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

수술 가능한 비소세포폐암(NSCLC) 성인 환자를 위한 Cemiplimab + 화학요법과 Cemiplimab + 화학요법 + 기타 암 치료에 대한 연구

2026년 10월 30일 업데이트: Regeneron Pharmaceuticals

절제 가능한 비소세포폐암 환자의 수술 전후 치료를 위한 세미플리맙+화학요법과 세미플리맙+화학요법+기타 암 치료법을 평가하기 위한 무작위 제2상 플랫폼 연구

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer (NSCLC) for whom surgery is planned, in the resectable NSCLC portion.

The aim of the resectable NSCLC portion is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.

For each investigational arm, the available data will be reviewed to decide whether safety testing with chemotherapy is needed before moving the treatment combination to the main resectable NSCLC portion of the study. If safety testing with chemotherapy is required, adult participants whose tumour has spread to other organs or cannot be removed by surgery, will be enrolled in the unresectable/metastatic NSCLC portion of the study called the "safety lead-in."

The aim of the unresectable/metastatic NSCLC safety lead-in portion is to evaluate the safety of the combination of Cemiplimab, chemotherapy, and an additional drug in participants with unresectable or metastatic NSCLC.

For the resectable NSCLC portion, the study is also looking at several other research questions, including:

  • What are the side effects associated with the investigational treatments in comparison to the control treatment
  • Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed
  • How much of the study drug(s) are in the blood at a given time
  • Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)

For the unresectable/metastatic NSCLC portion, the study is also looking at several other research questions, including:

  • What are the side effects associated with the additional drug in combination with cemiplimab and chemotherapy
  • How does the additional drug work in combination with cemiplimab and chemotherapy

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

184

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 독일
      • Aachen, 독일, 52074
        • University Hospital RWTH Aachen
    • Hesse
      • Kassel, Hesse, 독일, 34125
        • Klinikum Kassel GmbH, Hauttumorzentrum
    • Lower Saxony
      • Göttingen, Lower Saxony, 독일, 37083
        • University Medicine Gottingen
    • Saxony
      • Leipzig, Saxony, 독일, 04103
        • University of Leipzig
  • 미국
    • California
      • Orange, California, 미국, 92868
        • University of California Irvine
    • Illinois
      • Skokie, Illinois, 미국, 60077
        • Orchard Healthcare Research Inc.
    • Michigan
      • Detroit, Michigan, 미국, 48201
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, 미국, 48334
        • Detroit Clinical Research Center
    • Ohio
      • Cincinnati, Ohio, 미국, 45245
        • Oncology Hematology Care Clinical Trials LLC
    • Oregon
      • Portland, Oregon, 미국, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, 미국, 97213
        • University Of Nebraska Medical Center
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903
        • Lifespan Cancer Institute
    • South Dakota
      • Watertown, South Dakota, 미국, 57201
        • Prairie Lakes Healthcare System
    • Tennessee
      • Knoxville, Tennessee, 미국, 37920
        • University of Tennessee Medical Center
      • Nashville, Tennessee, 미국, 37203
        • Sarah Cannon Research Institute (SCRI) Oncology Partners
    • Virginia
      • Blacksburg, Virginia, 미국, 24060
        • BRCC/Oncology & Hematology Associates of SW Virginia
  • 브라질
      • São Paulo, 브라질, 01323-903
        • Hospital Alemao Oswaldo Cruz
    • Espírito Santo
      • Cachoeiro de Itapemirim, Espírito Santo, 브라질, 29306014
        • Oncology Clinical Research Center
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, 브라질, 30380-472
        • Instituto Mario Penna
      • Pouso Alegre, Minas Gerais, 브라질, 37554-238
        • Instituto Sul Mineiro De Oncologia LTDA
    • Pernambuco
      • Recife, Pernambuco, 브라질, 50070-902
        • Instituto de Medicina Integral Professor Fernando Figueira
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, 브라질, 59060-195
        • Liga Norte Riograndense Contra o Cancer
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, 브라질, 90610-000
        • Hospital Sao Lucas da PUCRS
      • Porto Alegre, Rio Grande do Sul, 브라질, 90110-270
        • Hospital Mae de Deus Integrated Oncology Center
    • Santa Catarina
      • Florianópolis, Santa Catarina, 브라질, 88020-210
        • Ynova Pesquisa Clinica
    • São Paulo
      • Sorocaba, São Paulo, 브라질, 18065-100
        • Unimed Sorocaba
      • São José do Rio Preto, São Paulo, 브라질, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • 스페인
      • Madrid, 스페인, 28046
        • Hospital Universitario La Paz
      • Madrid, 스페인, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, 스페인, 28033
        • MD Anderson Cancer Center
      • Madrid, 스페인, 28050
        • Hospital Universitario HM Sanchinarro
      • Seville, 스페인, 41013
        • Hospital Virgen del Rocio
      • Valencia, 스페인, 46014
        • Consorci Hospital General Universitario de Valencia
      • Valencia, 스페인, 46010
        • Hospital Clinico Universitario Valencia
      • Zaragoza, 스페인, 50009
        • Hospital Clinico Lozano Blesa
    • Barcelona
      • Badalona, Barcelona, 스페인, 08916
        • Catalan Instituye of Oncology Badalona
    • Cantabria
      • Santander, Cantabria, 스페인, 39008
        • Hospital Valdecilla
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, 스페인, 35016
        • Hospital Universitario Insular de Gran Canaria
    • Navarre
      • Pamplona, Navarre, 스페인, 31008
        • Clinica Universidad de Navarra
  • 터키 (Türkiye)
      • Istanbul, 터키 (Türkiye), 34295
        • Florya Medical Park Hospital
  • 프랑스
      • Bayonne, 프랑스, 64100
        • Clinique Belharra
      • Bayonne, 프랑스, 64100
        • Centre Hospitalier de la Cote Basque
      • Grenoble, 프랑스, 38330
        • CHU Grenoble Alpes
      • Montpellier, 프랑스, 34295
        • Montpellier Academic Hospital
    • Brittany Region
      • Rennes, Brittany Region, 프랑스, 35033
        • CHU Rennes
    • Var
      • Toulon, Var, 프랑스, 83055
        • Centre Hospitalier Intercommunal Toulon - CHITS
    • Île-de-France Region
      • Paris, Île-de-France Region, 프랑스, 75005
        • Institut Curie

