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광범위 병기 소세폐암 성인 환자에서 화학요법과 함께 PF-08634404 연구 의약품에 대해 알아보는 연구

2026년 10월 6일 업데이트: Pfizer

광범위 병기 소세폐암 환자를 대상으로 화학요법과 병용 투여되는 PF-08634404의 글로벌 2상/3상 중재적 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

550

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대만
      • Tainan, 대만, 704302
        • 모병
        • National Cheng Kung University Hospital
      • Taipei, 대만, 10002
        • 모병
        • National Taiwan University Hospital
      • Taipei, 대만, 110
        • 모병
        • Taipei Medical University Hospital
  • 독일
      • Düsseldorf, 독일, 40479
        • 모병
        • Marien Hospital Düsseldorf
      • Frankfurt am Main, 독일, 60488
        • 모병
        • Krankenhaus Nordwest GmbH
  • 미국
    • Arkansas
      • Fayetteville, Arkansas, 미국, 72703
        • 모병
        • Highlands Oncology Group
      • Rogers, Arkansas, 미국, 72758
        • 모병
        • Highlands Oncology Group
      • Springdale, Arkansas, 미국, 72762
        • 모병
        • Highlands Oncology Group
    • Florida
      • Coral Springs, Florida, 미국, 33065
        • 모병
        • BRCR Coral Springs
      • Orange City, Florida, 미국, 32763
        • 모병
        • Mid Florida Hematology and Oncology Center
      • Tamarac, Florida, 미국, 33321
        • 모병
        • BRCR Global - Tamarac
    • Ohio
      • Cleveland, Ohio, 미국, 44106
        • 모병
        • University Hospitals Cleveland Medical Center
    • Texas
      • Allen, Texas, 미국, 75013
        • 모병
        • Texas Oncology - Northeast Texas
      • Arlington, Texas, 미국, 76012
        • 모병
        • Texas Oncology - DFW
      • Arlington, Texas, 미국, 76014
        • 모병
        • Texas Oncology - DFW
      • Beaumont, Texas, 미국, 77702
        • 모병
        • Texas Oncology - Gulf Coast
      • Bedford, Texas, 미국, 76022
        • 모병
        • Texas Oncology - DFW
      • Dallas, Texas, 미국, 75246
        • 모병
        • Texas Oncology - DFW
      • Dallas, Texas, 미국, 75203
        • 모병
        • Texas Oncology - DFW
      • Dallas, Texas, 미국, 75230
        • 모병
        • Texas Oncology - DFW
      • Dallas, Texas, 미국, 75231
        • 모병
        • Texas Oncology - DFW
      • Dallas, Texas, 미국, 75237
        • 모병
        • Texas Oncology - DFW
      • Denison, Texas, 미국, 75020
        • 모병
        • Texas Oncology - Northeast Texas
      • Denton, Texas, 미국, 76201
        • 모병
        • Texas Oncology - Northeast Texas
      • Flower Mound, Texas, 미국, 75028
        • 모병
        • Texas Oncology - Northeast Texas
      • Fort Worth, Texas, 미국, 76104
        • 모병
        • Texas Oncology - DFW
      • Fredericksburg, Texas, 미국, 78624
        • 모병
        • Texas Oncology - San Antonio
      • Grapevine, Texas, 미국, 76051
        • 모병
        • Texas Oncology - DFW
      • Houston, Texas, 미국, 77024
        • 모병
        • Texas Oncology - Gulf Coast
      • Houston, Texas, 미국, 77054
        • 모병
        • Texas Oncology - Gulf Coast
      • Irving, Texas, 미국, 75063
        • 모병
        • US Oncology Investigational Products Center (IPC)
      • Irving, Texas, 미국, 75063
        • 모병
        • US Oncology Investigational Product Center (IPC)
      • Lewisville, Texas, 미국, 75056
        • 모병
        • Texas Oncology - Northeast Texas
      • Longview, Texas, 미국, 75601
        • 모병
        • Texas Oncology - Northeast Texas
      • McKinney, Texas, 미국, 75071
        • 모병
        • Texas Oncology - Northeast Texas
      • New Braunfels, Texas, 미국, 78130
        • 모병
        • Texas Oncology - San Antonio
      • Palestine, Texas, 미국, 75801
        • 모병
        • Texas Oncology - Northeast Texas
      • Paris, Texas, 미국, 75460
        • 모병
        • Texas Oncology - Northeast Texas
      • Pearland, Texas, 미국, 77584
        • 모병
        • Texas Oncology - Gulf Coast
      • Plano, Texas, 미국, 75075
        • 모병
        • Texas Oncology - DFW
      • Plano, Texas, 미국, 75093
        • 모병
        • Texas Oncology - DFW
      • San Antonio, Texas, 미국, 78240
        • 모병
        • Texas Oncology - San Antonio
      • San Antonio, Texas, 미국, 78217
        • 모병
        • Texas Oncology - San Antonio
      • San Antonio, Texas, 미국, 78258
        • 모병
        • Texas Oncology - San Antonio
      • Sugar Land, Texas, 미국, 77479
        • 모병
        • Texas Oncology - Gulf Coast
      • The Woodlands, Texas, 미국, 77380
        • 모병
        • Texas Oncology - Gulf Coast
      • Tyler, Texas, 미국, 75702
        • 모병
        • Texas Oncology - Northeast Texas
      • Webster, Texas, 미국, 77598
        • 모병
        • Texas Oncology - Gulf Coast
    • Virginia
      • Blacksburg, Virginia, 미국, 24060
        • 모병
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Chesapeake, Virginia, 미국, 23320
        • 모병
        • Virginia Oncology Associates
      • Hampton, Virginia, 미국, 23666
        • 모병
        • Virginia Oncology Associates
      • Low Moor, Virginia, 미국, 24457
        • 모병
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Newport News, Virginia, 미국, 23606
        • 모병
        • Virginia Oncology Associates
      • Norfolk, Virginia, 미국, 23502
        • 모병
        • Virginia Oncology Associates
      • Roanoke, Virginia, 미국, 24014
        • 모병
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Salem, Virginia, 미국, 24153
        • 모병
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Virginia Beach, Virginia, 미국, 23456
        • 모병
        • Virginia Oncology Associates
      • Williamsburg, Virginia, 미국, 23188
        • 모병
        • Virginia Oncology Associates
      • Wytheville, Virginia, 미국, 24382
        • 모병
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • 스페인
      • Barcelona, 스페인, 08035
        • 모병
        • Hospital Universitari Vall d'Hebron
      • Barcelona, 스페인, 08003
        • 모병
        • Parc de Salut Mar - Hospital del Mar
      • Barcelona, 스페인, 08029
        • 모병
        • CETIR
      • Jaén, 스페인, 23007
        • 모병
        • Hospital Universitario de Jaen
    • Andalusia
      • Jaén, Andalusia, 스페인, 23007
        • 모병
        • HT Médica Jaen LAs Nieves
    • Cádiz
      • Jerez de la Frontera, Cádiz, 스페인, 11407
        • 모병
        • Hospital Jerez de la Frontera
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, 스페인, 28041
        • 모병
        • Hospital Universitario 12 de Octubre
  • 이탈리아
    • Pordenone
      • Aviano, Pordenone, 이탈리아, 33081
        • 모병
        • Centro di Riferimento Oncologico (CRO) IRCCS
    • ROME
      • Roma, ROME, 이탈리아, 00144
        • 모병
        • IRCCS Istituto Nazionale dei Tumori Regina Elena
    • Turin
      • Orbassano, Turin, 이탈리아, 10043
        • 모병
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
  • 일본
    • Osaka
      • Hirakata, Osaka, 일본, 573-1191
        • 모병
        • Kansai Medical University Hospital
    • Shizuoka
      • Nagaizumi-cho, Shizuoka, 일본, 411-8777
        • 모병
        • Shizuoka Cancer Center
    • Tokyo
      • Kotoku, Tokyo, 일본, 135-8550
        • 모병
        • Japanese Foundation for Cancer Research
  • 중국
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510180
        • 모병
        • Guangdong Provincial People's Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200032
        • 모병
        • Fudan University Shanghai Cancer Center
  • 푸에르토 리코
      • Manati, 푸에르토 리코, 00674
        • 모병
        • Doctor's Center Hematology & Oncology Group
      • Mayagüez, 푸에르토 리코, 00680
        • 모병
        • Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center
      • San Juan, 푸에르토 리코, 00935
        • 모병
        • Hospital Oncologico Dr. Isaac Gonzalez-Martinez
      • San Juan, 푸에르토 리코, 00909
        • 모병
        • Pan American Center for Oncology Trials LLC
  • 프랑스
      • Villejuif, 프랑스, 94805
        • 모병
        • Gustave Roussy
    • Île-de-France Region
      • Boulogne-Billancourt, Île-de-France Region, 프랑스, 92100
        • 모병
        • Hôpital Ambroise Paré
  • 호주
    • New South Wales
      • Westmead, New South Wales, 호주, 2145
        • 모병
        • Westmead Hospital
    • Queensland
      • Birtinya, Queensland, 호주, 4575
        • 모병
        • Sunshine Coast University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Phase 2 Single arm

Participants will receive PF-08634404 in combination with chemotherapy
의약품: Chemotherapy

Injection for intravenous use

의약품: PF-08634404

Concentrate for solution for infusion
실험적: Phase 3 Experimental Arm

Participants will receive PF-08634404 in combination with chemotherapy
의약품: Chemotherapy

Injection for intravenous use

의약품: PF-08634404

Concentrate for solution for infusion
활성 비교기: Phase3 Control Arm

Participants will receive atezolizumab in combination with chemotherapy
의약품: Chemotherapy

Injection for intravenous use

생물학적: Atezolizumab

Injection for intravenous use

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
약동학: PF-08634404의 혈청 농도
기간: 치료 마지막 투여 후 최대 37일
치료 마지막 투여 후 최대 37일
PF-08634404에 대한 항약물 항체 발생률
기간: 치료의 마지막 투여 후 최대 37일
치료의 마지막 투여 후 최대 37일
Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

수사관

  • 연구 책임자: Pfizer CT.gov Call Center, Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 12월 9일

기본 완료 (추정된)

2030년 6월 14일

연구 완료 (추정된)

2034년 3월 11일

연구 등록 날짜

최초 제출

2025년 11월 7일

QC 기준을 충족하는 최초 제출

2025년 11월 7일

처음 게시됨 (실제)

2025년 11월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 6일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • C6461004
  • 2025-523522-41-00 (씨티스)
  • Symbiotic-Lung-04 (기타 식별자: Pfizer)
  • 2025 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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