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NCT07226999RecruitingPhase 2/3

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

A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
550 (estimated)
First submitted
7 Nov 2025
Start date
9 Dec 2025
Primary completion date
14 Jun 2030
Lead sponsor
Pfizer
Diseases
Lung cancer
NCT number
NCT07226999
EU CT number
2025-523522-41-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 550
  • From 9 Dec 2025 to the primary completion date, 14 Jun 2030
  • 71 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (71)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sunshine Coast University Hospital
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BirtinyaAustraliaRecruiting
Westmead Hospital
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WestmeadAustraliaRecruiting
Guangdong Provincial People's Hospital
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GuangzhouChinaRecruiting
Fudan University Shanghai Cancer Center
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ShanghaiChinaRecruiting
Marien Hospital Duesseldorf GmbH
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DuesseldorfGermanyNot yet recruiting
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyNot yet recruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario de Jaén
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JaénSpainRecruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hôpital Ambroise-Paré
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Boulogne-BillancourtFranceNot yet recruiting
Institut Gustave Roussy
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VillejuifFranceNot yet recruiting
Centro di Riferimento Oncologico di Aviano
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AvianoItalyNot yet recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyNot yet recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyNot yet recruiting
Kansai Medical University Hospital
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HirakataJapanRecruiting
Japanese Foundation for Cancer Research
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KotokuJapanRecruiting
Shizuoka Cancer Center
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Nagaizumi-chōJapanRecruiting
Doctor's Center Hematology & Oncology Group
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ManatiPuerto RicoRecruiting
Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center
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MayagüezPuerto RicoRecruiting
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
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San JuanPuerto RicoRecruiting
Pan American Center for Oncology Trials LLC
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San JuanPuerto RicoRecruiting
National Cheng Kung University Hospital
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TainanTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Taipei Medical University Hospital
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TaipeiTaiwanRecruiting
Texas Oncology - Northeast Texas
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AllenUnited StatesRecruiting
Texas Oncology - DFW
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ArlingtonUnited StatesRecruiting
Texas Oncology - Gulf Coast
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BeaumontUnited StatesRecruiting
Texas Oncology - DFW
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BedfordUnited StatesRecruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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BlacksburgUnited StatesRecruiting
Virginia Oncology Associates
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ChesapeakeUnited StatesRecruiting
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesRecruiting
BRCR Coral Springs
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Coral SpringsUnited StatesRecruiting
Texas Oncology - DFW
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DallasUnited StatesRecruiting
Texas Oncology - Northeast Texas
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DenisonUnited StatesRecruiting
Texas Oncology - Northeast Texas
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DentonUnited StatesRecruiting
Highlands Oncology Group
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FayettevilleUnited StatesRecruiting
Texas Oncology - Northeast Texas
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Flower MoundUnited StatesRecruiting
Texas Oncology - DFW
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Fort WorthUnited StatesRecruiting
Texas Oncology - San Antonio
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FredericksburgUnited StatesRecruiting
Texas Oncology - DFW
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GrapevineUnited StatesRecruiting
Virginia Oncology Associates
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HamptonUnited StatesRecruiting
Texas Oncology - Gulf Coast
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HoustonUnited StatesRecruiting
US Oncology Investigational Product Center (IPC)
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IrvingUnited StatesRecruiting
US Oncology Investigational Products Center (IPC)
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IrvingUnited StatesRecruiting
Texas Oncology - Northeast Texas
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LewisvilleUnited StatesRecruiting
Texas Oncology - Northeast Texas
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LongviewUnited StatesRecruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Low MoorUnited StatesRecruiting
Texas Oncology - Northeast Texas
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McKinneyUnited StatesRecruiting
Texas Oncology - San Antonio
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New BraunfelsUnited StatesRecruiting
Virginia Oncology Associates
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Newport NewsUnited StatesRecruiting
Virginia Oncology Associates
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NorfolkUnited StatesRecruiting
Mid Florida Hematology and oncology Center
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Orange CityUnited StatesRecruiting
Texas Oncology - Northeast Texas
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PalestineUnited StatesRecruiting
Texas Oncology - Northeast Texas
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ParisUnited StatesRecruiting
Texas Oncology - Gulf Coast
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PearlandUnited StatesRecruiting
Texas Oncology - DFW
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PlanoUnited StatesRecruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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RoanokeUnited StatesRecruiting
Highlands Oncology Group
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RogersUnited StatesRecruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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SalemUnited StatesRecruiting
Texas Oncology - San Antonio
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San AntonioUnited StatesRecruiting
Highlands Oncology Group
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SpringdaleUnited StatesRecruiting
Texas Oncology - Gulf Coast
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Sugar LandUnited StatesRecruiting
BRCR Global- Tamarac
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TamaracUnited StatesRecruiting
Texas Oncology- Gulf Coast
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The WoodlandsUnited StatesRecruiting
Texas Oncology - Northeast Texas
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TylerUnited StatesRecruiting
Virginia Oncology Associates
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Virginia BeachUnited StatesRecruiting
Texas Oncology - Gulf Coast
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WebsterUnited StatesRecruiting
Virginia Oncology Associates
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WilliamsburgUnited StatesRecruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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WythevilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.