- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07226999
Eine Studie zur Untersuchung des Studienmedikaments PF-08634404 in Kombination mit Chemotherapie bei erwachsenen Teilnehmern mit kleinzelligem Lungenkarzinom im extensiven Stadium
EINE GLOBALE INTERVENTIONELLE STUDIE DER PHASE 2/3 VON PF-08634404 IN KOMBINATION MIT CHEMOTHERAPIE BEI TEILNEHMERN MIT EXTENSIVEM KLEINZELLIGEM LUNGENKARZINOM
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studienorte
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New South Wales
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Westmead, New South Wales, Australien, 2145
- Rekrutierung
- Westmead Hospital
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Queensland
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Birtinya, Queensland, Australien, 4575
- Rekrutierung
- Sunshine Coast University Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510180
- Rekrutierung
- Guangdong Provincial People's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
- Rekrutierung
- Fudan University Shanghai Cancer Center
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Düsseldorf, Deutschland, 40479
- Rekrutierung
- Marien Hospital Düsseldorf
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Frankfurt am Main, Deutschland, 60488
- Rekrutierung
- Krankenhaus Nordwest GmbH
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Villejuif, Frankreich, 94805
- Rekrutierung
- Gustave Roussy
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Île-de-France Region
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Boulogne-Billancourt, Île-de-France Region, Frankreich, 92100
- Rekrutierung
- Hôpital Ambroise Paré
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Pordenone
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Aviano, Pordenone, Italien, 33081
- Rekrutierung
- Centro di Riferimento Oncologico (CRO) IRCCS
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ROME
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Roma, ROME, Italien, 00144
- Rekrutierung
- IRCCS Istituto Nazionale dei Tumori Regina Elena
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Turin
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Orbassano, Turin, Italien, 10043
- Rekrutierung
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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Osaka
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Hirakata, Osaka, Japan, 573-1191
- Rekrutierung
- Kansai Medical University Hospital
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Shizuoka
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Nagaizumi-cho, Shizuoka, Japan, 411-8777
- Rekrutierung
- Shizuoka Cancer Center
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Tokyo
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Kotoku, Tokyo, Japan, 135-8550
- Rekrutierung
- Japanese Foundation for Cancer Research
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Manati, Puerto Rico, 00674
- Rekrutierung
- Doctor's Center Hematology & Oncology Group
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Mayagüez, Puerto Rico, 00680
- Rekrutierung
- Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center
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San Juan, Puerto Rico, 00935
- Rekrutierung
- Hospital Oncologico Dr. Isaac Gonzalez-Martinez
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San Juan, Puerto Rico, 00909
- Rekrutierung
- Pan American Center for Oncology Trials LLC
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Barcelona, Spanien, 08035
- Rekrutierung
- Hospital Universitari Vall d'Hebron
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Barcelona, Spanien, 08003
- Rekrutierung
- Parc de Salut Mar - Hospital del Mar
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Barcelona, Spanien, 08029
- Rekrutierung
- CETIR
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Jaén, Spanien, 23007
- Rekrutierung
- Hospital Universitario de Jaen
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Andalusia
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Jaén, Andalusia, Spanien, 23007
- Rekrutierung
- HT Médica Jaen LAs Nieves
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Cádiz
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Jerez de la Frontera, Cádiz, Spanien, 11407
- Rekrutierung
- Hospital Jerez de la Frontera
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spanien, 28041
- Rekrutierung
- Hospital Universitario 12 de Octubre
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Tainan, Taiwan, 704302
- Rekrutierung
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10002
- Rekrutierung
- National Taiwan University Hospital
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Taipei, Taiwan, 110
- Rekrutierung
- Taipei Medical University Hospital
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Arkansas
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Fayetteville, Arkansas, Vereinigte Staaten, 72703
- Rekrutierung
- Highlands Oncology Group
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Rogers, Arkansas, Vereinigte Staaten, 72758
- Rekrutierung
- Highlands Oncology Group
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Springdale, Arkansas, Vereinigte Staaten, 72762
