Study on PF-08634404 with Chemotherapy for Adults with Extensive-Stage Small Cell Lung Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT07226999
This clinical trial is exploring a new medicine, PF-08634404, combined with chemotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC), a type of lung cancer that spreads quickly.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to learn more about a new medicine called PF-08634404 and how well it works when combined with chemotherapy in treating adults with extensive-stage small cell lung cancer (ES-SCLC). This type of lung cancer grows rapidly and spreads widely in the body. The study is divided into two parts: the first part will assess the safety and tolerance of the new medicine with chemotherapy, and the second part will compare this combination to another approved treatment (atezolizumab plus chemotherapy) to see which is more effective. Participants will receive the treatment through IV infusions, which are given directly into a vein, in cycles. Some participants may continue receiving the study medicine alone after the initial treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) based on lab tests.
- Have not received chemotherapy or radiation for this type of lung cancer.
- Have not had any chemotherapy or radiation for at least 6 months if previously treated for limited-stage SCLC.
- Have at least one measurable tumor that can be tracked using standard criteria.
- Be in good physical condition with a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have healthy organs based on medical tests.
Exclusion Criteria
- Have active cancer spread to the brain, brainstem, or spinal cord.
- Have leptomeningeal disease (cancer spread to the membranes surrounding the brain and spinal cord).
- Have a significant risk of bleeding or abnormal connections between organs.
- Have had another type of cancer within the past 3 years.
- Have active autoimmune diseases that required treatment in the past 2 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Mid Florida Hematology and Oncology Center | 32763 | Orange City | Florida |
| Texas Oncology - San Antonio | 78130 | San Antonio | Texas |
| Texas Oncology - Gulf Coast | 77598 | Webster | Texas |
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