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A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
Florida
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Texas
Texas Oncology - San Antonio
RECRUITING
San Antonio
Texas Oncology - Gulf Coast
RECRUITING
Webster
Other Locations
Japan
Kansai Medical University Hospital
RECRUITING
Hirakata
Puerto Rico
Pan American Center for Oncology Trials, LLC
RECRUITING
San Juan
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-12-09
Estimated Completion Date: 2034-03-11
Participants
Target number of participants: 550
Treatments
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
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov