Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Symbiotic-Lung-10: En undersøgelse for at lære om PF-08634404 alene eller i kombination i tidligstadiet eller lokalt fremskreden NSCLC

6. oktober 2026 opdateret af: Pfizer

EN INTERVENTIONEL, ÅBEN-LABELET, FAZE 2-STUDIE TIL AT UNDERSØGE SIKKERHEDEN OG EFFEKTEN AF PF-08634404 MONOTERAPI ELLER I KOMBINATION HOS VOKSNE DELTAGERE MED TIDLIGT STADIE RESEKABEL ELLER LOKALT FREMSKREDEN IKKE-RESEKABEL IKKE-SMÅCELLET LUNGEKRÆFT

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
    • Victoria
      • St Albans, Victoria, Australien, 3021
        • Rekruttering
        • Western Health-Sunshine & Footscray Hospitals
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35805
        • Rekruttering
        • Clearview Cancer Institute
      • Huntsville, Alabama, Forenede Stater, 35801
        • Rekruttering
        • Clearview Cancer Institute (Crestwood)
    • California
      • Stanford, California, Forenede Stater, 94305
        • Rekruttering
        • Stanford Hospital and Clinics
      • Stanford, California, Forenede Stater, 94305
        • Rekruttering
        • Stanford Cancer Institute
      • Stanford, California, Forenede Stater, 94305
        • Rekruttering
        • Stanford Hospital Investigational Drug Services
    • Georgia
      • Athens, Georgia, Forenede Stater, 30607
        • Rekruttering
        • University Cancer & Blood Center, LLC
    • Illinois
      • Hinsdale, Illinois, Forenede Stater, 60521
        • Rekruttering
        • Hope and Healing Clinical Research
      • New Lenox, Illinois, Forenede Stater, 60451
        • Rekruttering
        • Hope and Healing Clinical Research
    • Nebraska
      • Bellevue, Nebraska, Forenede Stater, 68123
        • Ikke rekrutterer endnu
        • Nebraska Medicine- Bellevue Medical Center
      • Lincoln, Nebraska, Forenede Stater, 68516
        • Rekruttering
        • Cancer Partners of Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • Ikke rekrutterer endnu
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Forenede Stater, 68105
        • Ikke rekrutterer endnu
        • Nebraska Medicine
      • Omaha, Nebraska, Forenede Stater, 68118
        • Ikke rekrutterer endnu
        • Nebraska Medicine - Village Pointe
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • Rekruttering
        • New Mexico Oncology Hematology Consultants, Ltd
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • Rekruttering
        • University of Tennessee Medical Center
  • Hong Kong
      • Hong Kong, Hong Kong
        • Ikke rekrutterer endnu
        • Prince of Wales Hospital
  • Israel
    • TELL ABĪB
      • Tel Aviv, TELL ABĪB, Israel, 6423906
        • Rekruttering
        • Sourasky Medical Center
  • Italien
    • Verona
      • Peschiera del Garda, Verona, Italien, 37019
        • Ikke rekrutterer endnu
        • Casa di Cura Dott. Pederzoli
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Rekruttering
        • Beijing Cancer hospital
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510180
        • Rekruttering
        • Guangdong Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, Kina, 250117
        • Rekruttering
        • The Affiliated Cancer Hospital of Shandong First Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Rekruttering
        • Fudan University Shanghai Cancer Center
  • Polen
      • Wroclaw, Polen, 53-439
        • Rekruttering
        • Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Rekruttering
        • Pan American Center for Oncology Trials, LLC - Bayamón Office
      • Manati, Puerto Rico, 00674
        • Rekruttering
        • Pan American Center for Oncology Trials, LLC - Manati Office
      • Ponce, Puerto Rico, 00730
        • Rekruttering
        • Pan American Center for Oncology Trials, LLC - Ponce Office
      • Rio Piedras, Puerto Rico, 00935
        • Rekruttering
        • Hospital Oncologico Dr. Isaac Gonzalez Martinez
      • San Juan, Puerto Rico, 00909
        • Rekruttering
        • Pan American Center for Oncology Trials, LLC - Ciudadela Office
  • Spanien
      • Majadahonda, Spanien, 28222
        • Rekruttering
        • Hospital Universitario Puerta de Hierro de Majadahonda
  • Taiwan
      • Taichung, Taiwan, 40201
        • Rekruttering
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 704
        • Rekruttering
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • Ikke rekrutterer endnu
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Rekruttering
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 110
        • Rekruttering
        • Taipei Medical University Hospital
  • Tyskland
      • Großhansdorf, Tyskland, 22927
        • Ikke rekrutterer endnu
        • LungenClinic Grosshansdorf
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Tyskland, 40479
        • Ikke rekrutterer endnu
        • Marien Hospital Düsseldorf

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: PF-08634404

Concentrate for solution for infusion

Andre navne:
  • SSGJ-707
Medicin: Chemotherapy Regimen 1

Injection for intravenous use

Medicin: Chemotherapy Regimen 2

Injection for intravenous use
Eksperimentel: 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.
Biologisk: PF-08634404

Concentrate for solution for infusion

Andre navne:
  • SSGJ-707
Eksperimentel: 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.
Biologisk: PF-08634404

Concentrate for solution for infusion

Andre navne:
  • SSGJ-707

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events (AEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Farmakokinetik: Serumkoncentrationer af PF-086344
Tidsramme: Op til 37 dage efter sidste behandlingsdosis, inden operation
Op til 37 dage efter sidste behandlingsdosis, inden operation
Forekomst af antidrug-antistof mod PF-08634404
Tidsramme: Op til 37 dage efter den sidste behandlingsdosis, før operationen
Op til 37 dage efter den sidste behandlingsdosis, før operationen
Part A: Major Pathological Response (MPR) rate per IASLC guidelines as assessed by central pathology review
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juni 2026

Primær færdiggørelse (Anslået)

29. juli 2028

Studieafslutning (Anslået)

30. juli 2031

Datoer for studieregistrering

Først indsendt

17. marts 2026

Først indsendt, der opfyldte QC-kriterier

17. marts 2026

Først opslået (Faktiske)

23. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C6461010
  • 2025-524825-42-00 (Registry Identifier: CTIS (EU))
  • Symbiotic-Lung-10 (Anden identifikator: Alias Study Number)
  • 2025 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner