Clinical trial Recruiting at 82 sites Phase2; Phase3 Interventional Ages 18 and up

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.

More Small Cell Lung Cancer ( SCLC ) trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment550 (estimated)
SponsorPfizer
Industry-sponsored
Drugs / interventionschemotherapy, atezolizumab, radiation
Locations82 sites (Fayetteville, Arkansas and 81 other locations)
StatusRecruiting
StartedDecember 9, 2025
Main results expectedJune 14, 2030
Study endsMarch 11, 2034
Registry record updatedOctober 8, 2026
Trial IDNCT07226999 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

  • 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
  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.