Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
Recruiting · NCT07227298 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 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 of the study will look at how well the new medicine PF-08634404 works when used together with another medicine. 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.
Who can take part
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
- 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
- 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, unresectable, or metastatic NSCLC
- Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention
Where it is running
60 locations listed across 9 US states.
- 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
- Valkyrie Clinical Trials (Additional Site Pharmacy Storage 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 - Denver, Colorado, United States
- BRCR Medical Center Inc. - Coral Springs, 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
- BRCR Global - Tamarac - Tamarac, 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
- 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
- Hospital Universitario Puerta del Mar - Cadiz, Spain
- Hospital Universitario San Cecilio - Granada, Spain
- Hospital Universitario de Jaen - Jaén, Spain
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- Chang Gung Memorial Hospital at Kaohsiung - Kaohsiung City, Taiwan
- Hospital Clinico San Carlos - Madrid, Spain
- Cadpet Malaga - Málaga, Spain
- Pan American Center for Oncology Trials, LLC - Rio Piedras, Puerto Rico
- BRCR Global Puerto Rico - Hato Rey - San Juan, Puerto Rico
- Hospital Universitario Virgen Macarena - Seville, Spain
- VIVO Capuchinos - Seville, Spain
- National Cheng Kung University Hospital - Tainan, Taiwan
- National Taiwan University Hospital - Taipei, Taiwan
- Mackay Memorial Hospital - Taipei, Taiwan
- Taipei Veterans General Hospital - Taipei, Taiwan
- HT Médica Jaen LAs Nieves - Jaén, Andalusia, Spain
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest - Bordeaux, Aquitaine, France
- Hospital Universitari Vall d'Hebron - Barcelona, Barcelona [barcelona], Spain
- Beijing Cancer hospital - Beijing, Beijing Municipality, China
- Hospital de la Santa Creu i Sant Pau - Barcelona, Catalunya [cataluña], Spain
- Centre Georges François Leclerc - Dijon, CÔTE D'OR, France
- Hospital Jerez de la Frontera - Jerez de la Frontera, Cádiz, Spain
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology - Wuhan, Hubei, China
- Hospital Nuestra Señora del Rosario - Madrid, Madrid, Comunidad de, Spain
Showing 60 of 73 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →