Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06284317
Registration number
NCT06284317
Ethics application status
Date submitted
1/04/2024
Date registered
21/02/2024
Date last updated
4/04/2024
Titles & IDs
Public 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.
Query!
Scientific title
An International, Multicentre, Open-label Randomised Phase III Trial to Evaluate the Benefit of Adding Adjuvant Durvalumab After Neoadjuvant Chemotherapy Plus Durvalumab in Patients With Stage IIB-IIIB (N2) Resectable NSCLC
Query!
Secondary ID [1]
0
0
ETOP 25-23
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ADOPT-lung
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Adjuvant durvalumab
Experimental: Durvalumab - Protocol treatment in the adjuvant phase consists of adjuvant durvalumab
No Intervention: Observation - Observation only
Treatment: Drugs: 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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Disease-free survival (DFS)
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Query!
Secondary outcome [1]
0
0
Response rate as per investigator assessment.
Query!
Assessment method [1]
0
0
Assessed in the neoadjuvant treatment phase (before randomisation).
Rate of response to the neo-adjuvant treatment is defined as the percentage of enrolled
patients with complete or partial response by RECIST v1.1, as assessed by the
investigator before surgery (after neoadjuvant treatment).
Query!
Timepoint [1]
0
0
From the date of enrolment until randomisation (approximately 24 weeks after enrolment)
Query!
Secondary outcome [2]
0
0
Proportion of patients undergoing surgery
Query!
Assessment method [2]
0
0
Assessed in the neoadjuvant treatment phase (before randomisation).
Query!
Timepoint [2]
0
0
From the date of enrolment until randomisation (approximately 24 weeks after enrolment)
Query!
Secondary outcome [3]
0
0
Proportion of patients with surgical outcome R0 and R1
Query!
Assessment method [3]
0
0
Assessed in the neoadjuvant treatment phase (before randomisation).
Query!
Timepoint [3]
0
0
From the date of enrolment until randomisation (approximately 24 weeks after enrolment)
Query!
Secondary outcome [4]
0
0
pCR rate
Query!
Assessment method [4]
0
0
Assessed in the neoadjuvant treatment phase (before randomisation).
pCR rate is defined as the percentage of enrolled patients with absence of viable tumour
cells after full pathologic examination of the resection (ypT0yN0M0).
Query!
Timepoint [4]
0
0
From the date of enrolment until randomisation (approximately 24 weeks after enrolment)
Query!
Secondary outcome [5]
0
0
Proportion of patients eligible for randomisation
Query!
Assessment method [5]
0
0
Assessed in the neoadjuvant treatment phase (before randomisation).
Query!
Timepoint [5]
0
0
From the date of enrolment until randomisation (approximately 24 weeks after enrolment)
Query!
Secondary outcome [6]
0
0
Proportion of patients effectively randomised
Query!
Assessment method [6]
0
0
Assessed in the neoadjuvant treatment phase (before randomisation).
Query!
Timepoint [6]
0
0
From the date of enrolment until randomisation (approximately 24 weeks after enrolment)
Query!
Secondary outcome [7]
0
0
Toxicity according to CTCAE v5.0
Query!
Assessment method [7]
0
0
Assessed in the neoadjuvant treatment phase (before 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.
Query!
Timepoint [7]
0
0
From the date of enrolment until randomisation (approximately 24 weeks after enrolment)
Query!
Secondary outcome [8]
0
0
DFS in patients with pCR
Query!
Assessment method [8]
0
0
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).
Query!
Timepoint [8]
0
0
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Query!
Secondary outcome [9]
0
0
Overall survival (OS) in patients with/without pCR
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Query!
Secondary outcome [10]
0
0
DFS in patients with/without ctDNA clearance
Query!
Assessment method [10]
0
0
Assessed in the adjuvant treatment phase (after randomisation).
Query!
Timepoint [10]
0
0
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Query!
Secondary outcome [11]
0
0
Time to recurrence (TTR) in patients with/without pCR
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Query!
Secondary outcome [12]
0
0
Time to treatment discontinuation (TTD) in patients with/without pCR
Query!
Assessment method [12]
0
0
Assessed in the adjuvant treatment phase (after randomisation).
Query!
Timepoint [12]
0
0
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Query!
Secondary outcome [13]
0
0
Toxicity according to CTCAE v5.0
Query!
Assessment method [13]
0
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.
Query!
Timepoint [13]
0
0
From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
Query!
Eligibility
Key inclusion criteria
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
1/10/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/03/2030
Query!
Actual
Query!
Sample size
Target
290
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
ETOP IBCSG Partners Foundation
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06284317
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Solange Peters, MD-PhD
Query!
Address
0
0
Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Heidi Roschitzki, PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+41 31 511 94 00
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT06284317
Download to PDF