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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523522-41-00 | EU Trial (CTIS) Number | ||
| Symbiotic-Lung-04 | Other Identifier | Pfizer |
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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:
The study has two parts:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2 Single arm | Experimental | Participants will receive PF-08634404 in combination with chemotherapy |
|
| Phase 3 Experimental Arm | Experimental | Participants will receive PF-08634404 in combination with chemotherapy |
|
| Phase3 Control Arm | Active Comparator | Participants will receive atezolizumab in combination with chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08634404 | Drug | Concentrate for solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator. | Up to approximately 2 years after completion of study treatment of last study participant |
| Phase 2: Number of participants with treatment-emergent adverse events | Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention. | Up to 90 days after the last dose of treatment |
| Phase 3: Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death due to any cause. OS is secondary outcome measure in Phase 2 portion of the study. | Up to approximately 2 years after completion of study treatment of last study participant |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1 | DOR is defined as the time from the first documentation of objective response (CR or PR) to the date of first documentation of progressive disease (PD) or death due to any cause. | Up to approximately 2 years after completion of study treatment of last study participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Recruiting | Fayetteville | Arkansas | 72703 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Phase 2 is open-label, whereas Phase 3 is double-blind, randomized design.
| Atezolizumab | Biological | Injection for intravenous use |
|
| Chemotherapy | Drug | Injection for intravenous use |
|
| Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1 | PFS is defined as the time from the date of randomization to the date of first documented disease progression, per RECIST v1.1, or death to any cause, whichever occurs first | Up to approximately 2 years after completion of study treatment of last study participant |
| Number of participants with Laboratory abnormalities | Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. | Up to 90 days after the last dose of treatment |
| Phase 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT) | DLT (any of the prespecified AEs that are attributable to study treatment(s), excluding toxicities clearly due to underlying disease or extraneous causes) rate estimated based on data from DLT-evaluable participants during the DLT evaluation period. | Up to 90 days after the last dose of treatment |
| Pharmacokinetics: Serum concentrations of PF-08634404 | Up to 37 days after the last dose of treatment |
| Incidence of antidrug antibody against PF-08634404 | Up to 37 days after the last dose of treatment |
| Phase 2: Overall Survival | Overall survival defined as the time from the date of randomization to the date of death due to any cause. | Up to approximately 2 years after completion of study treatment of last study participant |
| Phase 3: PFS using RECIST v1.1 as assessed by blinded independent central review (BICR) | Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by BICR per RECIST v1.1, or death due to any cause, whichever occurs first. | Up to approximately 2 years after completion of study treatment of last study participant |
| Phase 3: Confirmed ORR using RECIST v1.1 as assessed by BICR | ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by BICR. | Up to approximately 2 years after completion of study treatment of last study participant |
| Phase 3: DOR using RECIST v1.1 as assessed by BICR | The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first. | Up to approximately 2 years after completion of study treatment of last study participant |
| Phase 3: Mean scores and Change from baseline in the global health status/quality of life (QoL), function, and symptom scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials. | Up to approximately 2 years after completion of study treatment of last study participant |
| Phase 3: Mean scores and Change from Baseline on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13) | EORTC QLQ-LC13 is a lung cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire, the EORTC QLQ-C30. | Up to approximately 2 years after completion of study treatment of last study participant |