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

Neoadjuvant Resectable NSCLC General Key Inclusion Criteria:

  1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
  2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
  3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
  4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
  5. Adequate organ and bone marrow function, as described in the protocol

Arm Specific Inclusion Criteria:

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:

  1. Non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC
  2. Availability of an archival or on-trial FFPE tumor tissue sample
  3. ECOG performance status of 0 or 1
  4. Per investigator judgment, life expectancy of at least 3 months

Neoadjuvant Resectable NSCLC General Key Exclusion Criteria:

  1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
  2. Presence of actionable oncogenic alterations in the tumor for which an approved targeted therapy is available or for which perioperative chemoimmunotherapy is not considered an appropriate standard of care treatment, as described in the protocol
  3. Presence of grade≥ 2 peripheral neuropathy
  4. Another malignancy that is progressing or requires active treatment, as described in the protocol

Arm Specific Exclusion Criteria:

Neoadjuvant Resectable NSCLC - Arm 1:

  1. Grade ≥3 hypercalcemia, as defined in the protocol
  2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
  3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2:

  1. Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
  2. Presence of actionable oncogenic alterations in the tumor for which a chemotherapy plus programmed cell death protein 1 (PD1) inhibitor backbone is not the appropriate initial therapy as standard of care
  3. Known allergy or hypersensitivity to any components of trial interventions
  4. Any condition requiring ongoing/continuous corticosteroid therapy, as described in the protocol

Neoadjuvant Resectable NSCLC - Arm 2:

1. History of encephalitis, meningitis, organic brain disease, or uncontrolled seizures within 1 year prior to the first dose of trial interventions.

Note: Other protocol-defined Inclusion/Exclusion criteria apply.

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Neoadjuvant Resectable NSCLC - Control Arm
의약품: Cemiplimab

Administered per the protocol

다른 이름들:
  • REGN2810
  • 립타요
의약품: Platinum-based chemotherapy

Administered per the protocol
실험적: Neoadjuvant Resectable NSCLC - Arm 1
의약품: Marlotamig

Administered per the protocol

다른 이름들:
  • REGN7075
의약품: Cemiplimab

Administered per the protocol

다른 이름들:
  • REGN2810
  • 립타요
의약품: Platinum-based chemotherapy

Administered per the protocol
실험적: Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
의약품: Cemiplimab

Administered per the protocol

다른 이름들:
  • REGN2810
  • 립타요
의약품: Platinum-based chemotherapy

Administered per the protocol

의약품: REGN10597

Administered per the protocol

다른 이름들:
  • PD-1-IL2Ra-IL2 immunotherapy
실험적: Neoadjuvant Resectable NSCLC - Arm 2
의약품: Cemiplimab

