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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.

ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorETOP IBCSG Partners Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed NSCLC.

Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adjuvant durvalumab

    Drug

    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.

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: DurvalumabExperimental treatment 1 intervention
Group B: ObservationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

1

Correlation between ctDNA clearance and DFS

Exploratory endpoint

Time frame
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)
2

Correlation between ctDNA clearance and OS

Exploratory endpoint

Time frame
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)
3

Correlation between ctDNA clearance and initial PD-L1 assessment

Exploratory endpoint

Time frame
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)
4

Outcome (event-free survival)

Outcome (EFS) in patients with patients with either * ctDNA clearance after neoadjuvant treatment but not achieving pCR * no ctDNA clearance after neoadjuvant treatment but achieving pCR

Time frame
From the date of screening until last patient last visit (approximately 60 months after randomisation of the first patient)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ETOP IBCSG Partners Foundation

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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