- Rekrutierung
- Highlands Oncology Group
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Florida
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Coral Springs, Florida, Vereinigte Staaten, 33065
- Rekrutierung
- BRCR Coral Springs
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Orange City, Florida, Vereinigte Staaten, 32763
- Rekrutierung
- Mid Florida Hematology and Oncology Center
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Tamarac, Florida, Vereinigte Staaten, 33321
- Rekrutierung
- BRCR Global - Tamarac
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44106
- Rekrutierung
- University Hospitals Cleveland Medical Center
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Texas
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Allen, Texas, Vereinigte Staaten, 75013
- Rekrutierung
- Texas Oncology - Northeast Texas
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Arlington, Texas, Vereinigte Staaten, 76012
- Rekrutierung
- Texas Oncology - DFW
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Arlington, Texas, Vereinigte Staaten, 76014
- Rekrutierung
- Texas Oncology - DFW
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Beaumont, Texas, Vereinigte Staaten, 77702
- Rekrutierung
- Texas Oncology - Gulf Coast
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Bedford, Texas, Vereinigte Staaten, 76022
- Rekrutierung
- Texas Oncology - DFW
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Dallas, Texas, Vereinigte Staaten, 75246
- Rekrutierung
- Texas Oncology - DFW
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Dallas, Texas, Vereinigte Staaten, 75203
- Rekrutierung
- Texas Oncology - DFW
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Dallas, Texas, Vereinigte Staaten, 75230
- Rekrutierung
- Texas Oncology - DFW
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Dallas, Texas, Vereinigte Staaten, 75231
- Rekrutierung
- Texas Oncology - DFW
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Dallas, Texas, Vereinigte Staaten, 75237
- Rekrutierung
- Texas Oncology - DFW
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Denison, Texas, Vereinigte Staaten, 75020
- Rekrutierung
- Texas Oncology - Northeast Texas
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Denton, Texas, Vereinigte Staaten, 76201
- Rekrutierung
- Texas Oncology - Northeast Texas
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Flower Mound, Texas, Vereinigte Staaten, 75028
- Rekrutierung
- Texas Oncology - Northeast Texas
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Fort Worth, Texas, Vereinigte Staaten, 76104
- Rekrutierung
- Texas Oncology - DFW
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Fredericksburg, Texas, Vereinigte Staaten, 78624
- Rekrutierung
- Texas Oncology - San Antonio
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Grapevine, Texas, Vereinigte Staaten, 76051
- Rekrutierung
- Texas Oncology - DFW
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Houston, Texas, Vereinigte Staaten, 77024
- Rekrutierung
- Texas Oncology - Gulf Coast
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Houston, Texas, Vereinigte Staaten, 77054
- Rekrutierung
- Texas Oncology - Gulf Coast
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Irving, Texas, Vereinigte Staaten, 75063
- Rekrutierung
- US Oncology Investigational Products Center (IPC)
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Irving, Texas, Vereinigte Staaten, 75063
- Rekrutierung
- US Oncology Investigational Product Center (IPC)
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Lewisville, Texas, Vereinigte Staaten, 75056
- Rekrutierung
- Texas Oncology - Northeast Texas
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Longview, Texas, Vereinigte Staaten, 75601
- Rekrutierung
- Texas Oncology - Northeast Texas
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McKinney, Texas, Vereinigte Staaten, 75071
- Rekrutierung
- Texas Oncology - Northeast Texas
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New Braunfels, Texas, Vereinigte Staaten, 78130
- Rekrutierung
- Texas Oncology - San Antonio
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Palestine, Texas, Vereinigte Staaten, 75801
- Rekrutierung
- Texas Oncology - Northeast Texas
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Paris, Texas, Vereinigte Staaten, 75460
- Rekrutierung
- Texas Oncology - Northeast Texas
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Pearland, Texas, Vereinigte Staaten, 77584
- Rekrutierung
- Texas Oncology - Gulf Coast
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Plano, Texas, Vereinigte Staaten, 75075
- Rekrutierung
- Texas Oncology - DFW
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Plano, Texas, Vereinigte Staaten, 75093
- Rekrutierung
- Texas Oncology - DFW
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San Antonio, Texas, Vereinigte Staaten, 78240
- Rekrutierung
- Texas Oncology - San Antonio
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San Antonio, Texas, Vereinigte Staaten, 78217
- Rekrutierung
- Texas Oncology - San Antonio
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San Antonio, Texas, Vereinigte Staaten, 78258
- Rekrutierung
- Texas Oncology - San Antonio
