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NCT07227298PHASE1, PHASE2Recruiting

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

Pfizer

Start Date

1/30/2026

Completion Date

8/23/2033

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

PF-08634404

BIOLOGICAL

Sigvotatug Vedotin

BIOLOGICAL

Combination Agent 1

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Conditions

Advanced/Metastatic Non-Small Cell Lung CancerCarcinoma, Non-Small Cell LungNon-Small Cell Lung Cancer

Locations

Highlands Oncology Group, PA

Fayetteville, Arkansas 72703

United States

Highlands Oncology Group, PA

Rogers, Arkansas 72758

United States

Highlands Oncology Group, PA

Springdale, Arkansas 72762

United States

Providence Medical Foundation

Fullerton, California 92835

United States

Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center

Fullerton, California 92835

United States

Providence St. Jude Medical Center

Fullerton, California 92835

United States

Valkyrie Clinical Trials (Additional Site Pharmacy Storage Suite)

Los Angeles, California 90067

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

Mission Community Hospital (Satellite Site)

Panorama City, California 91402

United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado 80218

United States

BRCR Medical Center Inc.

Coral Springs, Florida 33065

United States

Mid Florida Hematology and Oncology Center

Orange City, Florida 32763

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

BRCR Global - Tamarac

Tamarac, Florida 33321

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Newman Street Imaging

Hackensack, New Jersey 07601

United States

John Theurer Cancer Center at JSUMC

Neptune City, New Jersey 07753

United States

John Theurer Cancer Center at From Road

Paramus, New Jersey 07652

United States

Heart Center Glenpointe

Teaneck, New Jersey 07666

United States

Montefiore Medical Center- Montefiore Medical Park

The Bronx, New York 10461

United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon 97401

United States

Dallas Cancer Specialists

Garland, Texas 75042

United States

Southwest Oncology Associates

Houston, Texas 77030

United States

Lumi Research

Houston, Texas 77090

United States

US Oncology Investigational Products Center (IPC)

Irving, Texas 75063

United States

Voyage Clinical

Sugar Land, Texas 77479

United States

VCU Medical Center Gateway Building

Richmond, Virginia 23219

United States

Virginia Commonwealth University

Richmond, Virginia 23219

United States

VCU Health Stony Point

Richmond, Virginia 23235

United States

Massey Cancer Center Clinical & Translational Research Lab

Richmond, Virginia 23298

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States

VCU Health Community Memorial Hospital

South Hill, Virginia 23970

United States

VCU Health Tappahannock Hospital

Tappahannock, Virginia 22560

United States

Beijing Cancer hospital

Beijing, Beijing Municipality 100142

China

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei 430030

China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality 200030

China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang 317000

China

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine 33076

France

Centre Georges François Leclerc

Dijon, CÔTE D'OR 21079

France

Institut Paoli-Calmettes

Marseille, Provence-Alpes-Côte d'Azur Region 13273

France

Marien Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia 40479

Germany

Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)

Fano, Pesaro AND Urbino 61032

Italy

IRCCS Istituto Nazionale dei Tumori Regina Elena

Roma, ROME 00144

Italy

Ospedale Isola Tiberina - Gemelli Isola

Roma, ROME 00186

Italy

Kansai Medical University Hospital

Hirakata, Osaka 573-1191

Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka 411-8777

Japan

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935

Puerto Rico

BRCR Global Puerto Rico - Hato Rey

San Juan, 00917

Puerto Rico

HT Médica Jaen LAs Nieves

Jaén, Andalusia 23007

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona] 08035

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [cataluña] 08041

Spain

Hospital Jerez de la Frontera

Jerez de la Frontera, Cádiz 11407

Spain

Hospital Nuestra Señora del Rosario

Madrid, Madrid, Comunidad de 280006

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de 28041

Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga 29010

Spain

Clínica Radiólogica Mario Gallegos

Málaga, Málaga 29016

Spain

Fundación Instituto Valenciano de Oncología

Valencia, Valenciana, Comunitat 46009

Spain

Hospital Universitario Puerta del Mar

Cadiz, 11009

Spain

Hospital Universitario San Cecilio

Granada, 18016

Spain

Hospital Universitario de Jaen

Jaén, 23007

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Cadpet Malaga

Málaga, 29006

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

VIVO Capuchinos

Seville, 41009

Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung City, 83301

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Mackay Memorial Hospital

Taipei, 10449

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan