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Symbiotic-Lung-10: Un estudio para conocer PF-08634404 solo o en combinación en NSCLC en estadio temprano o localmente avanzado

6 de octubre de 2026 actualizado por: Pfizer

UN ESTUDIO INTERVENCIONISTA, ABIERTO, DE FASE 2 PARA INVESTIGAR LA SEGURIDAD Y EFICACIA DE PF-08634404 EN MONOTERAPIA O EN COMBINACIÓN EN PARTICIPANTES ADULTOS CON CÁNCER DE PULMÓN DE CÉLULAS NO PEQUEÑAS RESECABLE EN ETAPA TEMPRANA O LOCALMENTE AVANZADO NO RESECABLE

This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.

The study is seeking participants who:

  • Are aged 18 years or older

  • Have either:

    • Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.
    • Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.
    • Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.

  • Be in good physical condition and have healthy organs based on medical tests.

  • Do not have known actionable changes in DNA

The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:

  • Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.
  • Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.
  • Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.

All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

120

Fase

  • Fase 2

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
      • Großhansdorf, Alemania, 22927
        • Aún no reclutando
        • LungenClinic Grosshansdorf
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Alemania, 40479
        • Aún no reclutando
        • Marien Hospital Düsseldorf
  • Australia
    • Victoria
      • St Albans, Victoria, Australia, 3021
        • Reclutamiento
        • Western Health-Sunshine & Footscray Hospitals
  • España
      • Majadahonda, España, 28222
        • Reclutamiento
        • Hospital Universitario Puerta de Hierro de Majadahonda
  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos, 35805
        • Reclutamiento
        • Clearview Cancer Institute
      • Huntsville, Alabama, Estados Unidos, 35801
        • Reclutamiento
        • Clearview Cancer Institute (Crestwood)
    • California
      • Stanford, California, Estados Unidos, 94305
        • Reclutamiento
        • Stanford Hospital and Clinics
      • Stanford, California, Estados Unidos, 94305
        • Reclutamiento
        • Stanford Cancer Institute
      • Stanford, California, Estados Unidos, 94305
        • Reclutamiento
        • Stanford Hospital Investigational Drug Services
    • Georgia
      • Athens, Georgia, Estados Unidos, 30607
        • Reclutamiento
        • University Cancer & Blood Center, LLC
    • Illinois
      • Hinsdale, Illinois, Estados Unidos, 60521
        • Reclutamiento
        • Hope and Healing Clinical Research
      • New Lenox, Illinois, Estados Unidos, 60451
        • Reclutamiento
        • Hope and Healing Clinical Research
    • Nebraska
      • Bellevue, Nebraska, Estados Unidos, 68123
        • Aún no reclutando
        • Nebraska Medicine- Bellevue Medical Center
      • Lincoln, Nebraska, Estados Unidos, 68516
        • Reclutamiento
        • Cancer Partners of Nebraska
      • Omaha, Nebraska, Estados Unidos, 68198
        • Aún no reclutando
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Estados Unidos, 68105
        • Aún no reclutando
        • Nebraska Medicine
      • Omaha, Nebraska, Estados Unidos, 68118
        • Aún no reclutando
        • Nebraska Medicine - Village Pointe
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87109
        • Reclutamiento
        • New Mexico Oncology Hematology Consultants, Ltd
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37920
        • Reclutamiento
        • University of Tennessee Medical Center
  • Hong Kong
      • Hong Kong, Hong Kong
        • Aún no reclutando
        • Prince of Wales Hospital
  • Israel
    • TELL ABĪB
      • Tel Aviv, TELL ABĪB, Israel, 6423906
        • Reclutamiento
        • Sourasky Medical Center
  • Italia
    • Verona
      • Peschiera del Garda, Verona, Italia, 37019
        • Aún no reclutando
        • Casa di Cura Dott. Pederzoli
  • Polonia
      • Wroclaw, Polonia, 53-439
        • Reclutamiento
        • Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
  • Porcelana
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100142
        • Reclutamiento
        • Beijing Cancer hospital
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510180
        • Reclutamiento
        • Guangdong Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, Porcelana, 250117
        • Reclutamiento
        • The Affiliated Cancer Hospital of Shandong First Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200032
        • Reclutamiento
        • Fudan University Shanghai Cancer Center
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Reclutamiento
        • Pan American Center for Oncology Trials, LLC - Bayamón Office
      • Manati, Puerto Rico, 00674
        • Reclutamiento
        • Pan American Center for Oncology Trials, LLC - Manati Office
      • Ponce, Puerto Rico, 00730
        • Reclutamiento
        • Pan American Center for Oncology Trials, LLC - Ponce Office
      • Rio Piedras, Puerto Rico, 00935
        • Reclutamiento
        • Hospital Oncologico Dr. Isaac Gonzalez Martinez
      • San Juan, Puerto Rico, 00909
        • Reclutamiento
        • Pan American Center for Oncology Trials, LLC - Ciudadela Office
  • Taiwán
      • Taichung, Taiwán, 40201
        • Reclutamiento
        • Chung Shan Medical University Hospital
      • Tainan, Taiwán, 704
        • Reclutamiento
        • National Cheng Kung University Hospital
      • Taipei, Taiwán, 100
        • Aún no reclutando
        • National Taiwan University Hospital
      • Taipei, Taiwán, 11217
        • Reclutamiento
        • Taipei Veterans General 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:

