이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Symbiotic-Lung-10: 조기 또는 국소 진행성 NSCLC에서 PF-08634404 단독 또는 병용 요법에 대한 연구

2026년 10월 6일 업데이트: Pfizer

조기 단계 절제 가능 또는 국소 진행성 절제 불가능 비소세포폐암 성인 참가자를 대상으로 PF-08634404 단독 요법 또는 병용 요법의 안전성과 유효성을 조사하는 개방형, 중재적, 2상 연구

This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.

The study is seeking participants who:

  • Are aged 18 years or older

  • Have either:

    • Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.
    • Early-stage or locally advanced (Stage II or IIIA/B) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.
    • Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.

  • Be in good physical condition and have healthy organs based on medical tests.

  • Do not have known actionable changes in DNA

The study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:

  • Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.
  • Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.
  • Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.

All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

120

단계

  • 2 단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 대만
      • Taichung, 대만, 40201
        • 모병
        • Chung Shan Medical University Hospital
      • Tainan, 대만, 704
        • 모병
        • National Cheng Kung University Hospital
      • Taipei, 대만, 100
        • 아직 모집하지 않음
        • National Taiwan University Hospital
      • Taipei, 대만, 11217
        • 모병
        • Taipei Veterans General Hospital
      • Taipei, 대만, 110
        • 모병
        • Taipei Medical University Hospital
  • 독일
      • Großhansdorf, 독일, 22927
        • 아직 모집하지 않음
        • LungenClinic Grosshansdorf
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, 독일, 40479
        • 아직 모집하지 않음
        • Marien Hospital Düsseldorf
  • 미국
    • Alabama
      • Huntsville, Alabama, 미국, 35805
        • 모병
        • Clearview Cancer Institute
      • Huntsville, Alabama, 미국, 35801
        • 모병
        • Clearview Cancer Institute (Crestwood)
    • California
      • Stanford, California, 미국, 94305
        • 모병
        • Stanford Hospital and Clinics
      • Stanford, California, 미국, 94305
        • 모병
        • Stanford Cancer Institute
      • Stanford, California, 미국, 94305
        • 모병
        • Stanford Hospital Investigational Drug Services
    • Georgia
      • Athens, Georgia, 미국, 30607
        • 모병
        • University Cancer & Blood Center, LLC
    • Illinois
      • Hinsdale, Illinois, 미국, 60521
        • 모병
        • Hope and Healing Clinical Research
      • New Lenox, Illinois, 미국, 60451
        • 모병
        • Hope and Healing Clinical Research
    • Nebraska
      • Bellevue, Nebraska, 미국, 68123
        • 아직 모집하지 않음
        • Nebraska Medicine- Bellevue Medical Center
      • Lincoln, Nebraska, 미국, 68516
        • 모병
        • Cancer Partners of Nebraska
      • Omaha, Nebraska, 미국, 68198
        • 아직 모집하지 않음
        • University of Nebraska Medical Center
      • Omaha, Nebraska, 미국, 68105
        • 아직 모집하지 않음
        • Nebraska Medicine
      • Omaha, Nebraska, 미국, 68118
        • 아직 모집하지 않음
        • Nebraska Medicine - Village Pointe
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87109
        • 모병
        • New Mexico Oncology Hematology Consultants, Ltd
    • Tennessee
      • Knoxville, Tennessee, 미국, 37920
        • 모병
        • University of Tennessee Medical Center
  • 스페인
      • Majadahonda, 스페인, 28222
        • 모병
        • Hospital Universitario Puerta de Hierro de Majadahonda
  • 이스라엘
    • TELL ABĪB
      • Tel Aviv, TELL ABĪB, 이스라엘, 6423906
        • 모병
        • Sourasky Medical Center
  • 이탈리아
    • Verona
      • Peschiera del Garda, Verona, 이탈리아, 37019
        • 아직 모집하지 않음
        • Casa di Cura Dott. Pederzoli
  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100142
        • 모병
        • Beijing Cancer hospital
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510180
        • 모병
        • Guangdong Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, 중국, 250117
        • 모병
        • The Affiliated Cancer Hospital of Shandong First Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200032
        • 모병
        • Fudan University Shanghai Cancer Center
  • 폴란드
      • Wroclaw, 폴란드, 53-439
        • 모병
        • Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
  • 푸에르토 리코
      • Bayamón, 푸에르토 리코, 00959
        • 모병
        • Pan American Center for Oncology Trials, LLC - Bayamón Office
      • Manati, 푸에르토 리코, 00674
        • 모병
        • Pan American Center for Oncology Trials, LLC - Manati Office
      • Ponce, 푸에르토 리코, 00730
        • 모병
        • Pan American Center for Oncology Trials, LLC - Ponce Office
      • Rio Piedras, 푸에르토 리코, 00935
        • 모병
        • Hospital Oncologico Dr. Isaac Gonzalez Martinez
      • San Juan, 푸에르토 리코, 00909
        • 모병
        • Pan American Center for Oncology Trials, LLC - Ciudadela Office
  • 호주
    • Victoria
      • St Albans, Victoria, 호주, 3021
        • 모병
        • Western Health-Sunshine & Footscray Hospitals
  • 홍콩
      • Hong Kong, 홍콩
        • 아직 모집하지 않음
        • Prince of Wales 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:

  • 18 years of age or older at screening.
  • Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
  • PD-L1 status available based on local testing results
  • Adequate organ function
  • Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
  • Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his/her practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.
  • Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.
  • Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.

Exclusion Criteria:

  • Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.

  • Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.

  • Participants with clinically significant risk of hemorrhage or fistula are excluded.

  • Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.

  • Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.

  • Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.

  • History of allogeneic organ / hematopoietic stem cell transplantation.

  • Participants with any of the following respiratory conditions:

    • Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
    • Grade ≥3 pulmonary disease unrelated to underlying malignancy

  • History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events.

  • Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention.

  • History of severe bleeding tendency or coagulation dysfunction

  • History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.

  • Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).

  • Participants with history of immunodeficiency

  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.

  • Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.

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: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Part A: Neoadjuvant PF-08634404 + Chemotherapy

Participants with treatment naïve early-stage or locally advanced, resectable NSCLC without Actionable Genomic Alterations (AGAs) who are candidates for neoadjuvant treatment will receive intravenous (IV) PF-08634404 in combination with chemotherapy.
생물학적: PF-08634404

Concentrate for solution for infusion

다른 이름들:
  • SSGJ-707
의약품: Chemotherapy Regimen 1

Injection for intravenous use

의약품: Chemotherapy Regimen 2

Injection for intravenous use
실험적: Part B: Adjuvant PF-08634404 Monotherapy

Participants with early-stage or locally advanced, resectable NSCLC without AGAs who did not achieve pCR after standard-of-care (SOC) neoadjuvant chemo-immunotherapy and are candidates for adjuvant treatment will receive PF-08634404 IV.
생물학적: PF-08634404

Concentrate for solution for infusion

다른 이름들:
  • SSGJ-707
실험적: Part C: PF-08634404 Monotherapy Consolidation after Definitive Chemoradiotherapy

Participants with locally advanced, unresectable NSCLC without AGAs who did not have progressive disease per RECIST 1.1 after definitive, platinum-based concurrent chemoradiotherapy (cCRT) and are candidates for consolidation treatment will receive PF-08634404 IV.
생물학적: PF-08634404

Concentrate for solution for infusion

다른 이름들:
  • SSGJ-707

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Adverse Events (AEs)
기간: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).
Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)
Part A: Surgical Feasibility Rate
기간: Up to approximately 6 months after first dose

Surgical Feasibility rate is defined by the proportion of participants undergoing surgery and the proportion of participants with wound complications after surgery.
Up to approximately 6 months after first dose
Part A: Pathological Complete Response (pCR) rate per International Association for the Study of Lung Cancer (IASLC) guidelines as assessed by central pathology review
기간: Up to approximately 6 months after first dose

pCR rate by central pathology review is defined as the proportion of participants having pCR as assessed by central pathologist. pCR is defined as the absence of residual tumor in surgical specimens
Up to approximately 6 months after first dose

