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NCT07226999PHASE2, PHASE3Recruiting

Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer

Pfizer

Start Date

12/9/2025

Completion Date

3/11/2034

Summary

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have extensive-stage small cell lung cancer confirmed by lab tests. * Have not received chemotherapy or radiation for this type of lung cancer. * Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better. Participants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC. * Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC * Have at least one measurable lesion as the targeted lesion based on RECIST V1.1. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Adequate organ function Exclusion Criteria: * known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression * Leptomeningeal disease * Clinically significant risk of hemorrhage or fistula * history of another malignancy within 3 years * active autoimmune diseases requiring systemic treatment within the past 2 years

Interventions

DRUG

PF-08634404

BIOLOGICAL

Atezolizumab

DRUG

Chemotherapy

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Conditions

Small Cell Lung Cancer (SCLC)

Locations

Highlands Oncology Group

Fayetteville, Arkansas 72703

United States

Highlands Oncology Group

Rogers, Arkansas 72758

United States

Highlands Oncology Group

Springdale, Arkansas 72762

United States

BRCR Coral Springs

Coral Springs, Florida 33065

United States

Mid Florida Hematology and Oncology Center

Orange City, Florida 32763

United States

BRCR Global - Tamarac

Tamarac, Florida 33321

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Texas Oncology - DFW

Arlington, Texas 76012

United States

Texas Oncology - DFW

Arlington, Texas 76014

United States

Texas Oncology - Gulf Coast

Beaumont, Texas 77702

United States

Texas Oncology - DFW

Bedford, Texas 76022

United States

Texas Oncology - DFW

Dallas, Texas 75203

United States

Texas Oncology - DFW

Dallas, Texas 75230

United States

Texas Oncology - DFW

Dallas, Texas 75231

United States

Texas Oncology - DFW

Dallas, Texas 75237

United States

Texas Oncology - DFW

Dallas, Texas 75246

United States

Texas Oncology - DFW

Fort Worth, Texas 76104

United States

Texas Oncology - San Antonio

Fredericksburg, Texas 78624

United States

Texas Oncology - DFW

Grapevine, Texas 76051

United States

Texas Oncology - Gulf Coast

Houston, Texas 77024

United States

Texas Oncology - Gulf Coast

Houston, Texas 77054

United States

US Oncology Investigational Product Center (IPC)

Irving, Texas 75063

United States

US Oncology Investigational Products Center (IPC)

Irving, Texas 75063

United States

US Oncology Investigational Products Center (IPC)

Irving, Texas 75063

United States

Texas Oncology - San Antonio

New Braunfels, Texas 78130

United States

Texas Oncology - Gulf Coast

Pearland, Texas 77584

United States

Texas Oncology - DFW

Plano, Texas 75075

United States

Texas Oncology - DFW

Plano, Texas 75093

United States

Texas Oncology - San Antonio

San Antonio, Texas 78217

United States

Texas Oncology - San Antonio

San Antonio, Texas 78240

United States

Texas Oncology - San Antonio

San Antonio, Texas 78258

United States

Texas Oncology - Gulf Coast

Sugar Land, Texas 77479

United States

Texas Oncology - Gulf Coast

The Woodlands, Texas 77380

United States

Texas Oncology - Gulf Coast

Webster, Texas 77598

United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Blacksburg, Virginia 24060

United States

Virginia Oncology Associates

Chesapeake, Virginia 23320

United States

Virginia Oncology Associates

Hampton, Virginia 23666

United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Low Moor, Virginia 24457

United States

Virginia Oncology Associates

Newport News, Virginia 23606

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Roanoke, Virginia 24014

United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Salem, Virginia 24153

United States

Virginia Oncology Associates

Virginia Beach, Virginia 23456

United States

Virginia Oncology Associates

Williamsburg, Virginia 23188

United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Wytheville, Virginia 24382

United States

Westmead Hospital

Westmead, New South Wales 2145

Australia

Sunshine Coast University Hospital

Birtinya, Queensland 4575

Australia

Guangdong Provincial People's Hospital

Guangzhou, Guangdong 510180

China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 200032

China

Gustave Roussy

Villejuif, 94805

France

Hôpital Ambroise Paré

Boulogne-Billancourt, Île-de-France Region 92100

France

Marien Hospital Düsseldorf

Düsseldorf, 40479

Germany

Krankenhaus Nordwest GmbH

Frankfurt am Main, 60488

Germany

Centro di Riferimento Oncologico (CRO) IRCCS

Aviano, Pordenone 33081

Italy

IRCCS Istituto Nazionale dei Tumori Regina Elena

Roma, ROME 00144

Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Turin 10043

Italy

Kansai Medical University Hospital

Hirakata, Osaka 573-1191

Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka 411-8777

Japan

Japanese Foundation for Cancer Research

Kotoku, Tokyo 135-8550

Japan

Doctor's Center Hematology & Oncology Group

Manati, 00674

Puerto Rico

Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center

Mayagüez, 00680

Puerto Rico

Pan American Center for Oncology Trials, LLC

San Juan, 00909

Puerto Rico

Hospital Oncologico Dr. Isaac Gonzalez-Martinez

San Juan, 00935

Puerto Rico

HT Médica Jaen LAs Nieves

Jaén, Andalusia 23007

Spain

Hospital Jerez de la Frontera

Jerez de la Frontera, Cádiz 11407

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de 28041

Spain

Parc de Salut Mar - Hospital del Mar

Barcelona, 08003

Spain

CETIR

Barcelona, 08029

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario de Jaen

Jaén, 23007

Spain

National Cheng Kung University Hospital

Tainan, 704302

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Medical University Hospital

Taipei, 110

Taiwan