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.
- Registration Number
- NCT06284317
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 290
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Durvalumab Adjuvant durvalumab Protocol treatment in the adjuvant phase consists of adjuvant durvalumab
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) 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).
- Secondary Outcome Measures
Name Time Method DFS in patients with pCR 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).Overall survival (OS) in patients with/without pCR 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.DFS in patients with/without ctDNA clearance 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).
Time to recurrence (TTR) in patients with/without pCR 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.Time to treatment discontinuation (TTD) in patients with/without pCR 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).
Toxicity according to CTCAE v5.0 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.
Trial Locations
- Locations (42)
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
🇮🇹Padova, 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
Erasmus MC
🇳🇱Rotterdam, Netherlands
UMCU
🇳🇱Utrecht, Netherlands
Kantonsspital Baden
🇨ðŸ‡Baden, Switzerland
Universitätsspital Basel
🇨ðŸ‡Basel, Switzerland
Eoc - Iosi
🇨ðŸ‡Bellinzona, Switzerland
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
HFR Hôpital Fribourgeois
🇨ðŸ‡Fribourg, Switzerland
Kantonsspital St.Gallen
🇨ðŸ‡St.Gallen, Switzerland
Kantonsspital Winterthur
🇨ðŸ‡Winterthur, Switzerland
University Hospital Zurich
🇨ðŸ‡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