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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

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Category

Thoracic Cancer

PD-1x VEGF bispecific antibody

PF-08634404 | PF'4404 is an investigational compound.  Its safety and efficacy have not been established.

AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER

Phase 2

NCT07489066

Active enrolling

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Locations

United States, China, Israel, Puerto Rico, Taiwan

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Study design
Participant Group/Arm

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.

Intervention/Treatment

BIOLOGICAL: PF-08634404

Concentrate for solution for infusion

DRUG: Chemotherapy Regimen 1

Injection for intravenous use

DRUG: Chemotherapy Regimen 2

Injection for intravenous use
Participant Group/Arm

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.

Intervention/Treatment

BIOLOGICAL: PF-08634404

Concentrate for solution for infusion
Participant Group/Arm

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.

Intervention/Treatment

BIOLOGICAL: PF-08634404

Concentrate for solution for infusion
Study design table for Clinical Trial
Key eligibility criteria
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 malignan
  • 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.
    • Key dates
    Study start date
    • June 2026
    Estimated Study Completion Date
    • July 2031
    Key endpoints
    Primary Outcome Measures
    Outcome Measure

    Number of Participants With Adverse Events (AEs)

    Measure Description

    AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).

    Time Frame

    Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

    Outcome Measure

    Part A: Surgical Feasibility Rate

    Measure Description

    Surgical Feasibility rate is defined by the proportion of participants undergoing surgery and the proportion of participants with wound complications after surgery.

    Time Frame

    Up to approximately 6 months after first dose

    Outcome Measure

    Part A: Pathological Complete Response (pCR) rate per International Association for the Study of Lung Cancer (IASLC) guidelines as assessed by central pathology review

    Measure Description

    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

    Time Frame

    Up to approximately 6 months after first dose

    Primary Outcome Measures table for Clinical Trial
    Secondary Outcome Measures:
    Outcome Measure

    Part A: Major Pathological Response (MPR) rate per IASLC guidelines as assessed by central pathology review

    Measure Description

    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.

    Time Frame

    Up to approximately 6 months after first dose

    Outcome Measure

    Part A: pCR rate per IASLC guidelines as assessed by investigator

    Measure Description

    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.

    Time Frame

    Up to approximately 6 months after first dose

    Outcome Measure

    Part A: MPR rate per IASLC guidelines as assessed by investigator

    Measure Description

    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.

    Time Frame

    Up to approximately 6 months after first dose

    Outcome Measure

    Part A: Event Free Survival (EFS) per RECIST v1.1 as assessed by investigator

    Measure Description

    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.

    Time Frame

    Up to approximately 5 years

    Outcome Measure

    Part A: Objective Response Rate (ORR) per RECIST v1.1 as assessed by investigator at the completion of neoadjuvant therapy, prior to surgery

    Measure Description

    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.

    Time Frame

    Up to approximately 5 years

    Outcome Measure

    Part B: Disease Free Survival (DFS) per RECIST v1.1 as assessed by investigator

    Measure Description

    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

    Time Frame

    Up to approximately 5 years

    Outcome Measure

    Part C: Confirmed ORR per RECIST v1.1 as assessed by investigator

    Measure Description

    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.

    Time Frame

    Up to approximately 5 years

    Outcome Measure

    Part C: Progression Free Survival (PFS) per RECIST v1.1 as assessed by investigator

    Measure Description

    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

    Time Frame

    Up to approximately 5 years

    Outcome Measure

    Overall Survival (OS)

    Measure Description

    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.

    Time Frame

    Up to approximately 5 years

    Outcome Measure

    Rate of circulating tumor DNA (ctDNA) reduction or clearance

    Measure Description

    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.

    Time Frame

    Part A: Up to 18 months, Part B and Part C: Up to 37 days after the last dose of treatment

    Outcome Measure

    Number of participants with Laboratory abnormalities

    Measure Description

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0).

    Time Frame

    Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

    Outcome Measure

    Pharmacokinetics: Serum concentrations of PF-086344

    Measure Description

    Time Frame

    Up to 37 days after the last dose of treatment, prior to surgery

    Outcome Measure

    Incidence of antidrug antibody against PF-08634404

    Measure Description

    Time Frame

    Up to 37 days after the last dose of treatment, prior to surgery

    Secondary Outcome Measures table for Clinical Trial
    Number of participants

    120

    Collaborators and investigators

    Sponsor: Pfizer

    Collaborator: None

    This information is current as of August 17th 2026.

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    For more information, call or email the Pfizer Clinical Trial Contact Center:

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    When calling, please reference this study number:

    More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT07489066