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Un estudio clínico para evaluar la eficacia de la inmunoterapia adyuvante con cemiplimab en pacientes con cáncer de pulmón de células no pequeñas eliminadas quirúrgicamente que no han recibido quimioterapia previa. (ARCH)

26 de octubre de 2026 actualizado por: ETOP IBCSG Partners Foundation

Un ensayo aleatorizado de fase III de cemiplimab adyuvante en pacientes con NSCLC de estadio IIIA resecado que no han recibido quimioterapia adyuvante previa

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%.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

390

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Susanne Roux
  • Número de teléfono: +41 31 511 94 00
  • Correo electrónico: ARCH@etop.ibcsg.org

Ubicaciones de estudio

  • Alemania
  • Austria
  • España
      • A Coruña, España
      • Alicante, España
        • Reclutamiento
        • Hospital General Universitario Dr. Balmis de Alicante
        • Contacto:
      • Barakaldo, España
      • Barcelona, España
        • Reclutamiento
        • Hospital de La Santa Creu I Sant Pau
        • Contacto:
      • Barcelona, España
        • Reclutamiento
        • Hospital Universitario Vall D'Hebron
        • Contacto:
      • Granada, España
        • Reclutamiento
        • Hospital Clínico San Cecilio de Granada
        • Contacto:
      • Jerez de la Frontera, España
        • Reclutamiento
        • Hospital Universitario de Jerez de La Frontera
        • Contacto:
      • Madrid, España
      • Santa Cruz de Tenerife, España
        • Reclutamiento
        • Hospital Universitario Nuestra Señora de Candelaria
        • Contacto:
      • Valencia, España
  • Estonia
  • Francia
  • Irlanda
      • Cork, Irlanda
        • Aún no reclutando
        • Cork University Hospital
        • Contacto:
          • Sinead Noonan
      • Dublin, Irlanda
      • Dublin, Irlanda
        • Reclutamiento
        • St James's Hospital
        • Contacto:
      • Dublin, Irlanda
        • Aún no reclutando
        • St. Vincent's University Hospital
        • Contacto:
          • Sarah Lochrin
  • Italia
      • Meldola, Italia
        • Reclutamiento
        • IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
        • Contacto:
      • Milan, Italia
      • Milan, Italia
        • Reclutamiento
        • Instituto Europeo di Oncologia (IEO)
        • Contacto:
      • Novara, Italia
      • Pavia, Italia
        • Reclutamiento
        • Fondazione IRCCS Policlinico S. Matteo
        • Contacto:
      • Perugia, Italia
      • Prato, Italia
        • Reclutamiento
        • Nuovo Ospedale di Prato Santo Stefano
        • Contacto:
          • Daniele Pozzessere
      • Siena, Italia
        • Aún no reclutando
        • Azienda ospedaliero-universitaria Senese Siena
        • Contacto:
      • Treviso, Italia
      • Verona, Italia
        • Reclutamiento
        • Azienda Ospedaliera Universitaria Integrata di Verona
        • Contacto:
  • Singapur
      • Singapore, Singapur
        • Reclutamiento
        • National University Hospital
        • Contacto:
  • Suiza
      • Basel, Suiza
        • Reclutamiento
        • University Hospital Basel
        • Contacto:
      • Winterthur, Suiza
        • Reclutamiento
        • Kantonsspital Winterthur
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: 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.
Sin intervención: Control Arm: Observation

Observation.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Disease-free survival (DFS)
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall survival (OS)
Periodo de tiempo: 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.
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

ETOP IBCSG Partners Foundation

Colaboradores

Regeneron Pharmaceuticals

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de enero de 2026

Finalización primaria (Estimado)

1 de marzo de 2029

Finalización del estudio (Estimado)

1 de marzo de 2029

Fechas de registro del estudio

Enviado por primera vez

2 de abril de 2025

Primero enviado que cumplió con los criterios de control de calidad

9 de abril de 2025

Publicado por primera vez (Actual)

17 de abril de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ETOP 27-23

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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