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Sugar Land, Texas, Vereinigte Staaten, 77479
- Rekrutierung
- Texas Oncology - Gulf Coast
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The Woodlands, Texas, Vereinigte Staaten, 77380
- Rekrutierung
- Texas Oncology - Gulf Coast
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Tyler, Texas, Vereinigte Staaten, 75702
- Rekrutierung
- Texas Oncology - Northeast Texas
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Webster, Texas, Vereinigte Staaten, 77598
- Rekrutierung
- Texas Oncology - Gulf Coast
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Virginia
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Blacksburg, Virginia, Vereinigte Staaten, 24060
- Rekrutierung
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Chesapeake, Virginia, Vereinigte Staaten, 23320
- Rekrutierung
- Virginia Oncology Associates
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Hampton, Virginia, Vereinigte Staaten, 23666
- Rekrutierung
- Virginia Oncology Associates
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Low Moor, Virginia, Vereinigte Staaten, 24457
- Rekrutierung
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Newport News, Virginia, Vereinigte Staaten, 23606
- Rekrutierung
- Virginia Oncology Associates
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Norfolk, Virginia, Vereinigte Staaten, 23502
- Rekrutierung
- Virginia Oncology Associates
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Roanoke, Virginia, Vereinigte Staaten, 24014
- Rekrutierung
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Salem, Virginia, Vereinigte Staaten, 24153
- Rekrutierung
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Virginia Beach, Virginia, Vereinigte Staaten, 23456
- Rekrutierung
- Virginia Oncology Associates
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Williamsburg, Virginia, Vereinigte Staaten, 23188
- Rekrutierung
- Virginia Oncology Associates
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Wytheville, Virginia, Vereinigte Staaten, 24382
- Rekrutierung
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Phase 2 Single arm
Participants will receive PF-08634404 in combination with chemotherapy |
Injection for intravenous use Concentrate for solution for infusion |
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Experimental: Phase 3 Experimental Arm
Participants will receive PF-08634404 in combination with chemotherapy |
Injection for intravenous use Concentrate for solution for infusion |
|
Aktiver Komparator: Phase3 Control Arm
Participants will receive atezolizumab in combination with chemotherapy |
Injection for intravenous use Injection for intravenous use |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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
|
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Phase 2: Number of participants with treatment-emergent adverse events
Zeitfenster: Up to 90 days after the last dose of treatment
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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
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Phase 3: Overall Survival (OS)
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pharmakokinetik: Serumkonzentrationen von PF-08634404
Zeitfenster: Bis zu 37 Tage nach der letzten Dosis der Behandlung
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Bis zu 37 Tage nach der letzten Dosis der Behandlung
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Inzidenz von Antidrogen-Antikörpern gegen PF-08634404
Zeitfenster: Bis zu 37 Tage nach der letzten Dosis der Behandlung
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Bis zu 37 Tage nach der letzten Dosis der Behandlung
|
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Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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
|
|
Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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
Zeitfenster: Up to 90 days after the last dose of treatment
|
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)
Zeitfenster: Up to 90 days after the last dose of treatment
|
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
|
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Phase 2: Overall Survival
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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)
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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)
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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)
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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
Zeitfenster: Up to approximately 2 years after completion of study treatment of last study participant
|
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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Pfizer CT.gov Call Center, Pfizer
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- C6461004
- 2025-523522-41-00 (Ctis)
- Symbiotic-Lung-04 (Andere Kennung: Pfizer)
- 2025 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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