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Um ensaio internacional, multicêntrico e aberto de fase III randomizado para avaliar o benefício da adição de durvalumabe adjuvante após quimioterapia neoadjuvante mais durvalumabe em pacientes com NSCLC ressecável em estágio IIB-IIIB (N2) (ADOPT-lung)

3 de novembro de 2026 atualizado por: ETOP IBCSG Partners Foundation

ADOPT-lung is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

290

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Austrália
    • New South Wales
      • Camperdown, New South Wales, Austrália
        • Ainda não está recrutando
        • Chris O'Brien Lifehouse
        • Contato:
          • Malinda Itchins
      • Penrith, New South Wales, Austrália
        • Recrutamento
        • Nepean Hospital
        • Contato:
          • Deme Karikios
      • St Leonards, New South Wales, Austrália
        • Recrutamento
        • Royal North Shore Hospital
        • Contato:
          • Malinda Itchins
    • Queensland
      • Woolloongabba, Queensland, Austrália
        • Ainda não está recrutando
        • Princess Alexandra Hospital
        • Contato:
          • Kenneth O'Bryne
    • South Australia
      • Bedford Park, South Australia, Austrália
        • Ainda não está recrutando
        • Flinders Medical Centre
        • Contato:
          • Chris Karapetis
    • Tasmania
      • Hobart, Tasmania, Austrália
        • Ainda não está recrutando
        • Royal Hobart Hospital
        • Contato:
          • Rebecca Tay
    • Victoria
      • Box Hill, Victoria, Austrália
        • Recrutamento
        • Eastern Health
        • Contato:
          • Phillip Parente
      • Melbourne, Victoria, Austrália
        • Recrutamento
        • Alfred Hospital
        • Contato:
          • Maggie Moore
      • Parkville, Victoria, Austrália
        • Recrutamento
        • Peter MacCallum Cancer Centre
        • Contato:
          • Benjamin Solomon
    • Western Australia
      • Nedlands, Western Australia, Austrália
        • Ainda não está recrutando
        • Sir Charles Gairdner Hospital
        • Contato:
          • Samantha Bowyer
  • Bélgica
      • Anderlecht, Bélgica
      • Antwerp, Bélgica
        • Recrutamento
        • Antwerp University Hospital
        • Contato:
          • Reinier Wener
  • Estônia
  • França
  • Holanda
  • Irlanda
  • Itália
      • Alessandria, Itália
        • Ainda não está recrutando
        • SS Antonio e Biagio e Cesare Arrigo Hospital
        • Contato:
      • Padova, Itália
      • Perugia, Itália
      • Rome, Itália
        • Recrutamento
        • Istituto Nazionale Tumori "Regina Elena"
        • Contato:
      • Siena, Itália
        • Ainda não está recrutando
        • AOUS Policlinico Le Scotte
        • Contato:
      • Verona, Itália
  • Reino Unido
      • Cardiff, Reino Unido
        • Recrutamento
        • Velindre University NHS Trust
        • Contato:
          • Paul Shaw
      • Glasgow, Reino Unido
        • Ainda não está recrutando
        • Beatson West of Scotland Cancer Centre NHS Greater Glasgow and Clyde
        • Contato:
          • Nicola Steele
      • London, Reino Unido
      • London, Reino Unido
        • Ainda não está recrutando
        • Royal Marsden Hospital (Chelsea)
        • Contato:
      • London, Reino Unido
        • Ainda não está recrutando
        • Royal Marsden Hospital (Sutton)
        • Contato:
      • Maidstone, Reino Unido
        • Recrutamento
        • Maidstone and Tunbridge Wells NHS Trust
        • Contato:
      • Manchester, Reino Unido
        • Recrutamento
        • Wythenshawe Hospital, Manchester University NHS Foundation Trust
        • Contato:
  • Suíça
      • Baden, Suíça
      • Basel, Suíça
      • Bellinzona, Suíça
      • Bern, Suíça
      • Fribourg, Suíça
      • Lausanne, Suíça
      • Sankt Gallen, Suíça
      • Winterthur, Suíça
      • Zurich, Suíça
  • Áustria

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria for enrolment:

  • Histologically confirmed NSCLC.
  • Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer.

Stage III assessment should include samples of lymph nodes at levels 4, bilaterally, and level 7 to rule out stage IIIB N3 disease.

