RecruitingPhase 2Phase 3NCT07226999

Symbiotic-Lung-04: 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

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called PF-08634404 combined with standard chemotherapy as a first-line treatment for people with extensive-stage small cell lung cancer (a fast-growing type of lung cancer that has spread beyond the chest). **You may be eligible if...** - You have been confirmed to have extensive-stage small cell lung cancer - You have not yet received any systemic treatment (chemotherapy or radiation) for this stage of disease - You have at least one measurable tumor - Your general health is good (ECOG status 0 or 1) - Your organ function is adequate **You may NOT be eligible if...** - You have known active cancer spread to the brain, spinal cord, or brain lining - You have a significant risk of bleeding or abnormal connections between organs - You have had another cancer within the past 3 years - You have had an active autoimmune disease requiring treatment in the past 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPF-08634404

Concentrate for solution for infusion

BIOLOGICALAtezolizumab

Injection for intravenous use

DRUGChemotherapy

Injection for intravenous use


Locations(32)

Highlands Oncology Group

Fayetteville, Arkansas, United States

Highlands Oncology Group

Rogers, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

BRCR Coral Springs

Coral Springs, Florida, United States

BRCR Global - Coral Springs

Coral Springs, Florida, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

BRCR Global - Tamarac

Tamarac, Florida, United States

Clario

Philadelphia, Pennsylvania, United States

Texas Oncology - Gulf Coast

Beaumont, Texas, United States

Texas Oncology - San Antonio

Fredericksburg, Texas, United States

Texas Oncology - Gulf Coast

Houston, Texas, United States

Texas Oncology - Gulf Coast

Houston, Texas, United States

Texas Oncology - San Antonio

New Braunfels, Texas, United States

Texas Oncology - Gulf Coast

Pearland, Texas, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

Texas Oncology - Gulf Coast

Sugar Land, Texas, United States

Texas Oncology - Gulf Coast

The Woodlands, Texas, United States

Texas Oncology - Gulf Coast

Webster, Texas, United States

Border Medical Oncology Research Unit

Albury, New South Wales, Australia

Hôpital Ambroise Paré

Boulogne-Billancourt, Île-de-France Region, France

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan

Doctor's Center Hematology & Oncology Group

Manati, Puerto Rico

Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center

Mayagüez, Puerto Rico

Pan American Center for Oncology Trials, LLC

San Juan, Puerto Rico

Hospital Oncologico Dr. Isaac Gonzalez-Martinez

San Juan, Puerto Rico

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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