Studie o studijním léčivu nazvaném PF-08634404 v kombinaci s chemoterapií u dospělých účastníků s rozsáhlým malobuněčným karcinomem plic
GLOBÁLNÍ FAZE 2/3 INTERVENČNÍ STUDIE PF-08634404 V KOMBINACI S CHEMOTERAPIÍ U ÚČASTNÍKŮ S EXTENZIVNÍM STADIEM MALOBUNĚČNÉHO KARCINOMU PLIC
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Pfizer CT.gov Call Center
- Telefonní číslo: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studijní místa
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New South Wales
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Westmead, New South Wales, Austrálie, 2145
- Nábor
- Westmead Hospital
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Queensland
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Birtinya, Queensland, Austrálie, 4575
- Nábor
- Sunshine Coast University Hospital
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Villejuif, Francie, 94805
- Nábor
- Gustave Roussy
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Île-de-France Region
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Boulogne-Billancourt, Île-de-France Region, Francie, 92100
- Nábor
- Hôpital Ambroise Paré
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Pordenone
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Aviano, Pordenone, Itálie, 33081
- Nábor
- Centro di Riferimento Oncologico (CRO) IRCCS
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ROME
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Roma, ROME, Itálie, 00144
- Nábor
- IRCCS Istituto Nazionale dei Tumori Regina Elena
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Turin
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Orbassano, Turin, Itálie, 10043
- Nábor
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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Osaka
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Hirakata, Osaka, Japonsko, 573-1191
- Nábor
- Kansai Medical University Hospital
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Shizuoka
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Nagaizumi-cho, Shizuoka, Japonsko, 411-8777
- Nábor
- Shizuoka Cancer Center
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Tokyo
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Kotoku, Tokyo, Japonsko, 135-8550
- Nábor
- Japanese Foundation for Cancer Research
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Düsseldorf, Německo, 40479
- Nábor
- Marien Hospital Düsseldorf
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Frankfurt am Main, Německo, 60488
- Nábor
- Krankenhaus Nordwest GmbH
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Manati, Portoriko, 00674
- Nábor
- Doctor's Center Hematology & Oncology Group
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Mayagüez, Portoriko, 00680
- Nábor
- Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center
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San Juan, Portoriko, 00935
- Nábor
- Hospital Oncologico Dr. Isaac Gonzalez-Martinez
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San Juan, Portoriko, 00909
- Nábor
- Pan American Center for Oncology Trials LLC
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Arkansas
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Fayetteville, Arkansas, Spojené státy, 72703
- Nábor
- Highlands Oncology Group
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Rogers, Arkansas, Spojené státy, 72758
- Nábor
- Highlands Oncology Group
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Springdale, Arkansas, Spojené státy, 72762
- Nábor
- Highlands Oncology Group
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Florida
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Coral Springs, Florida, Spojené státy, 33065
- Nábor
- BRCR Coral Springs
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Orange City, Florida, Spojené státy, 32763
- Nábor
- Mid Florida Hematology and Oncology Center
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Tamarac, Florida, Spojené státy, 33321
- Nábor
- BRCR Global - Tamarac
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Ohio
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Cleveland, Ohio, Spojené státy, 44106
- Nábor
- University Hospitals Cleveland Medical Center
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Texas
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Allen, Texas, Spojené státy, 75013
- Nábor
- Texas Oncology - Northeast Texas
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Arlington, Texas, Spojené státy, 76012
- Nábor
- Texas Oncology - DFW
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Arlington, Texas, Spojené státy, 76014
- Nábor
- Texas Oncology - DFW
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Beaumont, Texas, Spojené státy, 77702
- Nábor
- Texas Oncology - Gulf Coast
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Bedford, Texas, Spojené státy, 76022
- Nábor
- Texas Oncology - DFW
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Dallas, Texas, Spojené státy, 75246
- Nábor
- Texas Oncology - DFW
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Dallas, Texas, Spojené státy, 75203
- Nábor
- Texas Oncology - DFW
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Dallas, Texas, Spojené státy, 75230
- Nábor
- Texas Oncology - DFW
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Dallas, Texas, Spojené státy, 75231
- Nábor
- Texas Oncology - DFW
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Dallas, Texas, Spojené státy, 75237
- Nábor
- Texas Oncology - DFW
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Denison, Texas, Spojené státy, 75020
- Nábor
- Texas Oncology - Northeast Texas
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Denton, Texas, Spojené státy, 76201
- Nábor
- Texas Oncology - Northeast Texas
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Flower Mound, Texas, Spojené státy, 75028
- Nábor
- Texas Oncology - Northeast Texas
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Fort Worth, Texas, Spojené státy, 76104
- Nábor
- Texas Oncology - DFW
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Fredericksburg, Texas, Spojené státy, 78624
- Nábor
- Texas Oncology - San Antonio
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Grapevine, Texas, Spojené státy, 76051
- Nábor
- Texas Oncology - DFW
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Houston, Texas, Spojené státy, 77024
- Nábor
- Texas Oncology - Gulf Coast
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Houston, Texas, Spojené státy, 77054
- Nábor
- Texas Oncology - Gulf Coast
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Irving, Texas, Spojené státy, 75063
- Nábor
- US Oncology Investigational Products Center (IPC)
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Irving, Texas, Spojené státy, 75063
- Nábor