T4 tumours will only be eligible if they are defined as T4 based only on their size (>7cm); any other reason will be considered ineligible.

  • Known PD-L1 status, as tested locally using a validated assay. To ensure comparability of results, it is strongly encouraged that PD-L1 testing is done with the Ventana PD-L1 (SP263) assay.
  • Absence of EGFR mutation or ALK translocation, as tested locally.
  • Primary tumour resectable and functionally operable as assessed per local multidisciplinary tumour board (cardiac evaluation, pulmonary function and diffusion capacity, comorbidity).
  • Adequate haematological function:

Haemoglobin ≥90 g/L, Absolute neutrophil count (ANC) ≥1.0× 109/L, Platelet count ≥75× 109/L.

- Adequate renal function: Measured creatinine clearance (CL) >40 mL/min or calculated CL >40 mL/min calculated by the Cockcroft-Gault.

- Adequate liver function: ALT and AST ≤2.5× institutional ULN, Total serum bilirubin ≤1.5× institutional ULN (patients with Gilbert's syndrome may be allowed to be enrolled after consultation with the Medical Affairs Team at the ETOP IBCSG Partners Foundation.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Age ≥18 at the time of enrolment.
  • Body weight >30 kg.
  • Life expectancy of at least 12 weeks.
  • Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test at screening before enrolment. Pregnancy test must be repeated within 3 days before the first dose of protocol treatment.
  • Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.

Eligibility Criteria for randomisation:

  • Surgical resection must have been completed. Note: Participants who have had only had segmentectomy or wedge resections are not eligible for randomisation.
  • Patients must have complete resection: R0 or R1 resection.
  • Patients must be fit to receive adjuvant treatment with durvalumab.
  • Patients must have no evidence of metastatic disease as assessed by CT scan.
  • Documentation of pathological response as per local review must be available.

Exclusion Criteria for enrolment:

  • T4 with invasion of heart, great vessels, carina, trachea, oesophagus, or spine.
  • Any previous or concurrent treatments for NSCLC.
  • Any previous immunotherapy.
  • Major surgical procedure (as per investigators assessment) within 28 days before enrolment.
  • History of allogenic organ transplantation.
  • Active or prior documented autoimmune disease or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:

Patients with vitiligo or alopecia. Patients with type I diabetes. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.

Any chronic skin condition that does not require systemic therapy. Patients without active disease in the last 5 years may be included but only after consultation with the Medical Affairs Team at the ETOP IBCSG Partners Foundation.

Patients with celiac disease controlled by diet alone.

  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease (ILD), or serious chronic gastrointestinal conditions associated with diarrhoea.
  • Psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • History of another primary malignancy except for:

Malignancy treated with curative-intent and with no known active disease 5 years before the first dose of durvalumab and of low potential risk for recurrence.

Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.

Adequately treated carcinoma in situ without evidence of disease.

  • History of leptomeningeal carcinomatosis.
  • History of active primary immunodeficiency.
  • Active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HbsAg) or HBV core antibody (anti-HBc).

Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HbsAg) are eligible.

Participants positive for HCV antibody are only eligible if polymerase chain reaction is negative for HCV RNA.

  • Known HIV infection that is not well-controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load for 3 months, CD4+ count of 500 cell per mm3, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 3 months on the same anti-HIV medication.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:

Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).

Systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent.

Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).

- Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab.

Note: Patients in the ADOPT-lung trial, should not receive live vaccine whilst receiving durvalumab and for up to 30 days after the last dose.

Concurrent enrolment in another interventional clinical trial.

  • Known allergy or suspected hypersensitivity to durvalumab or its excipients.
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
  • Female patients who are pregnant or in the period of lactation.
  • Female patients of childbearing potential and sexually active men who are not willing to use a highly effective contraceptive method during the trial until at least 90 days after the last dose of protocol treatment.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Durvalumab

Protocol treatment in the adjuvant phase consists of adjuvant durvalumab
Medicamento: Adjuvant durvalumab

Durvalumab is given at a fixed dose of 1500 mg i.v. every 4 weeks (±1 week) until relapse or unacceptable toxicity, for a maximum of 12 cycles after surgery.
Sem intervenção: Observation

Observation only

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Disease-free survival (DFS)
Prazo: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Assessed in the adjuvant treatment phase.

