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Symbiotic-Lung-10: En studie om PF-08634404 ensam eller i kombination vid tidig NSCLC eller lokalavancerad NSCLC

6 oktober 2026 uppdaterad av: Pfizer

EN INTERVENTIONELL, ÖPPEN, FAS 2-STUDIE FÖR ATT UNDERSÖKA SÄKERHETEN OCH EFFEKTEN AV PF-08634404 MONOTERAPI ELLER I KOMBINATION HOS VUXNA DELTAGARE MED TIDIG RESEKTABEL ELLER LOKALT AVANCERAD ICRESEKTABEL ICKE-SMÅCELLIG LUNGCANCER

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

120

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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

Andra namn:
  • SSGJ-707
Läkemedel: Chemotherapy Regimen 1

Injection for intravenous use

Läkemedel: Chemotherapy Regimen 2

Injection for intravenous use
Experimentell: 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

Andra namn:
  • SSGJ-707
Experimentell: 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

Andra namn:
  • SSGJ-707

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Adverse Events (AEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Farmakokinetik: Serumkoncentrationer av PF-086344
Tidsram: Upp till 37 dagar efter den sista behandlingsdosen, före operation
Upp till 37 dagar efter den sista behandlingsdosen, före operation
Förekomst av antidrogliknande antikropp mot PF-08634404
Tidsram: Upp till 37 dagar efter den sista behandlingsdosen, före operation
Upp till 37 dagar efter den sista behandlingsdosen, före operation
Part A: Major Pathological Response (MPR) rate per IASLC guidelines as assessed by central pathology review
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Utredare

  • Studierektor: Pfizer CT.gov Call Center, Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 juni 2026

Primärt slutförande (Beräknad)

29 juli 2028

Avslutad studie (Beräknad)

30 juli 2031

Studieregistreringsdatum

Först inskickad

17 mars 2026

Först inskickad som uppfyllde QC-kriterierna

17 mars 2026

Första postat (Faktisk)

23 mars 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C6461010
  • 2025-524825-42-00 (Registeridentifierare: CTIS (EU))
  • Symbiotic-Lung-10 (Annan identifierare: Alias Study Number)
  • 2025 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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