  • 18 years of age or older at screening.
  • Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
  • PD-L1 status available based on local testing results
  • Adequate organ function
  • Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
  • Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his/her practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.
  • Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.
  • Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.

Exclusion Criteria:

  • Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.

  • Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.

  • Participants with clinically significant risk of hemorrhage or fistula are excluded.

  • Participants with any 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.

  • Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.

  • Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.

  • History of allogeneic organ / hematopoietic stem cell transplantation.

  • Participants with any of the following respiratory conditions:

    • Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
    • Grade ≥3 pulmonary disease unrelated to underlying malignancy

  • History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events.

  • Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention.

  • History of severe bleeding tendency or coagulation dysfunction

  • History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.

  • Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).

  • Participants with history of immunodeficiency

  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.

  • Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Part A: Neoadjuvant PF-08634404 + Chemotherapy

Participants with treatment naïve early-stage or locally advanced, resectable NSCLC without Actionable Genomic Alterations (AGAs) who are candidates for neoadjuvant treatment will receive intravenous (IV) PF-08634404 in combination with chemotherapy.
Biológico: PF-08634404

Concentrate for solution for infusion

Otros nombres:
  • SSGJ-707
Droga: Chemotherapy Regimen 1

Injection for intravenous use

Droga: Chemotherapy Regimen 2

Injection for intravenous use
Experimental: Part B: Adjuvant PF-08634404 Monotherapy

Participants with early-stage or locally advanced, resectable NSCLC without AGAs who did not achieve pCR after standard-of-care (SOC) neoadjuvant chemo-immunotherapy and are candidates for adjuvant treatment will receive PF-08634404 IV.
Biológico: PF-08634404

Concentrate for solution for infusion

Otros nombres:
  • SSGJ-707
Experimental: Part C: PF-08634404 Monotherapy Consolidation after Definitive Chemoradiotherapy

Participants with locally advanced, unresectable NSCLC without AGAs who did not have progressive disease per RECIST 1.1 after definitive, platinum-based concurrent chemoradiotherapy (cCRT) and are candidates for consolidation treatment will receive PF-08634404 IV.
Biológico: PF-08634404

Concentrate for solution for infusion

Otros nombres:
  • SSGJ-707

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Adverse Events (AEs)
Periodo de tiempo: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).
Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)
Part A: Surgical Feasibility Rate
Periodo de tiempo: Up to approximately 6 months after first dose

Surgical Feasibility rate is defined by the proportion of participants undergoing surgery and the proportion of participants with wound complications after surgery.
Up to approximately 6 months after first dose
Part A: Pathological Complete Response (pCR) rate per International Association for the Study of Lung Cancer (IASLC) guidelines as assessed by central pathology review
Periodo de tiempo: Up to approximately 6 months after first dose

pCR rate by central pathology review is defined as the proportion of participants having pCR as assessed by central pathologist. pCR is defined as the absence of residual tumor in surgical specimens
Up to approximately 6 months after first dose

