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Recruiting Phase 2/3 NCT07226999

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

Phase 2/3 – combined trial
Conditions: Small Cell Lung Cancer (SCLC)

Sponsor: Pfizer

trial.available_in: БГ
Overview
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 participate
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
Interventions
PF-08634404
DRUG
Atezolizumab
BIOLOGICAL
Chemotherapy
DRUG
Locations 32
Australia (1)
Border Medical Oncology Research Unit
Albury , New South Wales
NOT_YET_RECRUITING
France (1)
Hôpital Ambroise Paré
Boulogne-Billancourt , Île-de-France Region
NOT_YET_RECRUITING
Japan (2)
Kansai Medical University Hospital
Hirakata , Osaka
Shizuoka Cancer Center
Nagaizumi-cho , Shizuoka
Puerto Rico (4)
Doctor's Center Hematology & Oncology Group
Manati
Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center
Mayagüez
Pan American Center for Oncology Trials, LLC
San Juan
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
San Juan
Spain (1)
Hospital Universitario 12 de Octubre
Madrid , Madrid, Comunidad de
NOT_YET_RECRUITING
Taiwan (3)
National Cheng Kung University Hospital
Tainan
NOT_YET_RECRUITING
National Taiwan University Hospital
Taipei
NOT_YET_RECRUITING
Taipei Medical University Hospital
Taipei
United States (20)
Texas Oncology - Gulf Coast
Beaumont , Texas
BRCR Coral Springs
Coral Springs , Florida
BRCR Global - Coral Springs
Coral Springs , Florida
Highlands Oncology Group
Fayetteville , Arkansas
Texas Oncology - San Antonio
Fredericksburg , Texas
Texas Oncology - Gulf Coast
Houston , Texas
Texas Oncology - Gulf Coast
Houston , Texas
Texas Oncology - San Antonio
New Braunfels , Texas
Mid Florida Hematology and Oncology Center
Orange City , Florida
Texas Oncology - Gulf Coast
Pearland , Texas
Clario
Philadelphia , Pennsylvania
NOT_YET_RECRUITING
Highlands Oncology Group
Rogers , Arkansas
Texas Oncology - San Antonio
San Antonio , Texas
Texas Oncology - San Antonio
San Antonio , Texas
Texas Oncology - San Antonio
San Antonio , Texas
Highlands Oncology Group
Springdale , Arkansas
Texas Oncology - Gulf Coast
Sugar Land , Texas
BRCR Global - Tamarac
Tamarac , Florida
Texas Oncology - Gulf Coast
The Woodlands , Texas
Texas Oncology - Gulf Coast
Webster , Texas
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
09.12.2025
Completion date
11.03.2034
Registry ID
NCT07226999
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.