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以前の化学療法を受けていない外科的に除去された非小細胞肺癌患者における補助免疫療法の有効性を評価する臨床研究。 (ARCH)

2026年10月26日 更新者：ETOP IBCSG Partners Foundation

以前のアジュバント化学療法を受けていない切除されたII-IIIA NSCLC患者における補助セミプリマブの無作為化第III相試験

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%.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

390

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アイルランド
      • Cork、アイルランド
        • まだ募集していません
        • Cork University Hospital
        • コンタクト：
          • Sinead Noonan
      • Dublin、アイルランド
      • Dublin、アイルランド
        • 募集
        • St James's Hospital
        • コンタクト：
      • Dublin、アイルランド
        • まだ募集していません
        • St. Vincent's University Hospital
        • コンタクト：
          • Sarah Lochrin
  • イタリア
      • Meldola、イタリア
        • 募集
        • IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
        • コンタクト：
      • Milan、イタリア
      • Milan、イタリア
        • 募集
        • Instituto Europeo di Oncologia (IEO)
        • コンタクト：
      • Novara、イタリア
      • Pavia、イタリア
        • 募集
        • Fondazione IRCCS Policlinico S. Matteo
        • コンタクト：
      • Perugia、イタリア
      • Prato、イタリア
        • 募集
        • Nuovo Ospedale di Prato Santo Stefano
        • コンタクト：
          • Daniele Pozzessere
      • Siena、イタリア
        • まだ募集していません
        • Azienda ospedaliero-universitaria Senese Siena
        • コンタクト：
      • Treviso、イタリア
      • Verona、イタリア
        • 募集
        • Azienda Ospedaliera Universitaria Integrata di Verona
        • コンタクト：
  • エストニア
  • オーストリア
  • シンガポール
      • Singapore、シンガポール
  • スイス
      • Basel、スイス
        • 募集
        • University Hospital Basel
        • コンタクト：
      • Winterthur、スイス
  • スペイン
      • A Coruña、スペイン
      • Alicante、スペイン
        • 募集
        • Hospital General Universitario Dr. Balmis de Alicante
        • コンタクト：
      • Barakaldo、スペイン
      • Barcelona、スペイン
        • 募集
        • Hospital de La Santa Creu I Sant Pau
        • コンタクト：
      • Barcelona、スペイン
        • 募集
        • Hospital Universitario Vall D'Hebron
        • コンタクト：
      • Granada、スペイン
        • 募集
        • Hospital Clínico San Cecilio de Granada
        • コンタクト：
      • Jerez de la Frontera、スペイン
        • 募集
        • Hospital Universitario de Jerez de La Frontera
        • コンタクト：
      • Madrid、スペイン
      • Santa Cruz de Tenerife、スペイン
        • 募集
        • Hospital Universitario Nuestra Señora de Candelaria
        • コンタクト：
      • Valencia、スペイン
  • ドイツ
  • フランス

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.
介入なし：Control Arm: Observation

Observation.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Disease-free survival (DFS)
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall survival (OS)
時間枠：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.
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

ETOP IBCSG Partners Foundation

協力者

Regeneron Pharmaceuticals

捜査官

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月12日

一次修了 (推定)

2029年3月1日

研究の完了 (推定)

2029年3月1日

試験登録日

最初に提出

2025年4月2日

QC基準を満たした最初の提出物

2025年4月9日

最初の投稿 (実際)

2025年4月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月28日

QC基準を満たした最後の更新が送信されました

2026年10月26日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ETOP 27-23

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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