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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
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.
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
NOT_YET_RECRUITINGNepean Hospital
Penrith, New South Wales, Australia
RECRUITINGRoyal North Shore Hospital
St Leonards, New South Wales, Australia
RECRUITINGPrincess Alexandra Hospital
Woolloongabba, Queensland, Australia
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).
Time frame: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
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).
Time frame: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
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.
Time frame: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
DFS in patients with/without ctDNA clearance
Assessed in the adjuvant treatment phase (after randomisation).
Time frame: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
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.
Time frame: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Time to treatment discontinuation (TTD) in patients with/without pCR
Assessed in the adjuvant treatment phase (after randomisation).
Time frame: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
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.
Time frame: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Flinders Medical Centre
Bedford Park, South Australia, Australia
NOT_YET_RECRUITINGRoyal Hobart Hospital
Hobart, Tasmania, Australia
NOT_YET_RECRUITINGEastern Health
Box Hill, Victoria, Australia
RECRUITINGAlfred Hospital
Melbourne, Victoria, Australia
RECRUITINGPeter MacCallum Cancer Centre
Parkville, Victoria, Australia
RECRUITINGSir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
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