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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

NCT07226999

RecruitingPhase 2, Phase 3

Sponsor: Pfizer

Conditions: Small Cell Lung Cancer (SCLC)

Interventions: PF-08634404, Atezolizumab, Chemotherapy

Countries: United States, Australia, China, France, Germany, Italy, Japan, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (73)

Fayetteville, Arkansas, United States
Rogers, Arkansas, United States
Springdale, Arkansas, United States
Coral Springs, Florida, United States
Orange City, Florida, United States
Tamarac, Florida, United States
Cleveland, Ohio, United States
Arlington, Texas, United States
Arlington, Texas, United States
Beaumont, Texas, United States
Bedford, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Fredericksburg, Texas, United States
Grapevine, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Irving, Texas, United States
Irving, Texas, United States
New Braunfels, Texas, United States
Pearland, Texas, United States
Plano, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
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