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 now · Phase 2/Phase 3
Conditions studied: Small Cell Lung Cancer (SCLC)
In brief
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.
Key facts
- Study ID
- NCT07226999
- Run by
- Pfizer
- People needed
- 550
- Starts
- 2025-12-09
- Expected to finish
- 2034-03-11
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Texas Oncology - Gulf Coast — Webster, Texas, United States (enrolling)
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care — Low Moor, Virginia, United States (enrolling)
- Texas Oncology - San Antonio — San Antonio, Texas, United States (enrolling)
- Texas Oncology - Gulf Coast — The Woodlands, Texas, United States (enrolling)
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care — Blacksburg, Virginia, United States (enrolling)
- Virginia Oncology Associates — Hampton, Virginia, United States (enrolling)
- Texas Oncology - San Antonio — San Antonio, Texas, United States (enrolling)
- Texas Oncology - San Antonio — San Antonio, Texas, United States (enrolling)
- Texas Oncology - Gulf Coast — Beaumont, Texas, United States (enrolling)
- Texas Oncology - Gulf Coast — Sugar Land, Texas, United States (enrolling)
- BRCR Global - Tamarac — Tamarac, Florida, United States (enrolling)
- Highlands Oncology Group — Fayetteville, Arkansas, United States (enrolling)
- Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
- Virginia Oncology Associates — Chesapeake, Virginia, United States (enrolling)
- BRCR Coral Springs — Coral Springs, Florida, United States (enrolling)
- Texas Oncology - Gulf Coast — Pearland, Texas, United States (enrolling)
- Texas Oncology - San Antonio — Fredericksburg, Texas, United States (enrolling)
- Highlands Oncology Group — Rogers, Arkansas, United States (enrolling)
- Texas Oncology - Gulf Coast — Houston, Texas, United States (enrolling)
- Texas Oncology - Gulf Coast — Houston, Texas, United States (enrolling)
- US Oncology Investigational Product Center (IPC) — Irving, Texas, United States (enrolling)
- Mid Florida Hematology and Oncology Center — Orange City, Florida, United States (enrolling)
- US Oncology Investigational Products Center (IPC) — Irving, Texas, United States (enrolling)
- Texas Oncology - San Antonio — New Braunfels, Texas, United States (enrolling)
- Virginia Oncology Associates — Newport News, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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