * What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease. * Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors. The study has different parts, each testing PF-08634404 with a different cancer medicine: * Part A will test PF-08634404 with a medicine called sigvotatug vedotin. * Part B will test PF-08634404 with a medicine called PF-08046054/SGN-PDL1V Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.

Interventions

  • PF-08634404 (Biological)
    -Concentrate for solution for infusion
  • Sigvotatug Vedotin (Biological)
    -Powder for concentrate for solution for infusion. Single use vial
  • PF-08046054/SGN-PDL1V (Biological)
    -Powder for concentrate for solution for infusion. Single use vial.

Eligibility criteria

Inclusion Criteria: * Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy * PD-L1 status available * Part B only: PD-L1 ≥ TPS 1% * Measurable disease based on RECIST v1.1 per investigator. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Adequate organ function Exclusion Criteria: * Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC) * History of another malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy * Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression * Leptomeningeal disease * Active autoimmune diseases requiring systemic treatment within the past 2 years * Previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC * Previous treatment with immunotherapy (exception is (neo)adjuvant or consolidation anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy \>30 Gy to the lung within 6 months of first dose of study intervention

Conditions

Advanced/Metastatic Non-Small Cell Lung Cancer Carcinoma, Non-Small Cell Lung Non-Small Cell Lung Cancer

