New hope for lung cancer patients: immunotherapy after surgery may keep cancer away

NCT ID NCT06284317

Disease control Sponsor: ETOP IBCSG Partners Foundation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for people with a certain type of lung cancer (stage IIB-IIIB) that can be removed with surgery. Participants first get chemotherapy plus the immunotherapy drug durvalumab before surgery. After surgery, those whose cancer did not fully disappear are randomly assigned to receive more durvalumab or just be watched. The goal is to see if extra durvalumab helps keep the cancer from returning.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

42 sites in 10 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AOUS Policlinico Le Scotte
NOT_YET_RECRUITING

Siena, Italy
Alfred Hospital
RECRUITING

Melbourne, Victoria, Australia
Antwerp University Hospital
RECRUITING

Antwerp, Belgium
Barts Health NHS Trust
RECRUITING

London, United Kingdom
Beaumont Hospital
RECRUITING

Dublin, Ireland
CHU Angers
RECRUITING

Angers, France
CHUV
NOT_YET_RECRUITING

Lausanne, Switzerland
Chris O'Brien Lifehouse
NOT_YET_RECRUITING

Camperdown, New South Wales, Australia
Eastern Health
RECRUITING

Box Hill, Victoria, Australia
Eoc - Iosi
NOT_YET_RECRUITING

Bellinzona, Switzerland
Flinders Medical Centre
NOT_YET_RECRUITING

Bedford Park, South Australia, Australia
HFR Hôpital Fribourgeois
RECRUITING

Fribourg, Switzerland
Inselspital Bern
RECRUITING

Bern, Switzerland
Institut Bergonié
RECRUITING

Bordeaux, France
Institut Jules Bordet - HUB
RECRUITING

Anderlecht, Belgium
Istituto Nazionale Tumori "Regina Elena"
RECRUITING

Rome, Italy
Istituto Oncologico Veneto
RECRUITING

Padova, Italy
Kantonsspital Baden
NOT_YET_RECRUITING

Baden, Switzerland
Kantonsspital St.Gallen
RECRUITING

Sankt Gallen, Switzerland
Kantonsspital Winterthur
RECRUITING

Winterthur, Switzerland
Le Mans - CHG
RECRUITING

Le Mans, France
Lyon - Centre Léon Bérard
RECRUITING

Lyon, France
Maidstone and Tunbridge Wells NHS Trust
RECRUITING

Maidstone, United Kingdom
NKI
RECRUITING

Amsterdam, Netherlands
Nepean Hospital
RECRUITING

Penrith, New South Wales, Australia
North Estonia Medical Centre Foundation
RECRUITING

Talinn, Estonia
Perugia Hospital
NOT_YET_RECRUITING

Perugia, Italy
Peter MacCallum Cancer Centre
RECRUITING

Parkville, Victoria, Australia
Princess Alexandra Hospital
NOT_YET_RECRUITING

Woolloongabba, Queensland, Australia
Royal Hobart Hospital
NOT_YET_RECRUITING

Hobart, Tasmania, Australia
Royal Marsden Hospital (Chelsea)
NOT_YET_RECRUITING

London, United Kingdom
Royal Marsden Hospital (Sutton)
NOT_YET_RECRUITING

London, United Kingdom
Royal North Shore Hospital
RECRUITING

St Leonards, New South Wales, Australia
SS Antonio e Biagio e Cesare Arrigo Hospital
NOT_YET_RECRUITING

Alessandria, Italy
Sir Charles Gairdner Hospital
NOT_YET_RECRUITING

Nedlands, Western Australia, Australia
St James's Hospital
RECRUITING

Dublin, Ireland
UMCU
RECRUITING

Utrecht, Netherlands
Universita di Verona - Department of Medicine
RECRUITING

Verona, Italy
University Hospital Zurich
NOT_YET_RECRUITING

Zurich, Switzerland
Universitätsspital Basel
RECRUITING

Basel, Switzerland
Wien AKH
RECRUITING

Vienna, Austria
Wythenshawe Hospital, Manchester University NHS Foundation Trust
RECRUITING

Manchester, United Kingdom

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