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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

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

ArmDescriptionAssigned Intervention
Experimental
Phase 2 Single arm 		Participants will receive PF-08634404 in combination with chemotherapy
  • Drug: PF-08634404
    Concentrate for solution for infusion
  • Drug: Chemotherapy
    Injection for intravenous use
Experimental
Phase 3 Experimental Arm 		Participants will receive PF-08634404 in combination with chemotherapy
  • Drug: PF-08634404
    Concentrate for solution for infusion
  • Drug: Chemotherapy
    Injection for intravenous use
Active Comparator
Phase3 Control Arm 		Participants will receive atezolizumab in combination with chemotherapy
  • Biological: Atezolizumab
    Injection for intravenous use
  • Drug: Chemotherapy
    Injection for intravenous use

Recruiting Locations

Highlands Oncology Group
Fayetteville, Arkansas 72703

Highlands Oncology Group
Rogers, Arkansas 72758

Highlands Oncology Group
Springdale, Arkansas 72762

BRCR Coral Springs
Coral Springs, Florida 33065

Mid Florida Hematology and Oncology Center
Orange City, Florida 32763

BRCR Global - Tamarac
Tamarac, Florida 33321

Texas Oncology - Gulf Coast
Beaumont, Texas 77702

Texas Oncology - San Antonio
Fredericksburg, Texas 78624

Texas Oncology - Gulf Coast
Houston, Texas 77024

Texas Oncology - Gulf Coast
Houston, Texas 77054

US Oncology Investigational Product Center (IPC)
Irving, Texas 75063

US Oncology Investigational Products Center (IPC)
Irving, Texas 75063

Texas Oncology - San Antonio
New Braunfels, Texas 78130

Texas Oncology - Gulf Coast
Pearland, Texas 77584

Texas Oncology - San Antonio
San Antonio, Texas 78217

Texas Oncology - San Antonio
San Antonio, Texas 78240

Texas Oncology - San Antonio
San Antonio, Texas 78258

Texas Oncology - Gulf Coast
Sugar Land, Texas 77479

Texas Oncology - Gulf Coast
The Woodlands, Texas 77380

Texas Oncology - Gulf Coast
Webster, Texas 77598

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia 24060

Virginia Oncology Associates
Chesapeake, Virginia 23320

Virginia Oncology Associates
Hampton, Virginia 23666

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia 24457

Virginia Oncology Associates
Newport News, Virginia 23606

Virginia Oncology Associates
Norfolk, Virginia 23502

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia 24014

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia 24153

Virginia Oncology Associates
Virginia Beach, Virginia 23456

Virginia Oncology Associates
Williamsburg, Virginia 23188

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia 24382

Doctor's Center Hematology & Oncology Group
Manati, Puerto Rico 00674

Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center
Mayagüez, Puerto Rico 00680

Pan American Center for Oncology Trials, LLC
San Juan, Puerto Rico 00909

Hospital Oncologico Dr. Isaac Gonzalez-Martinez
San Juan, Puerto Rico 00935

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.