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.
NCT ID: NCT06284317
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
290 participants
INTERVENTIONAL
2025-01-15
2030-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
NCT06564844
Durvalumab and Chemotherapy Induction Followed by Durvalumab and Radiotherapy in Large Volume Stage III NSCLC
NCT04765709
Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
NCT04092283
Survival Study of Docetaxel and Carboplatin as Neo-Adjuvant Vs Adjuvant Chemotherapy in Early Stage NSLC
NCT00321334
Immune Profiling of Stage III Non-small Cell Lung Cancer Patients Treated With Concurrent Chemoradiation and Adjuvant Durvalumab: A Prospective Observational Phase II Trial
NCT04432142
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Durvalumab
Protocol treatment in the adjuvant phase consists of adjuvant durvalumab
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.
Observation
Observation only
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
ETOP IBCSG Partners Foundation
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Solange Peters, MD-PhD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland
Sabine Schmid, MD
Role: STUDY_CHAIR
Inselspital, Universitätsspital Bern, 3010 Bern, Switzerland
Paul Van Schil, MD-PhD
Role: STUDY_CHAIR
Antwerp University Hospital, Antwerp, Belgium,
Stephen Finn, MD-PhD
Role: STUDY_CHAIR
St. James's Hospital, Dublin 8, Ireland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Eastern Health
Box Hill, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre
Parkville, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Wien AKH
Vienna, , Austria
Institut Jules Bordet - HUB
Anderlecht, , Belgium
Antwerp University Hospital
Antwerp, , Belgium
North Estonia Medical Centre Foundation
Talinn, , Estonia
CHU Angers
Angers, , France
Institut Bergonié
Bordeaux, , France
Le Mans - CHG
Le Mans, , France
Lyon - Centre Léon Bérard
Lyon, , France
Beaumont Hospital
Dublin, , Ireland
St James's Hospital
Dublin, , Ireland
SS Antonio e Biagio e Cesare Arrigo Hospital
Alessandria, , Italy
Istituto Oncologico Veneto
Padua, , Italy
Perugia Hospital
Perugia, , Italy
Istituto Nazionale Tumori "Regina Elena"
Rome, , Italy
AOUS Policlinico Le Scotte
Siena, , Italy
Universita di Verona - Department of Medicine
Verona, , Italy
NKI
Amsterdam, , Netherlands
UMCU
Utrecht, , Netherlands
Kantonsspital Baden
Baden, , Switzerland
Universitätsspital Basel
Basel, , Switzerland
Eoc - Iosi
Bellinzona, , Switzerland
Inselspital Bern
Bern, , Switzerland
HFR Hôpital Fribourgeois
Fribourg, , Switzerland
CHUV
Lausanne, , Switzerland
Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Barts Health NHS Trust
London, , United Kingdom
Royal Marsden Hospital (Chelsea)
London, , United Kingdom
Royal Marsden Hospital (Sutton)
London, , United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, , United Kingdom
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Malinda Itchins
Role: primary
Deme Karikios
Role: primary
Malinda Itchins
Role: primary
Kenneth O'Bryne
Role: primary
Chris Karapetis
Role: primary
Rebecca Tay
Role: primary
Phillip Parente
Role: primary
Maggie Moore
Role: primary
Benjamin Solomon
Role: primary
Samantha Bowyer
Role: primary
Reinier Wener
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ETOP 25-23
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.