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Non Small Cell Lung CancerPhase 3ADOPT-lungNCT06284317

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

A Phase 3 study testing Adjuvant durvalumab in people with Non Small Cell Lung Cancer, run by ETOP IBCSG Partners Foundation at 42 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Adjuvant durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
42 sitesin 10 countries
Study dates
15 Jan 2025to Mar 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

42 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Heidi Roschitzki, PhD contact

+41 31 511 94 00

heidi.roschitzki@etop.ibcsg.org

Susanne Roux contact

+41 31 511 94 00

ADOPT-lung@etop.ibcsg.org

42 sites in 10 countries

Australia10 sites, 10 recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia

    Chris Karapetis

    Not yet recruiting

  • Eastern Health

    Box Hill, Victoria

    Phillip Parente

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales

    Malinda Itchins

    Not yet recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania

    Rebecca Tay

    Not yet recruiting

  • Alfred Hospital

    Melbourne, Victoria

    Maggie Moore

    Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia

    Samantha Bowyer

    Not yet recruiting

  • Peter MacCallum Cancer Centre

    Parkville, Victoria

    Benjamin Solomon

    Recruiting

  • Nepean Hospital

    Penrith, New South Wales

    Deme Karikios

    Recruiting

  • Royal North Shore Hospital

    St Leonards, New South Wales

    Malinda Itchins

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

    Kenneth O'Bryne

    Not yet recruiting

Other trials in Australia

Switzerland9 sites, 9 recruiting

  • Kantonsspital Baden

    Baden

    Sacha Rothschild, sacha.rothschild@ksb.ch

    Not yet recruiting

  • Universitätsspital Basel

    Basel

    David König, david.koenig@usb.ch

    Recruiting

  • Eoc - Iosi

    Bellinzona

    Martina Imbimbo, martina.imbimbo@eoc.ch

    Not yet recruiting

  • Inselspital Bern

    Bern

    Sabine Schmid, sabine.schmid@insel.ch

    Recruiting

  • HFR Hôpital Fribourgeois

    Fribourg

    Adrienne Bettini, Adrienne.Bettini@h-fr.ch

    Recruiting

  • CHUV

    Lausanne

    Hasna Bouchaab, hasna.bouchaab@chuv.ch

    Not yet recruiting

  • Kantonsspital St.Gallen

    Sankt Gallen

    Martin Früh, Martin.frueh@kssg.ch

    Recruiting

  • Kantonsspital Winterthur

    Winterthur

    Laetitia Mauti, laetitia.mauti@ksw.ch

    Recruiting

  • University Hospital Zurich

    Zurich

    Isabelle Opitz, isabelle.schmitt-opitz@usz.ch

    Not yet recruiting

Other trials in Switzerland

Italy6 sites, 6 recruiting

  • SS Antonio e Biagio e Cesare Arrigo Hospital

    Alessandria

    Pier Luigi Piovano, plpiovano@ospedale.al.it

    Not yet recruiting

  • Istituto Oncologico Veneto

    Padova

    Laura Bonnano, laura.bonanno@iov.veneto.it

    Recruiting

  • Perugia Hospital

    Perugia

    Giulio Metro, giulio.metro@ospedale.perugia.it

    Not yet recruiting

  • Istituto Nazionale Tumori "Regina Elena"

    Rome

    Landi Lorenza, lorenza.landi@ifo.it

    Recruiting

  • AOUS Policlinico Le Scotte

    Siena

    Michele Maio, mmaiocro@gmail.com

    Not yet recruiting

  • Universita di Verona - Department of Medicine

    Verona

    Lorenzo Belluomini, lorenzo.belluomini@univr.it

    Recruiting

Other trials in Italy

United Kingdom5 sites, 5 recruiting

  • Barts Health NHS Trust

    London

    Adam Januszewski, adam.januszewski@nhs.net

    Recruiting

  • Royal Marsden Hospital (Chelsea)

    London

    Sanjay Popat, sanjay.popat@rmh.nhs.uk

    Not yet recruiting

  • Royal Marsden Hospital (Sutton)

