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Symbiotic-Lung-10: Uno studio per conoscere PF-08634404 da solo o in combinazione nel NSCLC in stadio iniziale o localmente avanzato

6 ottobre 2026 aggiornato da: Pfizer

UNO STUDIO INTERVENTISTICO, IN APERTO, DI FASE 2 PER INDAGARE SULLA SICUREZZA E L'EFFICACIA DI PF-08634404 IN MONOTERAPIA O IN COMBINAZIONE IN PARTECIPANTI ADULTI CON CARCINOMA POLMONARE NON A PICCOLE CELLULE IN FASE INIZIALE RESECABILE O LOCALMENTE AVANZATO NON RESECABILE

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Biologico: PF-08634404

Concentrate for solution for infusion

Altri nomi:
  • SSGJ-707
Droga: Chemotherapy Regimen 1

Injection for intravenous use

Droga: Chemotherapy Regimen 2

Injection for intravenous use
Sperimentale: 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.
Biologico: PF-08634404

Concentrate for solution for infusion

Altri nomi:
  • SSGJ-707
Sperimentale: 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.
Biologico: PF-08634404

Concentrate for solution for infusion

Altri nomi:
  • SSGJ-707

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Events (AEs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Farmacocinetica: Concentrazioni sieriche di PF-086344
Lasso di tempo: Fino a 37 giorni dopo l'ultima dose del trattamento, prima dell'intervento chirurgico
Fino a 37 giorni dopo l'ultima dose del trattamento, prima dell'intervento chirurgico
Incidenza di anticorpi anti-farmaco contro PF-08634404
Lasso di tempo: Fino a 37 giorni dopo l'ultima dose di trattamento, prima dell'intervento chirurgico
Fino a 37 giorni dopo l'ultima dose di trattamento, prima dell'intervento chirurgico
Part A: Major Pathological Response (MPR) rate per IASLC guidelines as assessed by central pathology review
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 giugno 2026

Completamento primario (Stimato)

29 luglio 2028

Completamento dello studio (Stimato)

30 luglio 2031

Date di iscrizione allo studio

Primo inviato

17 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 marzo 2026

Primo Inserito (Effettivo)

23 marzo 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C6461010
  • 2025-524825-42-00 (Identificatore di registro: CTIS (EU))
  • Symbiotic-Lung-10 (Altro identificatore: Alias Study Number)
  • 2025 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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