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

사전 화학 요법을받지 못한 외과 적으로 제거 된 비소 세포 폐암 환자에서 Cemiplimab과 보조제 면역 요법의 효능을 평가하기위한 임상 연구. (ARCH)

2026년 10월 26일 업데이트: ETOP IBCSG Partners Foundation

사전 보조 화학 요법을받지 않은 절제된 단계 II-IIIA NSCLC 환자에서 보조제 삭제 클리 맙의 무작위 III 단계 시험.

ARCH is a randomised, stratified, multicentre, phase III trial. Protocol treatment consists of cemiplimab, 350 mg i.v., every 3 weeks, for 4 cycles, followed by 700 mg i.v., every 6 weeks for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first. The primary objective of the study is to determine the efficacy of adjuvant cemiplimab, as measured by disease-free survival, in patients without prior adjuvant platinum-based chemotherapy, compared to observation without adjuvant treatment. The primary objective will be assessed in patients with tumours with centrally confirmed PD-L1 expression of ≥1%.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

390

단계

  • 3단계

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

  • 독일
  • 스위스
      • Basel, 스위스
      • Winterthur, 스위스
  • 스페인
      • A Coruña, 스페인
      • Alicante, 스페인
        • 모병
        • Hospital General Universitario Dr. Balmis de Alicante
        • 연락하다:
      • Barakaldo, 스페인
      • Barcelona, 스페인
        • 모병
        • Hospital de La Santa Creu I Sant Pau
        • 연락하다:
      • Barcelona, 스페인
      • Granada, 스페인
        • 모병
        • Hospital Clínico San Cecilio de Granada
        • 연락하다:
      • Jerez de la Frontera, 스페인
      • Madrid, 스페인
      • Santa Cruz de Tenerife, 스페인
        • 모병
        • Hospital Universitario Nuestra Señora de Candelaria
        • 연락하다:
      • Valencia, 스페인
  • 싱가포르
      • Singapore, 싱가포르
  • 아일랜드
      • Cork, 아일랜드
        • 아직 모집하지 않음
        • Cork University Hospital
        • 연락하다:
          • Sinead Noonan
      • Dublin, 아일랜드
      • Dublin, 아일랜드
      • Dublin, 아일랜드
        • 아직 모집하지 않음
        • St. Vincent's University Hospital
        • 연락하다:
          • Sarah Lochrin
  • 에스토니아
  • 오스트리아
  • 이탈리아
      • Meldola, 이탈리아
        • 모병
        • IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
        • 연락하다:
      • Milan, 이탈리아
      • Milan, 이탈리아
      • Novara, 이탈리아
      • Pavia, 이탈리아
      • Perugia, 이탈리아
      • Prato, 이탈리아
        • 모병
        • Nuovo Ospedale di Prato Santo Stefano
        • 연락하다:
          • Daniele Pozzessere
      • Siena, 이탈리아
        • 아직 모집하지 않음
        • Azienda ospedaliero-universitaria Senese Siena
        • 연락하다:
      • Treviso, 이탈리아
      • Verona, 이탈리아
  • 프랑스

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:

  • Pathological stage II-IIIA (UICC/ AJCC staging 9th edition) NSCLC Brain imaging should have been performed to complete staging, either preoperatively or postoperatively. If brain imaging has not been performed, a contrast-enhanced CT or MRI of the brain must be performed at screening prior randomisation.

  • Complete resection with negative surgical margins (R0).

    • Acceptable types of surgical resection include any of the following:

  • Lobectomy, sleeve lobectomy, bilobectomy, or pneumectomy.

  • Segmentectomy for tumours ≤2 cm is permitted in patients with poor pulmonary reserve or another major comorbidity that contraindicates lobectomy.

    • Wedge resection is not allowed.
    • Lymph node dissection should be done according to applicable guidelines.
    • No disease recurrence following surgical resection.

  • Tumour PD-L1 expression of ≥1%, determined locally using a locally approved immuno-histochemistry test.

  • Availability of archival FFPE tumour tissue for central PD-L1 expression testing.

  • Patient is not considered for adjuvant platinum-based chemotherapy due to:

    • Documented patient refusal; or
    • Patient is unfit to receive adjuvant platinum-based chemotherapy (per investigator assessment) due to:

ECOG PS2, or ECOG PS 0/1 and aged ≥70 years with substantial comorbidities or other contraindication(s) to platinum-based doublet chemotherapy.

  • Estimated life expectancy of ≥3 months.
  • Age ≥18 years.
  • Patient has recovered from surgery-related complications.
  • Adequate haematological, renal and liver function.
  • Patient is able to comply with the trial protocol, in the investigator's judgment.
  • Negative pregnancy test Female participants of childbearing potential (including women who had their last menstruation in the last 2 years), must have a negative serum pregnancy test within 5 weeks before randomisation. Pregnancy test must be repeated within 3 days before the first dose of protocol treatment and at every treatment visit (urine beta HCG test is sufficient).
  • Use of highly effective contraceptive methods Female participants of childbearing potential (including women who had their last menstruation in the last 2 years) and male participants with a female partners of childbearing potential must agree to use a highly effective method of contraception for the duration of the protocol treatment and until 4 months after the last dose of cemiplimab.
  • Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention.

Exclusion Criteria:

  • EGFR-mutant or ALK-rearranged NSCLC.
  • Any small cell component
  • Prior neoadjuvant and/or adjuvant systemic treatment for NSCLC.

Note: Previous treatment for another malignancy not excluded as per next criterion (Participating in another interventional clinical trial for NSCLC) is allowed if the below conditions are fulfilled:

  • Treatment with an approved systemic therapy is completed >4 weeks before randomisation or

  • Treatment with systemic biologic therapy is completed >5 half-lives before randomisation and patient has recovered from any immune-mediated adverse events and endocrinopathies are adequately managed with hormone replacement.

    • Participating in another interventional clinical trial for NSCLC.
    • Diagnosis with another malignancy other than NSCLC that is progressing or requires active treatment.

Exceptions:

  • Non-melanoma skin cancer that has undergone potentially curative therapy

  • In situ cervical carcinoma

  • Any tumour that has been deemed to be definitively treated, such as definitively treated non-metastatic prostate cancer.

    • Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to randomisation. Physiologic replacement doses are allowed even if they are >10 mg of prednisone per day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.

Note: Patients who require a brief course of steroids (ex. 3 days in the week before randomisation) or physiologic replacement are allowed to be included in the study.

  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.

The following are not exclusions: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.

  • Encephalitis, meningitis, organic brain disease (e.g., Parkinson's disease) or uncontrolled seizures within 1 year prior to randomisation.

  • Myocardial infarction within 6 months prior to randomisation.

  • Known history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis within 5 years prior to randomisation.

  • Uncontrolled infection with HIV, hepatitis B, or hepatitis C infection; or the patient has a diagnosis of immunodeficiency.

    • Patients with known HIV infection who have controlled infection [undetectable viral load (HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen] are allowed to be included in the study. Patients with controlled HIV infection should be monitored according to local standards.
    • Patients with hepatitis B (HBsAg+) with controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection and receiving antiviral therapy for hepatitis B) may be included in the study. Patients with controlled infection must undergo regular monitoring of HBV DNA. Patients must remain on antiviral therapy for at least 6 months after the last dose of cemiplimab.
    • Patients who are hepatitis C virus antibody positive (HCV Ab+) with controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be included in the study.

  • Any infection requiring hospitalisation or treatment with intravenous anti-infectives within 2 weeks before randomisation.

  • Receipt of a live vaccine within 28 days before randomisation.

  • Receipt of a COVID-19 vaccination within 1 week before randomisation.

  • Prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation within 12 weeks before randomisation.

  • Known or suspected hypersensitivity to cemiplimab or its excipients.

  • Women who are pregnant, planning to become pregnant or are in the period of lactation.

  • Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.

  • Patients who are, or have an immediate family member who is, a member of the clinical study team, unless prior approval has been obtained from the sponsor (ETOP IBCSG Partners Foundation).

  • Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.

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
실험적: Experimental Arm: Cemiplimab

Cemiplimab, 350 mg i.v., every 3 weeks (±3 days), for 4 cycles, followed by 700 mg i.v., every 6 weeks (±1 week) for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first.
의약품: Cemiplimab

Cemiplimab, 350 mg i.v., every 3 weeks (±3 days), for 4 cycles, followed by 700 mg i.v., every 6 weeks (±1 week) for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first.
간섭 없음: Control Arm: Observation

Observation.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Disease-free survival (DFS)
기간: From the date of randomisation until disease recurrence (including loco-regional recurrence, a distant (metastatic) recurrence or a second primary) or death from any cause. Assessed for approximately up to 59 months.

Disease free survival (in patients with tumours with centrally confirmed PD-L1 expression of ≥1%).
From the date of randomisation until disease recurrence (including loco-regional recurrence, a distant (metastatic) recurrence or a second primary) or death from any cause. Assessed for approximately up to 59 months.

2차 결과 측정

결과 측정
측정값 설명
기간
Overall survival (OS)
기간: From the date of randomisation until death from any cause. Assessed for approximately up to 59 months.

OS is defined as the time from the date of randomisation until death from any cause. Censoring (for patients who are not reported as having died) will occur at the date last known to be alive. Patients without post-randomisation information will be censored at the date of randomisation (plus 1 day).
From the date of randomisation until death from any cause. Assessed for approximately up to 59 months.
Incidence, nature and severity of adverse events according to CTCAE v5.
기간: From the date the patient has signed the Informed Consent until the trial end. Assessed for approximately up to 59 months.

All safety parameters will be summarised in tables to evaluate the toxicity/safety profile of the protocol treatment.
From the date the patient has signed the Informed Consent until the trial end. Assessed for approximately up to 59 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

ETOP IBCSG Partners Foundation

협력자

Regeneron Pharmaceuticals

수사관

  • 연구 의자: Ross Soo, MB BS, PhD, FRACP, National University Hospital, Singapore
  • 연구 의자: Patrick Forde, MD, MBBCh, PhD, Trinity St James Cancer Institute, Dublin, Ireland
  • 연구 의자: Servet Bölükbas, MHBA, FETCS, FEBTS, FCCP, Universitätsmedizin Essen - Ruhrlandklinik Lungenkrebszentrum am Westdeutsches Tumorzentrum (LWTZ), Essen, Germany

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 1월 12일

기본 완료 (추정된)

2029년 3월 1일

연구 완료 (추정된)

2029년 3월 1일

연구 등록 날짜

최초 제출

2025년 4월 2일

QC 기준을 충족하는 최초 제출

2025년 4월 9일

처음 게시됨 (실제)

2025년 4월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 26일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ETOP 27-23

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

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