DFS is defined as the time 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. Censoring (for patients without recurrence/death) will occur at the date of last tumour assessment. Patients without a post-randomisation tumour assessment will be censored at the date of randomisation (plus 1 day). DFS will be assessed in patients without pCR (primary endpoint), as well as in patients with pCR (secondary endpoint) and in patients with/without ctDNA clearance (secondary endpoints).
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
DFS in patients with pCR
Prazo: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Assessed in the adjuvant treatment phase (after randomisation).

DFS is defined as the time 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. Censoring (for patients without recurrence/death) will occur at the date of last tumour assessment. Patients without a post-randomisation tumour assessment will be censored at the date of randomisation (plus 1 day). DFS will be assessed in patients without pCR (primary endpoint), as well as in patients with pCR (secondary endpoint) and in patients with/without ctDNA clearance (secondary endpoints).
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Overall survival (OS) in patients with/without pCR
Prazo: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Assessed in the adjuvant treatment phase (after randomisation).

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 when they were last known to be alive. Patients without post-randomisation information will be censored at the date of randomisation (plus 1 day). OS will be assessed in patients with/without pCR.
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
DFS in patients with/without ctDNA clearance
Prazo: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Assessed in the adjuvant treatment phase (after randomisation).
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Time to recurrence (TTR) in patients with/without pCR
Prazo: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Assessed in the adjuvant treatment phase (after randomisation).

TTR is defined as the time from the date of randomisation until disease recurrence. Censoring (for patients without recurrence) will occur at the date of the last tumour assessment. Patients without a post-randomisation tumour assessment will be censored at the date of randomisation (plus 1 day). TTR will be assessed in patients with/without pCR.
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Time to treatment discontinuation (TTD) in patients with/without pCR
Prazo: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Assessed in the adjuvant treatment phase (after randomisation).
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Toxicity according to CTCAE v5.0
Prazo: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Assessed in the adjuvant treatment phase (after randomisation).

All safety parameters will be summarised in tables to evaluate the toxicity/safety profile of the protocol treatment based on:

  • Adverse events according to CTCAE v5.0 (any-cause as well as treatment-related) including adverse events leading to dose interruptions, withdrawal of protocol treatment, and death.
  • Severe, serious, and selected adverse events.
  • Deaths.
  • Laboratory parameters and abnormalities, and vital signs.
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Correlation between ctDNA clearance and DFS
Prazo: From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)

Exploratory endpoint
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)
Correlation between ctDNA clearance and OS
Prazo: From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)

Exploratory endpoint
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)
Correlation between ctDNA clearance and initial PD-L1 assessment
Prazo: From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)

Exploratory endpoint
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)
Outcome (event-free survival)
Prazo: From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)

Outcome (EFS) in patients with patients with either

  • ctDNA clearance after neoadjuvant treatment but not achieving pCR
  • no ctDNA clearance after neoadjuvant treatment but achieving pCR
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)
Correlation of Outcome Disease-free survival (DFS)
Prazo: From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)

Correlation of Outcome (DFS) in patients with longitudinal ctDNA assessment
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)
Correlation of Outcome Overall survival (OS)
Prazo: From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)

Correlation of Outcome (OS) in patients with longitudinal ctDNA assessment
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)
pCRDescription of patients entering each phase (e.g., % surgery, % randomised)
Prazo: From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)

pCRDescription of patients entering each phase (e.g., % surgery, % randomised)
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

ETOP IBCSG Partners Foundation

Colaboradores

AstraZeneca

Investigadores

  • Cadeira de estudo: Solange Peters, MD-PhD, Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland
  • Cadeira de estudo: Sabine Schmid, MD, Inselspital, Universitätsspital Bern, 3010 Bern, Switzerland
  • Cadeira de estudo: Paul Van Schil, MD-PhD, Antwerp University Hospital, Antwerp, Belgium,
  • Cadeira de estudo: Stephen Finn, MD-PhD, St. James's Hospital, Dublin 8, Ireland

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de janeiro de 2025

Conclusão Primária (Estimado)

1 de outubro de 2029

Conclusão do estudo (Estimado)

1 de março de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

21 de fevereiro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de fevereiro de 2024

Primeira postagem (Real)

28 de fevereiro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ETOP 25-23

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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