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Un estudio para aprender sobre el medicamento de estudio denominado PF-08634404 en combinación con quimioterapia en participantes adultos con cáncer de pulmón de células pequeñas en estadio extenso

6 de octubre de 2026 actualizado por: Pfizer

UN ESTUDIO INTERVENCIONAL GLOBAL DE FASE 2/3 DE PF-08634404 EN COMBINACIÓN CON QUIMIOTERAPIA EN PARTICIPANTES CON CÁNCER DE PULMÓN DE CÉLULAS PEQUEÑAS EN ESTADIO EXTENSIVO

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

550

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
      • Düsseldorf, Alemania, 40479
        • Reclutamiento
        • Marien Hospital Düsseldorf
      • Frankfurt am Main, Alemania, 60488
        • Reclutamiento
        • Krankenhaus Nordwest GmbH
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Reclutamiento
        • Westmead Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Reclutamiento
        • Sunshine Coast University Hospital
  • España
      • Barcelona, España, 08035
        • Reclutamiento
        • Hospital Universitari Vall d'Hebron
      • Barcelona, España, 08003
        • Reclutamiento
        • Parc de Salut Mar - Hospital del Mar
      • Barcelona, España, 08029
        • Reclutamiento
        • CETIR
      • Jaén, España, 23007
        • Reclutamiento
        • Hospital Universitario de Jaen
    • Andalusia
      • Jaén, Andalusia, España, 23007
        • Reclutamiento
        • HT Médica Jaen LAs Nieves
    • Cádiz
      • Jerez de la Frontera, Cádiz, España, 11407
        • Reclutamiento
        • Hospital Jerez de la Frontera
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, España, 28041
        • Reclutamiento
        • Hospital Universitario 12 de Octubre
  • Estados Unidos
    • Arkansas
      • Fayetteville, Arkansas, Estados Unidos, 72703
        • Reclutamiento
        • Highlands Oncology Group
      • Rogers, Arkansas, Estados Unidos, 72758
        • Reclutamiento
        • Highlands Oncology Group
      • Springdale, Arkansas, Estados Unidos, 72762
        • Reclutamiento
        • Highlands Oncology Group
    • Florida
      • Coral Springs, Florida, Estados Unidos, 33065
        • Reclutamiento
        • BRCR Coral Springs
      • Orange City, Florida, Estados Unidos, 32763
        • Reclutamiento
        • Mid Florida Hematology and Oncology Center
      • Tamarac, Florida, Estados Unidos, 33321
        • Reclutamiento
        • BRCR Global - Tamarac
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106
        • Reclutamiento
        • University Hospitals Cleveland Medical Center
    • Texas
      • Allen, Texas, Estados Unidos, 75013
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • Arlington, Texas, Estados Unidos, 76012
        • Reclutamiento
        • Texas Oncology - DFW
      • Arlington, Texas, Estados Unidos, 76014
        • Reclutamiento
        • Texas Oncology - DFW
      • Beaumont, Texas, Estados Unidos, 77702
        • Reclutamiento
        • Texas Oncology - Gulf Coast
      • Bedford, Texas, Estados Unidos, 76022
        • Reclutamiento
        • Texas Oncology - DFW
      • Dallas, Texas, Estados Unidos, 75246
        • Reclutamiento
        • Texas Oncology - DFW
      • Dallas, Texas, Estados Unidos, 75203
        • Reclutamiento
        • Texas Oncology - DFW
      • Dallas, Texas, Estados Unidos, 75230
        • Reclutamiento
        • Texas Oncology - DFW
      • Dallas, Texas, Estados Unidos, 75231
        • Reclutamiento
        • Texas Oncology - DFW
      • Dallas, Texas, Estados Unidos, 75237
        • Reclutamiento
        • Texas Oncology - DFW
      • Denison, Texas, Estados Unidos, 75020
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • Denton, Texas, Estados Unidos, 76201
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • Flower Mound, Texas, Estados Unidos, 75028
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • Fort Worth, Texas, Estados Unidos, 76104
        • Reclutamiento
        • Texas Oncology - DFW
      • Fredericksburg, Texas, Estados Unidos, 78624
        • Reclutamiento
        • Texas Oncology - San Antonio
      • Grapevine, Texas, Estados Unidos, 76051
        • Reclutamiento
        • Texas Oncology - DFW
      • Houston, Texas, Estados Unidos, 77024
        • Reclutamiento
        • Texas Oncology - Gulf Coast
      • Houston, Texas, Estados Unidos, 77054
        • Reclutamiento
        • Texas Oncology - Gulf Coast
      • Irving, Texas, Estados Unidos, 75063
        • Reclutamiento
        • US Oncology Investigational Products Center (IPC)
      • Irving, Texas, Estados Unidos, 75063
        • Reclutamiento
        • US Oncology Investigational Product Center (IPC)
      • Lewisville, Texas, Estados Unidos, 75056
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • Longview, Texas, Estados Unidos, 75601
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • McKinney, Texas, Estados Unidos, 75071