    London

    Sanjay Popat, sanjay.popat@rmh.nhs.uk

    Not yet recruiting

  • Maidstone and Tunbridge Wells NHS Trust

    Maidstone

    Riyaz Shah, riyaz.shah@nhs.net

    Recruiting

  • Wythenshawe Hospital, Manchester University NHS Foundation Trust

    Manchester

    Igor Randulfe, yvonne.summers@nhs.net

    Recruiting

Other trials in United Kingdom

France4 sites, 4 recruiting

  • CHU Angers

    Angers

    Youssef Oulkhouir, Youssef.Oulkhouir@chu-angers.fr

    Recruiting

  • Institut Bergonié

    Bordeaux

    Sophie Cousin, s.cousin@bordeaux.unicancer.fr

    Recruiting

  • Le Mans - CHG

    Le Mans

    Camille Guguen, cguguen@ch-lemans.fr

    Recruiting

  • Lyon - Centre Léon Bérard

    Lyon

    Maurice Pérol, maurice.perol@lyon.unicancer.fr

    Recruiting

Other trials in France

Belgium2 sites, 2 recruiting

  • Institut Jules Bordet - HUB

    Anderlecht

    Mariana Brandao, mariana.brandao@hubruxelles.be

    Recruiting

  • Antwerp University Hospital

    Antwerp

    Reinier Wener

    Recruiting

Other trials in Belgium

Ireland2 sites, 2 recruiting

  • Beaumont Hospital

    Dublin

    Jarushka Naidoo, jarushkanaidoo@beaumont.ie

    Recruiting

  • St James's Hospital

    Dublin

    Patrick Forde, pforde1@jhmi.edu

    Recruiting

Other trials in Ireland

Netherlands2 sites, 2 recruiting

  • NKI

    Amsterdam

    Willemijn Theelen, w.theelen@nki.nl

    Recruiting

  • UMCU

    Utrecht

    W.K. de Jong, w.k.dejong-9@umcutrecht.nl

    Recruiting

Other trials in Netherlands

Austria1 site, 1 recruiting

  • Wien AKH

    Vienna

    Clemens Aigner, clemens.aigner@meduniwien.ac.at

    Recruiting

Other trials in Austria

Estonia1 site, 1 recruiting

  • North Estonia Medical Centre Foundation

    Talinn

    Kersti Oselin, Kersti.Oselin@regionaalhaigla.ee

    Recruiting

Other trials in Estonia

About this study

Official title: An International, Multicentre, Open-label Randomised Phase III Trial to Evaluate the Benefit of Adding Adjuvant Durvalumab After Neoadjuvant Chemotherapy Plus Durvalumab in Patients With Stage IIB-IIIB (N2) Resectable NSCLC

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.

Being tested
Adjuvant durvalumab
Keywords
IIB-IIIB (N2) resectable NSCLC, Durvalumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant durvalumabDrug

    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.

Study groups in NCT06284317
Study groupRoleWhat they receive
DurvalumabExperimentalProtocol treatment in the adjuvant phase consists of adjuvant durvalumab
Receives: Drug: Adjuvant durvalumab
ObservationNo interventionObservation only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS)

    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).

    Measured: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Secondary outcomes (6)

  1. DFS in patients with pCR

    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).

    Measured: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

  2. Overall survival (OS) in patients with/without pCR

    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.

    Measured: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

  3. DFS in patients with/without ctDNA clearance

    Assessed in the adjuvant treatment phase (after randomisation).

    Measured: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

  4. Time to recurrence (TTR) in patients with/without pCR

    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.

    Measured: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

  5. Time to treatment discontinuation (TTD) in patients with/without pCR

    Assessed in the adjuvant treatment phase (after randomisation).

    Measured: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

  6. Toxicity according to CTCAE v5.0

    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.

    Measured: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start15 Jan 2025
  3. Primary completionOct 2029 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06284317
Sponsor's protocol ID
ETOP 25-23
Acronym
ADOPT-lung
Status last verified
May 2026
First submitted
21 Feb 2024
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvant durvalumab in people with Non Small Cell Lung Cancer, run by ETOP IBCSG Partners Foundation at 42 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Australia, Switzerland, Italy, United Kingdom, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heidi Roschitzki, PhD (+41 31 511 94 00, heidi.roschitzki@etop.ibcsg.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) (time frame: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06284317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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