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
Recruiting · NCT07226999 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
60 locations listed across 5 US states.
- 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
- Mid Florida Hematology and Oncology Center - Orange City, Florida, United States
- BRCR Global - Tamarac - Tamarac, Florida, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- Texas Oncology - Northeast Texas - Allen, Texas, United States
- Texas Oncology - DFW - Arlington, Texas, United States
- Texas Oncology - DFW - Arlington, Texas, United States
- Texas Oncology - Gulf Coast - Beaumont, Texas, United States
- Texas Oncology - DFW - Bedford, Texas, United States
- Texas Oncology - DFW - Dallas, Texas, United States
- Texas Oncology - DFW - Dallas, Texas, United States
- Texas Oncology - DFW - Dallas, Texas, United States
- Texas Oncology - DFW - Dallas, Texas, United States
- Texas Oncology - DFW - Dallas, Texas, United States
- Texas Oncology - Northeast Texas - Denison, Texas, United States
- Texas Oncology - Northeast Texas - Denton, Texas, United States
- Texas Oncology - Northeast Texas - Flower Mound, Texas, United States
- Texas Oncology - DFW - Fort Worth, Texas, United States
- Texas Oncology - San Antonio - Fredericksburg, Texas, United States
- Texas Oncology - DFW - Grapevine, Texas, United States
- Texas Oncology - Gulf Coast - Houston, Texas, United States
- Texas Oncology - Gulf Coast - Houston, Texas, United States
- US Oncology Investigational Product Center (IPC) - Irving, Texas, United States
- US Oncology Investigational Products Center (IPC) - Irving, Texas, United States
- US Oncology Investigational Products Center (IPC) - Irving, Texas, United States
- Texas Oncology - Northeast Texas - Lewisville, Texas, United States
- Texas Oncology - Northeast Texas - Longview, Texas, United States
- Texas Oncology - Northeast Texas - McKinney, Texas, United States
- Texas Oncology - San Antonio - New Braunfels, Texas, United States
- Texas Oncology - Northeast Texas - Palestine, Texas, United States
- Texas Oncology - Northeast Texas - Paris, Texas, United States
- Texas Oncology - Gulf Coast - Pearland, Texas, United States
- Texas Oncology - DFW - Plano, Texas, United States
- Texas Oncology - DFW - Plano, 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 - Northeast Texas - Tyler, Texas, United States
- Texas Oncology - Gulf Coast - Webster, Texas, United States
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Blacksburg, Virginia, United States
- Virginia Oncology Associates - Chesapeake, Virginia, United States
- Virginia Oncology Associates - Hampton, Virginia, United States
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Low Moor, Virginia, United States
- Virginia Oncology Associates - Newport News, Virginia, United States
- Virginia Oncology Associates - Norfolk, Virginia, United States
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke, Virginia, United States
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Salem, Virginia, United States
- Virginia Oncology Associates - Virginia Beach, Virginia, United States
- Virginia Oncology Associates - Williamsburg, Virginia, United States
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Wytheville, Virginia, United States
- Parc de Salut Mar - Hospital del Mar - Barcelona, Spain
- CETIR - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Marien Hospital Düsseldorf - Düsseldorf, Germany
- Krankenhaus Nordwest GmbH - Frankfurt am Main, Germany
Showing 60 of 83 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →