RecruitingPhase 2Phase 3NCT07226999

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer

A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER


Sponsor

Pfizer

Enrollment

550 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Summary

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have extensive-stage small cell lung cancer confirmed by lab tests. * Have not received chemotherapy or radiation for this type of lung cancer. * Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better. Participants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
  • Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.
  • Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
  • Have at least one measurable lesion as the targeted lesion based on RECIST V1.1.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Adequate organ function

Exclusion Criteria5

  • known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
  • Leptomeningeal disease
  • Clinically significant risk of hemorrhage or fistula
  • history of another malignancy within 3 years
  • active autoimmune diseases requiring systemic treatment within the past 2 years

Interventions

DRUGPF-08634404

Concentrate for solution for infusion

BIOLOGICALAtezolizumab

Injection for intravenous use

DRUGChemotherapy

Injection for intravenous use


Locations(6)

Highlands Oncology Group

Springdale, Arkansas, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

Texas Oncology - Gulf Coast

Webster, Texas, United States

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Pan American Center for Oncology Trials, LLC

San Juan, Other, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT07226999