Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combina
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 followin
| Condition(s) | Small Cell Lung Cancer (SCLC) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | 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 |
| 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 wit |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Pfizer |
| Locations | 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 (+37 more sites) |
| Start date | 2025-12-09 |
| NCT ID | NCT07226999 |
| Official listing | https://clinicaltrials.gov/study/NCT07226999 |