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
Purpose
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.
Condition
- Small Cell Lung Cancer (SCLC)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Phase 2 is open-label, whereas Phase 3 is double-blind, randomized design.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 2 Single arm |
Participants will receive PF-08634404 in combination with chemotherapy |
|
|
Experimental Phase 3 Experimental Arm |
Participants will receive PF-08634404 in combination with chemotherapy |
|
|
Active Comparator Phase3 Control Arm |
Participants will receive atezolizumab in combination with chemotherapy |
|
Recruiting Locations
Fayetteville, Arkansas 72703
Rogers, Arkansas 72758
Springdale, Arkansas 72762
Coral Springs, Florida 33065
Orange City, Florida 32763
Tamarac, Florida 33321
Beaumont, Texas 77702
Fredericksburg, Texas 78624
Houston, Texas 77024
Houston, Texas 77054
Irving, Texas 75063
Irving, Texas 75063
New Braunfels, Texas 78130
Pearland, Texas 77584
San Antonio, Texas 78217
San Antonio, Texas 78240
San Antonio, Texas 78258
Sugar Land, Texas 77479
The Woodlands, Texas 77380
Webster, Texas 77598
Blacksburg, Virginia 24060
Chesapeake, Virginia 23320
Hampton, Virginia 23666
Low Moor, Virginia 24457
Newport News, Virginia 23606
Norfolk, Virginia 23502
Roanoke, Virginia 24014
Salem, Virginia 24153
Virginia Beach, Virginia 23456
Williamsburg, Virginia 23188
Wytheville, Virginia 24382
Manati, Puerto Rico 00674
Mayagüez, Puerto Rico 00680
San Juan, Puerto Rico 00909
San Juan, Puerto Rico 00935
More Details
- Status
- Recruiting
- Sponsor
- Pfizer