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • New Braunfels, Texas, Estados Unidos, 78130
        • Reclutamiento
        • Texas Oncology - San Antonio
      • Palestine, Texas, Estados Unidos, 75801
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • Paris, Texas, Estados Unidos, 75460
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • Pearland, Texas, Estados Unidos, 77584
        • Reclutamiento
        • Texas Oncology - Gulf Coast
      • Plano, Texas, Estados Unidos, 75075
        • Reclutamiento
        • Texas Oncology - DFW
      • Plano, Texas, Estados Unidos, 75093
        • Reclutamiento
        • Texas Oncology - DFW
      • San Antonio, Texas, Estados Unidos, 78240
        • Reclutamiento
        • Texas Oncology - San Antonio
      • San Antonio, Texas, Estados Unidos, 78217
        • Reclutamiento
        • Texas Oncology - San Antonio
      • San Antonio, Texas, Estados Unidos, 78258
        • Reclutamiento
        • Texas Oncology - San Antonio
      • Sugar Land, Texas, Estados Unidos, 77479
        • Reclutamiento
        • Texas Oncology - Gulf Coast
      • The Woodlands, Texas, Estados Unidos, 77380
        • Reclutamiento
        • Texas Oncology - Gulf Coast
      • Tyler, Texas, Estados Unidos, 75702
        • Reclutamiento
        • Texas Oncology - Northeast Texas
      • Webster, Texas, Estados Unidos, 77598
        • Reclutamiento
        • Texas Oncology - Gulf Coast
    • Virginia
      • Blacksburg, Virginia, Estados Unidos, 24060
        • Reclutamiento
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Chesapeake, Virginia, Estados Unidos, 23320
        • Reclutamiento
        • Virginia Oncology Associates
      • Hampton, Virginia, Estados Unidos, 23666
        • Reclutamiento
        • Virginia Oncology Associates
      • Low Moor, Virginia, Estados Unidos, 24457
        • Reclutamiento
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Newport News, Virginia, Estados Unidos, 23606
        • Reclutamiento
        • Virginia Oncology Associates
      • Norfolk, Virginia, Estados Unidos, 23502
        • Reclutamiento
        • Virginia Oncology Associates
      • Roanoke, Virginia, Estados Unidos, 24014
        • Reclutamiento
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Salem, Virginia, Estados Unidos, 24153
        • Reclutamiento
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Virginia Beach, Virginia, Estados Unidos, 23456
        • Reclutamiento
        • Virginia Oncology Associates
      • Williamsburg, Virginia, Estados Unidos, 23188
        • Reclutamiento
        • Virginia Oncology Associates
      • Wytheville, Virginia, Estados Unidos, 24382
        • Reclutamiento
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Francia
      • Villejuif, Francia, 94805
        • Reclutamiento
        • Gustave Roussy
    • Île-de-France Region
      • Boulogne-Billancourt, Île-de-France Region, Francia, 92100
        • Reclutamiento
        • Hôpital Ambroise Paré
  • Italia
    • Pordenone
      • Aviano, Pordenone, Italia, 33081
        • Reclutamiento
        • Centro di Riferimento Oncologico (CRO) IRCCS
    • ROME
      • Roma, ROME, Italia, 00144
        • Reclutamiento
        • IRCCS Istituto Nazionale dei Tumori Regina Elena
    • Turin
      • Orbassano, Turin, Italia, 10043
        • Reclutamiento
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
  • Japón
    • Osaka
      • Hirakata, Osaka, Japón, 573-1191
        • Reclutamiento
        • Kansai Medical University Hospital
    • Shizuoka
      • Nagaizumi-cho, Shizuoka, Japón, 411-8777
        • Reclutamiento
        • Shizuoka Cancer Center
    • Tokyo
      • Kotoku, Tokyo, Japón, 135-8550
        • Reclutamiento
        • Japanese Foundation for Cancer Research
  • Porcelana
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510180
        • Reclutamiento
        • Guangdong Provincial People's Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200032
        • Reclutamiento
        • Fudan University Shanghai Cancer Center
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Reclutamiento
        • Doctor's Center Hematology & Oncology Group
      • Mayagüez, Puerto Rico, 00680
        • Reclutamiento
        • Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center
      • San Juan, Puerto Rico, 00935
        • Reclutamiento
        • Hospital Oncologico Dr. Isaac Gonzalez-Martinez
      • San Juan, Puerto Rico, 00909
        • Reclutamiento
        • Pan American Center for Oncology Trials LLC
  • Taiwán
      • Tainan, Taiwán, 704302
        • Reclutamiento
        • National Cheng Kung University Hospital
      • Taipei, Taiwán, 10002
        • Reclutamiento
        • National Taiwan University Hospital
      • Taipei, Taiwán, 110
        • Reclutamiento
        • Taipei Medical University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Phase 2 Single arm