Locations

  • Highlands Oncology Group, PA — Fayetteville, Arkansas, United States
  • Highlands Oncology Group, PA — Rogers, Arkansas, United States
  • Highlands Oncology Group, PA — Springdale, Arkansas, United States
  • Providence Medical Foundation — Fullerton, California, United States
  • Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center — Fullerton, California, United States
  • Providence St. Jude Medical Center — Fullerton, California, United States
  • Scripps Clinic Torrey Pines (Scripps Cancer Center) — La Jolla, California, United States
  • Scripps Green Hospital — La Jolla, California, United States
  • Scripps Shiley Pavilion — La Jolla, California, United States
  • START Los Angeles, LLC — Los Angeles, California, United States
  • LACN Century City — Los Angeles, California, United States
  • Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite) — Los Angeles, California, United States
  • Valkyrie Clinical Trials (Additional Site Suite) — Los Angeles, California, United States
  • Valkyrie Clinical Trials — Los Angeles, California, United States
  • Mission Community Hospital (Satellite Site) — Panorama City, California, United States
  • Rocky Mountain Cancer Centers,LLP — Aurora, Colorado, United States
  • Rocky Mountain Cancer Centers,LLP — Denver, Colorado, United States
  • Rocky Mountain Cancer Centers,LLP — Lone Tree, Colorado, United States
  • BRCR Medical Center Inc. — Coral Springs, Florida, United States
  • Moffitt Cancer Center- Speros — Land O' Lakes, Florida, United States
  • Mid Florida Hematology and Oncology Center — Orange City, Florida, United States
  • Orlando Health Ambulatory Care Center — Orlando, Florida, United States
  • Orlando Health Cancer Institute — Orlando, Florida, United States
  • Orlando Health Orlando Regional Medical Center — Orlando, Florida, United States
  • Moffitt Cancer Center - SouthShore — Ruskin, Florida, United States
  • BRCR Global - Tamarac — Tamarac, Florida, United States
  • Moffitt Cancer Center - International Plaza — Tampa, Florida, United States
  • Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States
  • Moffitt Cancer Center — Tampa, Florida, United States
  • Moffitt McKinley Hospital — Tampa, Florida, United States
  • Moffitt Cancer Center - Wesley Chapel — Wesley Chapel, Florida, United States
  • Hackensack University Medical Center — Hackensack, New Jersey, United States
  • John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Newman Street Imaging — Hackensack, New Jersey, United States
  • John Theurer Cancer Center at JSUMC — Neptune City, New Jersey, United States
  • Jack & Sheryl Morris Cancer Center — New Brunswick, New Jersey, United States
  • Robert Wood Johnson University Hospital (RWJBH) — New Brunswick, New Jersey, United States
  • Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
  • Rutgers Cancer Institute — New Brunswick, New Jersey, United States
  • John Theurer Cancer Center at From Road — Paramus, New Jersey, United States
  • Heart Center Glenpointe — Teaneck, New Jersey, United States
  • Montefiore Medical Center- Montefiore Medical Park — The Bronx, New York, United States
  • Oncology Associates of Oregon, P.C. — Eugene, Oregon, United States
  • Dallas Cancer Specialists — Garland, Texas, United States
  • Southwest Oncology Associates — Houston, Texas, United States
  • Lumi Research — Houston, Texas, United States
  • US Oncology Investigational Products Center (IPC) — Irving, Texas, United States
  • Voyage Clinical — Sugar Land, Texas, United States
  • VCU Medical Center Gateway Building — Richmond, Virginia, United States
  • Virginia Commonwealth University — Richmond, Virginia, United States
  • VCU Health Stony Point — Richmond, Virginia, United States
  • Massey Cancer Center Clinical & Translational Research Lab — Richmond, Virginia, United States
  • Virginia Commonwealth University — Richmond, Virginia, United States
  • VCU Health Community Memorial Hospital — South Hill, Virginia, United States
  • VCU Health Tappahannock Hospital — Tappahannock, Virginia, United States
  • Beijing Cancer hospital — Beijing, Beijing Municipality, China
  • Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
  • Fujian Cancer Hospital — Fuzhou, Fujian, China
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China
  • Jiangsu Province Hospital — Nanjing, Jiangsu, China
  • Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China
  • Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
  • Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China
  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux, Aquitaine, France
  • Centre Georges François Leclerc — Dijon, CÔTE D'OR, France
  • Institut Paoli-Calmettes — Marseille, Provence-Alpes-Côte d'Azur Region, France
  • Groupe hospitalier Paris saint Joseph — Paris, Île-de-France Region, France
  • Universitaetsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Krankenhaus Nordwest GmbH — Frankfurt am Main, Hesse, Germany
  • Marien Hospital Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany
  • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU) — Fano, Pesaro AND Urbino, Italy
  • IRCCS Istituto Nazionale dei Tumori Regina Elena — Roma, ROME, Italy
  • Ospedale Isola Tiberina - Gemelli Isola — Roma, ROME, Italy
  • National Cancer Center Hospital East — Kashiwa, Chiba, Japan
  • Sendai Kousei Hospital — Sendai, Miyagi, Japan
  • Kansai Medical University Hospital — Hirakata, Osaka, Japan
  • Shizuoka Cancer Center — Nagaizumi-cho, Shizuoka, Japan
  • Nippon Medical School Hospital — Bunkyo-ku, Tokyo, Japan
  • Tokyo Metropolitan Komagome Hospital — Bunkyo-ku, Tokyo, Japan
  • Pan American Center for Oncology Trials, LLC - Mayaguez — Mayagüez, Puerto Rico
  • Pan American Center for Oncology Trials, LLC — Rio Piedras, Puerto Rico
  • BRCR Global Puerto Rico - Hato Rey — San Juan, Puerto Rico
  • HT Médica Jaen LAs Nieves — Jaén, Andalusia, Spain
  • Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [barcelona], Spain
  • Hospital de la Santa Creu i Sant Pau — Barcelona, Catalunya [cataluña], Spain
  • Hospital Jerez de la Frontera — Jerez de la Frontera, Cádiz, Spain
  • Hospital Nuestra Señora del Rosario — Madrid, Madrid, Comunidad de, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Madrid, Comunidad de, Spain
  • Hospital Universitario Virgen de la Victoria — Málaga, Málaga, Spain
  • Clínica Radiólogica Mario Gallegos — Málaga, Málaga, Spain
  • Fundación Instituto Valenciano de Oncología — Valencia, Valenciana, Comunitat, Spain
  • Hospital Universitario Puerta del Mar — Cadiz, Spain
  • Hospital Universitario San Cecilio — Granada, Spain
  • Hospital Universitario de Jaen — Jaén, Spain
  • Hospital Clinico San Carlos — Madrid, Spain
  • Cadpet Malaga — Málaga, Spain
  • Hospital Universitario Virgen Macarena — Seville, Spain
  • VIVO Capuchinos — Seville, Spain
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • Chang Gung Memorial Hospital at Kaohsiung — Kaohsiung City, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Mackay Memorial Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record