PF-08634404 plus chemotherapy for extensive-stage small cell lung cancer
Official title: A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
Run by Pfizer · NCT07226999 · Data updated 2026-11-12
This study will try adding PF-08634404 to chemotherapy in adults with extensive-stage small cell lung cancer to see if it works better than current first-line treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 550 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | chemotherapy, atezolizumab, radiation |
| Locations | 82 sites (Fayetteville, Arkansas and 81 other locations) |
| Status | Recruiting |
| Started | December 9, 2025 |
| Main results expected | June 14, 2030 |
| Study ends | March 11, 2034 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07226999 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with lab-confirmed extensive-stage small cell lung cancer who have not received prior systemic treatment for ES-SCLC, have ECOG 0–1, measurable disease, and adequate organ function are ideal candidates.
✕Probably not a fit
Patients with active central nervous system metastases, leptomeningeal disease, recent other malignancies, active autoimmune disease needing systemic treatment, poor organ function, or ECOG >1 are unlikely to qualify or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial enrolls adults with newly diagnosed extensive-stage small cell lung cancer and gives PF-08634404 together with standard chemotherapy by IV. It has an initial safety/tolerability phase to determine how the medicine is handled with chemotherapy, followed by a randomized phase comparing PF-08634404 plus chemotherapy to the approved combination of atezolizumab plus chemotherapy. Participants must have measurable disease, good performance status (ECOG 0–1), and adequate organ function; treatments and follow-up visits occur at participating clinic sites. Outcomes include safety, tolerability, and comparative clinical outcomes such as tumor response and disease control.
Why it matters
Potential benefit: If successful, adding PF-08634404 to chemotherapy could improve response rates or survival compared with current first-line therapy.
How similar studies have gone: Previous trials adding immunotherapy to chemotherapy (for example atezolizumab) have modestly improved outcomes in first-line ES-SCLC, but PF-08634404 is a new agent with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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Highlands Oncology Group
Fayetteville, Arkansas, United States Recruiting -
Highlands Oncology Group
Rogers, Arkansas, United States Recruiting -
Highlands Oncology Group
Springdale, Arkansas, United States Recruiting -
BRCR Coral Springs
Coral Springs, Florida, United States Recruiting -
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States Recruiting -
BRCR Global - Tamarac
Tamarac, Florida, United States Recruiting
Show 44 more locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Recruiting -
Texas Oncology - Northeast Texas
Allen, Texas, United States Recruiting -
Texas Oncology - DFW
Arlington, Texas, United States Recruiting -
Texas Oncology - DFW
Arlington, Texas, United States Recruiting -
Texas Oncology - Gulf Coast
Beaumont, Texas, United States Recruiting -
Texas Oncology - DFW
Bedford, Texas, United States Recruiting -
Texas Oncology - DFW
Dallas, Texas, United States Recruiting -
Texas Oncology - DFW
Dallas, Texas, United States Recruiting -
Texas Oncology - DFW
Dallas, Texas, United States Recruiting -
Texas Oncology - DFW
Dallas, Texas, United States Recruiting -
Texas Oncology - DFW
Dallas, Texas, United States Recruiting -
Texas Oncology - Northeast Texas
Denison, Texas, United States Recruiting -
Texas Oncology - Northeast Texas
Denton, Texas, United States Recruiting -
Texas Oncology - Northeast Texas
Flower Mound, Texas, United States Recruiting -
Texas Oncology - DFW
Fort Worth, Texas, United States Recruiting -
Texas Oncology - San Antonio
Fredericksburg, Texas, United States Recruiting -
Texas Oncology - DFW
Grapevine, Texas, United States Recruiting -
Texas Oncology - Gulf Coast
Houston, Texas, United States Recruiting -
Texas Oncology - Gulf Coast
Houston, Texas, United States Recruiting -
US Oncology Investigational Product Center (IPC)
Irving, Texas, United States Recruiting -
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States Recruiting -
Texas Oncology - Northeast Texas
Lewisville, Texas, United States Recruiting -
Texas Oncology - Northeast Texas
Longview, Texas, United States Recruiting -
Texas Oncology - Northeast Texas
McKinney, Texas, United States Recruiting -
Texas Oncology - San Antonio
New Braunfels, Texas, United States Recruiting -
Texas Oncology - Northeast Texas
Palestine, Texas, United States Recruiting -
Texas Oncology - Northeast Texas
Paris, Texas, United States Recruiting -
Texas Oncology - Gulf Coast
Pearland, Texas, United States Recruiting -
Texas Oncology - DFW
Plano, Texas, United States Recruiting -
Texas Oncology - DFW
Plano, Texas, United States Recruiting -
Texas Oncology - San Antonio
San Antonio, Texas, United States Recruiting -
Texas Oncology - San Antonio
San Antonio, Texas, United States Recruiting -
Texas Oncology - San Antonio
San Antonio, Texas, United States Recruiting -
Texas Oncology - Gulf Coast
Sugar Land, Texas, United States Recruiting -
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States Recruiting -
Texas Oncology - Northeast Texas
Tyler, Texas, United States Recruiting -
Texas Oncology - Gulf Coast
Webster, Texas, United States Recruiting -
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, United States Recruiting -
Virginia Oncology Associates
Chesapeake, Virginia, United States Recruiting -
Virginia Oncology Associates
Hampton, Virginia, United States Recruiting -
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, United States Recruiting -
Virginia Oncology Associates
Newport News, Virginia, United States Recruiting -
Virginia Oncology Associates
Norfolk, Virginia, United States Recruiting -
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States Recruiting
+32 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.