RecruitingRecruiting
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
NCT07226999 · Pfizer
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
About this study
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 criteria
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
Enrollment target: 550 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-12-09
Estimated completion: 2034-03-11
Last updated: 2026-08-17
Interventions
Drug: PF-08634404Biological: AtezolizumabDrug: Chemotherapy
Primary outcomes
- • Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment (Up to approximately 2 years after completion of study treatment of last study participant)
- • Phase 2: Number of participants with treatment-emergent adverse events (Up to 90 days after the last dose of treatment)
- • Phase 3: Overall Survival (OS) (Up to approximately 2 years after completion of study treatment of last study participant)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (83)
Highlands Oncology GroupRecruiting
Fayetteville, Arkansas, United States
Highlands Oncology GroupRecruiting
Rogers, Arkansas, United States
Highlands Oncology GroupRecruiting
Springdale, Arkansas, United States
BRCR Coral SpringsRecruiting
Coral Springs, Florida, United States
Mid Florida Hematology and Oncology CenterRecruiting
Orange City, Florida, United States
BRCR Global - TamaracRecruiting
Tamarac, Florida, United States
University Hospitals Cleveland Medical CenterNot Yet Recruiting
Cleveland, Ohio, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
Allen, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Arlington, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Arlington, Texas, United States
Texas Oncology - Gulf CoastRecruiting
Beaumont, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Bedford, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Dallas, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Dallas, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Dallas, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Dallas, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Dallas, Texas, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
Denison, Texas, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
Denton, Texas, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
Flower Mound, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Fort Worth, Texas, United States
Texas Oncology - San AntonioRecruiting
Fredericksburg, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Grapevine, Texas, United States
Texas Oncology - Gulf CoastRecruiting
Houston, Texas, United States
Texas Oncology - Gulf CoastRecruiting
Houston, Texas, United States
US Oncology Investigational Product Center (IPC)Recruiting
Irving, Texas, United States
US Oncology Investigational Products Center (IPC)Recruiting
Irving, Texas, United States
US Oncology Investigational Products Center (IPC)Not Yet Recruiting
Irving, Texas, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
Lewisville, Texas, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
Longview, Texas, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
McKinney, Texas, United States
Texas Oncology - San AntonioRecruiting
New Braunfels, Texas, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
Palestine, Texas, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
Paris, Texas, United States
Texas Oncology - Gulf CoastRecruiting
Pearland, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Plano, Texas, United States
Texas Oncology - DFWNot Yet Recruiting
Plano, Texas, United States
Texas Oncology - San AntonioRecruiting
San Antonio, Texas, United States
Texas Oncology - San AntonioRecruiting
San Antonio, Texas, United States
Texas Oncology - San AntonioRecruiting
San Antonio, Texas, United States
Texas Oncology - Gulf CoastRecruiting
Sugar Land, Texas, United States
Texas Oncology - Gulf CoastRecruiting
The Woodlands, Texas, United States
Texas Oncology - Northeast TexasNot Yet Recruiting
Tyler, Texas, United States
Texas Oncology - Gulf CoastRecruiting
Webster, Texas, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareRecruiting
Blacksburg, Virginia, United States
Virginia Oncology AssociatesRecruiting
Chesapeake, Virginia, United States
Virginia Oncology AssociatesRecruiting
Hampton, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareRecruiting
Low Moor, Virginia, United States
Virginia Oncology AssociatesRecruiting
Newport News, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareRecruiting
Roanoke, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareRecruiting
Salem, Virginia, United States
Virginia Oncology AssociatesRecruiting
Virginia Beach, Virginia, United States
Virginia Oncology AssociatesRecruiting
Williamsburg, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareRecruiting
Wytheville, Virginia, United States
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Sunshine Coast University HospitalRecruiting
Birtinya, Queensland, Australia
Guangdong Provincial People's HospitalRecruiting
Guangzhou, Guangdong, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, Shanghai Municipality, China
Gustave RoussyRecruiting
Villejuif, France
Hôpital Ambroise ParéRecruiting
Boulogne-Billancourt, Île-de-France Region, France
Marien Hospital DüsseldorfRecruiting
Düsseldorf, Germany
Krankenhaus Nordwest GmbHRecruiting
Frankfurt am Main, Germany
Centro di Riferimento Oncologico (CRO) IRCCSRecruiting
Aviano, Pordenone, Italy
IRCCS Istituto Nazionale dei Tumori Regina ElenaRecruiting
Roma, ROME, Italy
Azienda Ospedaliero-Universitaria San Luigi GonzagaRecruiting
Orbassano, Turin, Italy
Kansai Medical University HospitalRecruiting
Hirakata, Osaka, Japan
Shizuoka Cancer CenterRecruiting
Nagaizumi-cho, Shizuoka, Japan
Japanese Foundation for Cancer ResearchRecruiting
Kotoku, Tokyo, Japan
Doctor's Center Hematology & Oncology GroupRecruiting
Manati, Puerto Rico
Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical CenterRecruiting
Mayagüez, Puerto Rico
Pan American Center for Oncology Trials LLCRecruiting
San Juan, Puerto Rico
Hospital Oncologico Dr. Isaac Gonzalez-MartinezRecruiting
San Juan, Puerto Rico
HT Médica Jaen LAs NievesRecruiting
Jaén, Andalusia, Spain
Hospital Jerez de la FronteraRecruiting
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Madrid, Comunidad de, Spain
Parc de Salut Mar - Hospital del MarRecruiting
Barcelona, Spain
CETIRRecruiting
Barcelona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Universitario de JaenRecruiting
Jaén, Spain
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Medical University HospitalRecruiting
Taipei, Taiwan