| Phase 3: Time to definitive deterioration (TTdD) in the global health status/QoL, function, and symptom scores on the EORTC QLQ-C30 | TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery. | Up to approximately 2 years after completion of study treatment of last study participant |
| Phase 3: TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 | TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery. | Up to approximately 2 years after completion of study treatment of last study participant |
| BRCR Coral Springs |
| Recruiting |
| Coral Springs |
| Florida |
| 33065 |
| United States |
| Mid Florida Hematology and Oncology Center | Recruiting | Orange City | Florida | 32763 | United States |
| BRCR Global - Tamarac | Recruiting | Tamarac | Florida | 33321 | United States |
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| Texas Oncology - Gulf Coast | Recruiting | Beaumont | Texas | 77702 | United States |
| Texas Oncology - San Antonio | Recruiting | Fredericksburg | Texas | 78624 | United States |
| Texas Oncology - Gulf Coast | Recruiting | Houston | Texas | 77024 | United States |
| Texas Oncology - Gulf Coast | Recruiting | Houston | Texas | 77054 | United States |
| US Oncology Investigational Product Center (IPC) | Recruiting | Irving | Texas | 75063 | United States |
| Texas Oncology - San Antonio | Recruiting | New Braunfels | Texas | 78130 | United States |
| Texas Oncology - Gulf Coast | Recruiting | Pearland | Texas | 77584 | United States |
| Texas Oncology - San Antonio | Recruiting | San Antonio | Texas | 78217 | United States |
| Texas Oncology - San Antonio | Recruiting | San Antonio | Texas | 78240 | United States |
| Texas Oncology - San Antonio | Recruiting | San Antonio | Texas | 78258 | United States |
| Texas Oncology - Gulf Coast | Recruiting | Sugar Land | Texas | 77479 | United States |
| Texas Oncology -Sugar Land | Recruiting | Sugar Land | Texas | 77479 | United States |
| Texas Oncology - Gulf Coast | Recruiting | The Woodlands | Texas | 77380 | United States |
| Texas Oncology - Gulf Coast | Recruiting | Webster | Texas | 77598 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Recruiting | Blacksburg | Virginia | 24060 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Recruiting | Low Moor | Virginia | 24457 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Recruiting | Roanoke | Virginia | 24014 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Recruiting | Salem | Virginia | 24153 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Recruiting | Wytheville | Virginia | 24382 | United States |
| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
| Sunshine Coast University Hospital | Recruiting | Birtinya | Queensland | 4575 | Australia |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510180 | China |
| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| Gustave Roussy | Not yet recruiting | Villejuif | 94805 | France |
| Hôpital Ambroise Paré | Recruiting | Boulogne-Billancourt | Île-de-France Region | 92100 | France |
| Marien Hospital Düsseldorf | Not yet recruiting | Düsseldorf | 40479 | Germany |
| Centro di Riferimento Oncologico (CRO) IRCCS | Not yet recruiting | Aviano | Pordenone | 33081 | Italy |
| IRCCS Istituto Nazionale dei Tumori Regina Elena | Recruiting | Roma | ROME | 00144 | Italy |
| Kansai Medical University Hospital | Recruiting | Hirakata | Osaka | 573-1191 | Japan |
| Shizuoka Cancer Center | Recruiting | Nagaizumi-cho | Shizuoka | 411-8777 | Japan |
| Doctor's Center Hematology & Oncology Group | Recruiting | Manati | 00674 | Puerto Rico |
| Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center | Recruiting | Mayagüez | 00680 | Puerto Rico |
| Pan American Center for Oncology Trials, LLC | Recruiting | San Juan | 00909 | Puerto Rico |
| Hospital Oncologico Dr. Isaac Gonzalez-Martinez | Recruiting | San Juan | 00935 | Puerto Rico |
| HT Médica Jaen LAs Nieves | Not yet recruiting | Jaén | Andalusia | 23007 | Spain |
| Hospital Jerez de la Frontera | Not yet recruiting | Jerez de la Frontera | Cádiz | 11407 | Spain |
| Hospital Universitario 12 de Octubre | Not yet recruiting | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Parc de Salut Mar - Hospital del Mar | Recruiting | Barcelona | 08003 | Spain |
| CETIR | Recruiting | Barcelona | 08029 | Spain |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario de Jaen | Not yet recruiting | Jaén | 23007 | Spain |
| National Cheng Kung University Hospital | Recruiting | Tainan | 704302 | Taiwan |
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
| Taipei Medical University Hospital | Recruiting | Taipei | 110 | Taiwan |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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