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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

Gastrointestinal Cancer

Category

Genitourinary Cancer

Category

Thoracic Cancer

PD-1 x VEGF Bispecific Antibody

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

A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER

Phase 2

NCT07476287

Active enrolling

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Locations

United States, China, Israel, Japan, Taiwan

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Study design
Participant Group/Arm

EXPERIMENTAL: PF-08634404

Participants will receive PF-08634404 in combination with chemotherapy intravenously, followed by maintenance therapy with PF-08634404.

Intervention/Treatment

DRUG: PF-08634404

Concentrate for solution for infusion

DRUG: Chemotherapy

Injection for intravenous use
Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
  • Male or female participants aged ≥18 years at the time of informed consent.
  • Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).
  • Participants have not received systemic therapy for T-SCLC.
  • Have at least one measurable lesion as the target lesion based on RECIST v1.1.
  • Have sufficient tumor tissue from the diagnosis of transformed SCLC available.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have a minimum life expectancy of \>12 weeks.
  • Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
  • Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \<1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.
  • Leptomeningeal disease
  • Clinically significant risk of hemorrhage or fistula, including tumor necrosis/cavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula
  • History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)
  • Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)
  • History of allogeneic organ or hematopoietic stem cell transplantation
  • Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)
  • Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:
    • Prior or current non-infectious pneumonitis requiring systemic therapy
    • DLCO \<50% predicted
    • Severe asthma, COPD, pulmonary embolism, or autoimmune lung involveme
  • Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose
  • Baseline QTcF \>480 msec
  • Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study
  • Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage
  • History of significant bleeding disorders or recent major bleeding events
  • Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding
  • Active, uncontrolled, or symptomatic infection, including:
    • Active TB
    • Active hepatitis B or C
    • Uncontrolled HIV infecti
  • History of immunodeficiency
  • Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies
  • Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation
  • Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods
  • Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes
  • Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)
  • Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements
    • Key dates
    Study start date
    • May 2026
    Estimated Study Completion Date
    • March 2031
    Key endpoints
    Primary Outcome Measures
    Outcome Measure

    Confirmed Objective Response Rate (ORR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Measure Description

    Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator.

    Time Frame

    From start of treatment until first documented CR or PR (approximately maximum up to 1 years)

    Outcome Measure

    Number of Participants with Adverse Events (AEs)

    Measure Description

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

    Time Frame

    Up to 90 days after the last dose of treatment

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

    Duration of Response (DOR) as assessed by investigator based on RECIST v1.1

    Measure Description

    DOR is defined as the time from the first documentation of objective response (CR or PR) to the date of first documentation of disease progression (PD) or death due to any cause.

    Time Frame

    Up to approximately 2 years after completion of study treatment of last study participant

    Outcome Measure

    Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1

    Measure Description

    PFS is defined as the time from the date of randomization to the date of first documented disease progression, per RECIST v1.1, or death to any cause, whichever occurs first

    Time Frame

    Up to approximately 2 years after completion of study treatment of last study participant

    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 2 years after completion of study treatment of last study participant

    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), and timing.

    Time Frame

    Up to 90 days after the last dose of treatment

    Outcome Measure

    Pharmacokinetics: Predose and postdose Serum concentrations of PF-08634404

    Measure Description

    Time Frame

    Up to 37 days after the last dose of treatment

    Outcome Measure

    Incidence of antidrug antibody against PF-08634404

    Measure Description

    Time Frame

    Up to 37 days after the last dose of treatment

    Secondary Outcome Measures table for Clinical Trial
    Number of participants

    40

    Collaborators and investigators

    Sponsor: Pfizer

    Collaborator: None

    This information is current as of June 4th 2026.

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

    1-800-887-7002 Email us

    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. NCT07476287