Administered per the protocol

다른 이름들:
  • REGN2810
  • 립타요
의약품: Platinum-based chemotherapy

Administered per the protocol

의약품: REGN10597

Administered per the protocol

다른 이름들:
  • PD-1-IL2Ra-IL2 immunotherapy

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Major Pathologic Response (MPR) rate as determined by central Blinded Independent Pathology Review (BIPR)
기간: Up to 12 weeks
Up to 12 weeks
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
기간: Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks
Occurrence of TEAEs leading to death
기간: Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks
Occurrence of TEAEs leading to treatment discontinuation
기간: Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks
Occurrence of Serious Adverse Events (SAEs)
기간: Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks
Occurrence of grade ≥3 laboratory abnormalities
기간: Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2

As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)
Up to 9 weeks
Number of participants unable to receive cemiplimab and chemotherapy for 2 consecutive cycles due to REGN10597-related toxicities during the first 3 cycles
기간: Up to 9 weeks

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 9 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
전체 생존(OS)
기간: 최대 5년
최대 5년
TEAE의 심각도
기간: 최대 76주
최대 76주
TEAE로 인해 수술이 지연된 비율
기간: 최대 76주
최대 76주
TEAE로 인해 취소된 수술 비율
기간: 최대 76주
최대 76주
Pathologic Complete Response (pCR) rate as determined by central BIPR
기간: Up to 12 weeks
Up to 12 weeks
Residual Viable Tumor (RVT) as determined by central BIPR
기간: Up to 12 weeks
Up to 12 weeks
Event-Free Survival (EFS)
기간: Up to 5 years
Up to 5 years
Objective Response by investigator assessment
기간: Up to 9 weeks
Up to 9 weeks
Duration of Response (DoR) by investigator assessment
기간: Up to 2 years

Unresectable/Metastatic NSCLC Safety Lead-in - Arm 2
Up to 2 years
Occurrence of TEAEs
기간: Up to 76 weeks
Up to 76 weeks
Occurrence of TEAEs leading to death
기간: Up to 76 weeks
Up to 76 weeks
Occurrence of TEAEs leading to treatment discontinuation
기간: Up to 76 weeks
Up to 76 weeks
Occurrence of SAEs
기간: Up to 76 weeks
Up to 76 weeks
Severity of SAEs
기간: Up to 76 weeks
Up to 76 weeks
Occurrence of Adverse Events of Special Interest (AESIs)
기간: Up to 76 weeks
Up to 76 weeks
Severity of AESIs
기간: Up to 76 weeks
Up to 76 weeks
Occurrence of immune-mediated Adverse Events (imAEs)
기간: Up to 76 weeks
Up to 76 weeks
Severity of imAEs
기간: Up to 76 weeks
Up to 76 weeks
Occurrence of Infusion-Related Reactions (IRRs)
기간: Up to 76 weeks
Up to 76 weeks
Severity of IRRs
기간: Up to 76 weeks
Up to 76 weeks
Occurrence of grade ≥3 laboratory abnormalities
기간: Up to 76 weeks

As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)
Up to 76 weeks
Occurrence of Anti-Drug Antibodies (ADAs) to cemiplimab
기간: Up to 67 weeks
Up to 67 weeks
Magnitude of ADAs to cemiplimab
기간: Up to 67 weeks
Up to 67 weeks
Occurrence of ADAs to marlotamig
기간: Up to 67 weeks
Up to 67 weeks
Magnitude of ADAs to marlotamig
기간: Up to 67 weeks
Up to 67 weeks
Occurrence of ADAs to REGN10597
기간: Up to 67 weeks
Up to 67 weeks
Magnitude of ADAs to REGN10597
기간: Up to 67 weeks
Up to 67 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Regeneron Pharmaceuticals

수사관

  • 연구 책임자: Clinical Trial Management, Regeneron Pharmaceuticals

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)

2024년 11월 18일

기본 완료 (추정된)

2029년 12월 4일

연구 완료 (추정된)

2034년 12월 27일

연구 등록 날짜

최초 제출

2024년 6월 13일

QC 기준을 충족하는 최초 제출

2024년 6월 13일

처음 게시됨 (실제)

2024년 6월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 30일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • R2810-ONC-2268
  • 2023 (미국 NIH 보조금/계약)
  • 2023-509806-31-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD 공유 기간

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD 공유 액세스 기준

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

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. .

구독하다