- US Oncology Investigational Product Center (IPC)
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Lewisville, Texas, Spojené státy, 75056
- Nábor
- Texas Oncology - Northeast Texas
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Longview, Texas, Spojené státy, 75601
- Nábor
- Texas Oncology - Northeast Texas
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McKinney, Texas, Spojené státy, 75071
- Nábor
- Texas Oncology - Northeast Texas
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New Braunfels, Texas, Spojené státy, 78130
- Nábor
- Texas Oncology - San Antonio
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Palestine, Texas, Spojené státy, 75801
- Nábor
- Texas Oncology - Northeast Texas
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Paris, Texas, Spojené státy, 75460
- Nábor
- Texas Oncology - Northeast Texas
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Pearland, Texas, Spojené státy, 77584
- Nábor
- Texas Oncology - Gulf Coast
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Plano, Texas, Spojené státy, 75075
- Nábor
- Texas Oncology - DFW
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Plano, Texas, Spojené státy, 75093
- Nábor
- Texas Oncology - DFW
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San Antonio, Texas, Spojené státy, 78240
- Nábor
- Texas Oncology - San Antonio
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San Antonio, Texas, Spojené státy, 78217
- Nábor
- Texas Oncology - San Antonio
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San Antonio, Texas, Spojené státy, 78258
- Nábor
- Texas Oncology - San Antonio
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Sugar Land, Texas, Spojené státy, 77479
- Nábor
- Texas Oncology - Gulf Coast
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The Woodlands, Texas, Spojené státy, 77380
- Nábor
- Texas Oncology - Gulf Coast
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Tyler, Texas, Spojené státy, 75702
- Nábor
- Texas Oncology - Northeast Texas
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Webster, Texas, Spojené státy, 77598
- Nábor
- Texas Oncology - Gulf Coast
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Virginia
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Blacksburg, Virginia, Spojené státy, 24060
- Nábor
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Chesapeake, Virginia, Spojené státy, 23320
- Nábor
- Virginia Oncology Associates
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Hampton, Virginia, Spojené státy, 23666
- Nábor
- Virginia Oncology Associates
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Low Moor, Virginia, Spojené státy, 24457
- Nábor
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Newport News, Virginia, Spojené státy, 23606
- Nábor
- Virginia Oncology Associates
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Norfolk, Virginia, Spojené státy, 23502
- Nábor
- Virginia Oncology Associates
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Roanoke, Virginia, Spojené státy, 24014
- Nábor
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Salem, Virginia, Spojené státy, 24153
- Nábor
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Virginia Beach, Virginia, Spojené státy, 23456
- Nábor
- Virginia Oncology Associates
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Williamsburg, Virginia, Spojené státy, 23188
- Nábor
- Virginia Oncology Associates
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Wytheville, Virginia, Spojené státy, 24382
- Nábor
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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Tainan, Tchaj-wan, 704302
- Nábor
- National Cheng Kung University Hospital
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Taipei, Tchaj-wan, 10002
- Nábor
- National Taiwan University Hospital
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Taipei, Tchaj-wan, 110
- Nábor
- Taipei Medical University Hospital
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Guangdong
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Guangzhou, Guangdong, Čína, 510180
- Nábor
- Guangdong Provincial People's Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200032
- Nábor
- Fudan University Shanghai Cancer Center
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Barcelona, Španělsko, 08035
- Nábor
- Hospital Universitari Vall d'Hebron
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Barcelona, Španělsko, 08003
- Nábor
- Parc de Salut Mar - Hospital del Mar
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Barcelona, Španělsko, 08029
- Nábor
- CETIR
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Jaén, Španělsko, 23007
- Nábor
- Hospital Universitario de Jaen
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Andalusia
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Jaén, Andalusia, Španělsko, 23007
- Nábor
- HT Médica Jaen LAs Nieves
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Cádiz
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Jerez de la Frontera, Cádiz, Španělsko, 11407
- Nábor
- Hospital Jerez de la Frontera
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Španělsko, 28041
- Nábor
- Hospital Universitario 12 de Octubre
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Phase 2 Single arm
Participants will receive PF-08634404 in combination with chemotherapy |
Injection for intravenous use Concentrate for solution for infusion |
|
Experimentální: Phase 3 Experimental Arm
Participants will receive PF-08634404 in combination with chemotherapy |
Injection for intravenous use Concentrate for solution for infusion |
|
Aktivní komparátor: Phase3 Control Arm
Participants will receive atezolizumab in combination with chemotherapy |
Injection for intravenous use Injection for intravenous use |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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
|
|
Phase 2: Number of participants with treatment-emergent adverse events
Časové okno: Up to 90 days after the last dose of treatment
|
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)
Časové okno: Up to approximately 2 years after completion of study treatment of last study participant
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Farmakokinetika: Sérové koncentrace přípravku PF-08634404
Časové okno: Až 37 dní po poslední dávce léčby
|
Až 37 dní po poslední dávce léčby
|
|
|
Výskyt protilátky proti léku PF-08634404
Časové okno: Až 37 dní po poslední dávce léčby
|
Až 37 dní po poslední dávce léčby
|
|
|
Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
|
|
Phase 2: Overall Survival
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C6461004
- 2025-523522-41-00 (Ctis)
- Symbiotic-Lung-04 (Jiný identifikátor: Pfizer)
- 2025 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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