Participants will receive PF-08634404 in combination with chemotherapy
Droga: Chemotherapy

Injection for intravenous use

Droga: PF-08634404

Concentrate for solution for infusion
Experimental: Phase 3 Experimental Arm

Participants will receive PF-08634404 in combination with chemotherapy
Droga: Chemotherapy

Injection for intravenous use

Droga: PF-08634404

Concentrate for solution for infusion
Comparador activo: Phase3 Control Arm

Participants will receive atezolizumab in combination with chemotherapy
Droga: Chemotherapy

Injection for intravenous use

Biológico: Atezolizumab

Injection for intravenous use

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 2: Number of participants with treatment-emergent adverse events
Periodo de tiempo: Up to 90 days after the last dose of treatment

Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Up to 90 days after the last dose of treatment
Phase 3: Overall Survival (OS)
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

OS is defined as the time from the date of randomization to the date of death due to any cause. OS is secondary outcome measure in Phase 2 portion of the study.
Up to approximately 2 years after completion of study treatment of last study participant

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Farmacocinética: Concentraciones séricas de PF-08634404
Periodo de tiempo: Hasta 37 días después de la última dosis del tratamiento
Hasta 37 días después de la última dosis del tratamiento
Incidencia de anticuerpos antifármaco contra PF-08634404
Periodo de tiempo: Hasta 37 días después de la última dosis del tratamiento
Hasta 37 días después de la última dosis del tratamiento
Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

DOR is defined as the time from the first documentation of objective response (CR or PR) to the date of first documentation of progressive disease (PD) or death due to any cause.
Up to approximately 2 years after completion of study treatment of last study participant
Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

PFS is defined as the time from the date of randomization to the date of first documented disease progression, per RECIST v1.1, or death to any cause, whichever occurs first
Up to approximately 2 years after completion of study treatment of last study participant
Number of participants with Laboratory abnormalities
Periodo de tiempo: Up to 90 days after the last dose of treatment

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Up to 90 days after the last dose of treatment
Phase 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT)
Periodo de tiempo: Up to 90 days after the last dose of treatment

DLT (any of the prespecified AEs that are attributable to study treatment(s), excluding toxicities clearly due to underlying disease or extraneous causes) rate estimated based on data from DLT-evaluable participants during the DLT evaluation period.
Up to 90 days after the last dose of treatment
Phase 2: Overall Survival
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: PFS using RECIST v1.1 as assessed by blinded independent central review (BICR)
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by BICR per RECIST v1.1, or death due to any cause, whichever occurs first.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Confirmed ORR using RECIST v1.1 as assessed by BICR
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by BICR.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: DOR using RECIST v1.1 as assessed by BICR
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Mean scores and Change from baseline in the global health status/quality of life (QoL), function, and symptom scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Mean scores and Change from Baseline on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

EORTC QLQ-LC13 is a lung cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire, the EORTC QLQ-C30.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: Time to definitive deterioration (TTdD) in the global health status/QoL, function, and symptom scores on the EORTC QLQ-C30
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Up to approximately 2 years after completion of study treatment of last study participant
Phase 3: TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
Periodo de tiempo: Up to approximately 2 years after completion of study treatment of last study participant

TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Up to approximately 2 years after completion of study treatment of last study participant

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Investigadores

  • Director de estudio: Pfizer CT.gov Call Center, Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de diciembre de 2025

Finalización primaria (Estimado)

14 de junio de 2030

Finalización del estudio (Estimado)

11 de marzo de 2034

Fechas de registro del estudio

Enviado por primera vez

7 de noviembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

7 de noviembre de 2025

Publicado por primera vez (Actual)

12 de noviembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • C6461004
  • 2025-523522-41-00 (Ctis)
  • Symbiotic-Lung-04 (Otro identificador: Pfizer)
  • 2025 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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