2차 결과 측정

결과 측정
측정값 설명
기간
약물동태학: PF-086344의 혈청 농도
기간: 수술 전, 치료의 마지막 투여 후 최대 37일
수술 전, 치료의 마지막 투여 후 최대 37일
PF-08634404에 대한 항약물 항체 발생률
기간: 수술 전, 치료 마지막 투여 후 최대 37일
수술 전, 치료 마지막 투여 후 최대 37일
Part A: Major Pathological Response (MPR) rate per IASLC guidelines as assessed by central pathology review
기간: Up to approximately 6 months after first dose

MPR rate by central pathology review is defined as the proportion of participants having MPR as assessed by central pathologist or investigator respectively. MPR is defined as ≤10% residual tumor in surgical specimens.
Up to approximately 6 months after first dose
Part A: pCR rate per IASLC guidelines as assessed by investigator
기간: Up to approximately 6 months after first dose

pCR rate by investigator is defined as the proportion of participants having pCR as assessed by investigator. pCR is defined as the absence of residual tumor in surgical specimens.
Up to approximately 6 months after first dose
Part A: MPR rate per IASLC guidelines as assessed by investigator
기간: Up to approximately 6 months after first dose

MPR rate by investigator is defined as the proportion of participants having MPR as assessed by central pathologist or investigator respectively. MPR is defined as ≤10% residual tumor in surgical specimens.
Up to approximately 6 months after first dose
Part A: Event Free Survival (EFS) per RECIST v1.1 as assessed by investigator
기간: Up to approximately 5 years

EFS is defined as time from the date of first dose to the first occurrence of disease progression precluding surgery, inability to resect the tumor, disease progression or recurrence after surgery per RECIST v1.1 as assessed by investigator, or death due to any cause.
Up to approximately 5 years
Part A: Objective Response Rate (ORR) per RECIST v1.1 as assessed by investigator at the completion of neoadjuvant therapy, prior to surgery
기간: Up to approximately 5 years

ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) per RECIST v1.1.
Up to approximately 5 years
Part B: Disease Free Survival (DFS) per RECIST v1.1 as assessed by investigator
기간: Up to approximately 5 years

DFS is defined as time from the date of first dose to the date of first documented disease progression or recurrence per RECIST v1.1 as assessed by investigator or death due to any cause, whichever occurs first
Up to approximately 5 years
Part C: Confirmed ORR per RECIST v1.1 as assessed by investigator
기간: Up to approximately 5 years

Confirmed 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 investigator.
Up to approximately 5 years
Part C: Progression Free Survival (PFS) per RECIST v1.1 as assessed by investigator
기간: Up to approximately 5 years

PFS is defined as the time from the date of first dose to the date of the first documentation of objective Progression Disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first
Up to approximately 5 years
Overall Survival (OS)
기간: Up to approximately 5 years

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 5 years
Rate of circulating tumor DNA (ctDNA) reduction or clearance
기간: Part A: Up to 18 months, Part B and Part C: Up to 37 days after the last dose of treatment

Reduction in ctDNA is defined as a decrease in ctDNA burden from baseline to a specified on-treatment time point. ctDNA clearance is defined as a 100% reduction in ctDNA burden.
Part A: Up to 18 months, Part B and Part C: Up to 37 days after the last dose of treatment
Number of participants with Laboratory abnormalities
기간: Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0).
Through 90 days after the last dose of study intervention (Part A only: or 90 days after surgery, whichever is later)

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)

2026년 6월 30일

기본 완료 (추정된)

2028년 7월 29일

연구 완료 (추정된)

2031년 7월 30일

연구 등록 날짜

최초 제출

2026년 3월 17일

QC 기준을 충족하는 최초 제출

2026년 3월 17일

처음 게시됨 (실제)

2026년 3월 23일

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

  • C6461010
  • 2025-524825-42-00 (레지스트리 식별자: CTIS (EU))
  • Symbiotic-Lung-10 (기타 식별자: Alias Study Number)
  • 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

예

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. .

구독하다