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Farmacocinética: Concentraciones séricas de PF-086344
Periodo de tiempo: Hasta 37 días después de la última dosis del tratamiento, antes de la cirugía
Hasta 37 días después de la última dosis del tratamiento, antes de la cirugía
Incidencia de anticuerpos antifármaco contra PF-08634404
Periodo de tiempo: Hasta 37 días después de la última dosis del tratamiento, antes de la cirugía
Hasta 37 días después de la última dosis del tratamiento, antes de la cirugía
Part A: Major Pathological Response (MPR) rate per IASLC guidelines as assessed by central pathology review
Periodo de tiempo: Up to approximately 6 months after first dose

MPR rate by central pathology review is defined as the proportion of participants having MPR as assessed by central pathologist or investigator respectively. MPR is defined as ≤10% residual tumor in surgical specimens.
Up to approximately 6 months after first dose
Part A: pCR rate per IASLC guidelines as assessed by investigator
Periodo de tiempo: Up to approximately 6 months after first dose

pCR rate by investigator is defined as the proportion of participants having pCR as assessed by investigator. pCR is defined as the absence of residual tumor in surgical specimens.
Up to approximately 6 months after first dose
Part A: MPR rate per IASLC guidelines as assessed by investigator
Periodo de tiempo: Up to approximately 6 months after first dose

MPR rate by investigator is defined as the proportion of participants having MPR as assessed by central pathologist or investigator respectively. MPR is defined as ≤10% residual tumor in surgical specimens.
Up to approximately 6 months after first dose
Part A: Event Free Survival (EFS) per RECIST v1.1 as assessed by investigator
Periodo de tiempo: Up to approximately 5 years

EFS is defined as time from the date of first dose to the first occurrence of disease progression precluding surgery, inability to resect the tumor, disease progression or recurrence after surgery per RECIST v1.1 as assessed by investigator, or death due to any cause.
Up to approximately 5 years
Part A: Objective Response Rate (ORR) per RECIST v1.1 as assessed by investigator at the completion of neoadjuvant therapy, prior to surgery
Periodo de tiempo: Up to approximately 5 years

ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) per RECIST v1.1.
Up to approximately 5 years
Part B: Disease Free Survival (DFS) per RECIST v1.1 as assessed by investigator
Periodo de tiempo: Up to approximately 5 years

DFS is defined as time from the date of first dose to the date of first documented disease progression or recurrence per RECIST v1.1 as assessed by investigator or death due to any cause, whichever occurs first
Up to approximately 5 years
Part C: Confirmed ORR per RECIST v1.1 as assessed by investigator
Periodo de tiempo: Up to approximately 5 years

Confirmed 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 investigator.
Up to approximately 5 years
Part C: Progression Free Survival (PFS) per RECIST v1.1 as assessed by investigator
Periodo de tiempo: Up to approximately 5 years

PFS is defined as the time from the date of first dose to the date of the first documentation of objective Progression Disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first
Up to approximately 5 years
Overall Survival (OS)
Periodo de tiempo: Up to approximately 5 years

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 5 years
Rate of circulating tumor DNA (ctDNA) reduction or clearance
Periodo de tiempo: Part A: Up to 18 months, Part B and Part C: Up to 37 days after the last dose of treatment

Reduction in ctDNA is defined as a decrease in ctDNA burden from baseline to a specified on-treatment time point. ctDNA clearance is defined as a 100% reduction in ctDNA burden.
Part A: Up to 18 months, Part B and Part C: Up to 37 days after the last dose of treatment
Number of participants with Laboratory abnormalities
Periodo de tiempo: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0).
Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

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)

30 de junio de 2026

Finalización primaria (Estimado)

29 de julio de 2028

Finalización del estudio (Estimado)

30 de julio de 2031

Fechas de registro del estudio

Enviado por primera vez

17 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de marzo de 2026

Publicado por primera vez (Actual)

23 de marzo de 2026

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

  • C6461010
  • 2025-524825-42-00 (Identificador de registro: CTIS (EU))
  • Symbiotic-Lung-10 (Otro identificador: Alias Study Number)
  • 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.

Sí

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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