Actively Recruiting
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.
Led by ETOP IBCSG Partners Foundation · Updated on 2026-05-14
290
Participants Needed
42
Research Sites
267 weeks
Total Duration
On this page
Sponsors
E
ETOP IBCSG Partners Foundation
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-small cell lung cancer (NSCLC).
- Stage IIB to IIIB (T1-4 N0-2) lung cancer according to the 8th edition TNM staging system.
- Stage III assessment includes lymph node samples at bilateral level 4 and level 7 to exclude stage IIIB N3 disease.
- T4 tumors eligible only if defined by size greater than 7 cm.
- Known PD-L1 status tested locally with a validated assay, preferably Ventana PD-L1 (SP263).
- Absence of EGFR mutation or ALK translocation.
- Primary tumor must be resectable and patient functionally operable as assessed by local multidisciplinary tumor board.
- Adequate blood counts: hemoglobin ≥90 g/L, absolute neutrophil count ≥1.0 x 10^9/L, platelet count ≥75 x 10^9/L.
- Adequate kidney function: creatinine clearance >40 mL/min.
- Adequate liver function: ALT and AST ≤2.5 times institutional upper limit, total bilirubin ≤1.5 times institutional upper limit.
- ECOG performance status 0-1.
- Age 18 years or older at enrollment.
- Body weight over 30 kg.
- Life expectancy of at least 12 weeks.
- Women of childbearing potential must have negative pregnancy tests before enrollment and before first treatment.
- Signed informed consent prior to any study procedures.
- For randomisation: surgical resection completed with R0 or R1 resection, fit for adjuvant durvalumab, no metastatic disease, and available pathological response documentation.
You will not qualify if you...
- T4 tumors invading heart, great vessels, carina, trachea, esophagus, or spine.
- Prior or concurrent treatments for NSCLC.
- Previous immunotherapy treatments.
- Major surgery within 28 days before enrollment.
- History of allogenic organ transplantation.
- Active or prior autoimmune or inflammatory diseases except specific exceptions (e.g. vitiligo, type I diabetes, stable hypothyroidism).
- Uncontrolled illnesses such as active infection, symptomatic heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, or serious gastrointestinal conditions.
- Psychiatric or social conditions limiting compliance or consent ability.
- History of other primary malignancy unless treated curatively with no active disease for 5 years.
- History of leptomeningeal carcinomatosis or active primary immunodeficiency.
- Active hepatitis infection or uncontrolled HIV infection.
- Use of immunosuppressive medication within 14 days before first durvalumab dose, except certain low-dose or topical steroids.
- Receipt of live vaccines within 30 days before first durvalumab dose.
- Concurrent enrollment in another interventional clinical trial.
- Known allergy to durvalumab or excipients.
- Pregnant or breastfeeding women.
- Women of childbearing potential and sexually active men unwilling to use highly effective contraception during and 90 days after treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Not Yet Recruiting
2
Nepean Hospital
Penrith, New South Wales, Australia
Actively Recruiting
3
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Actively Recruiting
4
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Not Yet Recruiting
5
Flinders Medical Centre
Bedford Park, South Australia, Australia
Not Yet Recruiting
6
Royal Hobart Hospital
Hobart, Tasmania, Australia
Not Yet Recruiting
7
Eastern Health
Box Hill, Victoria, Australia
Actively Recruiting
8
Alfred Hospital
Melbourne, Victoria, Australia
Actively Recruiting
9
Peter MacCallum Cancer Centre
Parkville, Victoria, Australia
Actively Recruiting
10
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Not Yet Recruiting
11
Wien AKH
Vienna, Austria
Actively Recruiting
12
Institut Jules Bordet - HUB
Anderlecht, Belgium
Actively Recruiting
13
Antwerp University Hospital
Antwerp, Belgium
Actively Recruiting
14
North Estonia Medical Centre Foundation
Talinn, Estonia
Actively Recruiting
15
CHU Angers
Angers, France
Actively Recruiting
16
Institut Bergonié
Bordeaux, France
Actively Recruiting
17
Le Mans - CHG
Le Mans, France
Actively Recruiting
18
Lyon - Centre Léon Bérard
Lyon, France
Actively Recruiting
19
Beaumont Hospital
Dublin, Ireland
Actively Recruiting
20
St James's Hospital
Dublin, Ireland
Actively Recruiting
21
SS Antonio e Biagio e Cesare Arrigo Hospital
Alessandria, Italy
Not Yet Recruiting
22
Istituto Oncologico Veneto
Padova, Italy
Actively Recruiting
23
Perugia Hospital
Perugia, Italy
Not Yet Recruiting
24
Istituto Nazionale Tumori "Regina Elena"
Rome, Italy
Actively Recruiting
25
AOUS Policlinico Le Scotte
Siena, Italy
Not Yet Recruiting
26
Universita di Verona - Department of Medicine
Verona, Italy
Actively Recruiting
27
NKI
Amsterdam, Netherlands
Actively Recruiting
28
UMCU
Utrecht, Netherlands
Actively Recruiting
29
Kantonsspital Baden
Baden, Switzerland
Not Yet Recruiting
30
Universitätsspital Basel
Basel, Switzerland
Actively Recruiting
31
Eoc - Iosi
Bellinzona, Switzerland
Not Yet Recruiting
32
Inselspital Bern
Bern, Switzerland
Actively Recruiting
33
HFR Hôpital Fribourgeois
Fribourg, Switzerland
Actively Recruiting
34
CHUV
Lausanne, Switzerland
Not Yet Recruiting
35
Kantonsspital St.Gallen
Sankt Gallen, Switzerland
Actively Recruiting
36
Kantonsspital Winterthur
Winterthur, Switzerland
Actively Recruiting
37
University Hospital Zurich
Zurich, Switzerland
Not Yet Recruiting
38
Barts Health NHS Trust
London, United Kingdom
Actively Recruiting
39
Royal Marsden Hospital (Chelsea)
London, United Kingdom
Not Yet Recruiting
40
Royal Marsden Hospital (Sutton)
London, United Kingdom
Not Yet Recruiting
41
Maidstone and Tunbridge Wells NHS Trust
Maidstone, United Kingdom
Actively Recruiting
42
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
Research Team
H
Heidi Roschitzki, PhD
CONTACT
S
Susanne Roux
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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