Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Antineoplastic Agents, Immunological

Protocol treatment in the adjuvant phase consists of 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.

Adjuvant durvalumab

Heidi Roschitzki, PhD

Susanne Roux

Solange Peters, MD-PhD

Sabine Schmid, MD

Paul Van Schil, MD-PhD

Stephen Finn, MD-PhD

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.

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.

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

Outcome (OS) in patients with patients with either

* ctDNA clearance after neoadjuvant treatment but not achieving pCR
* no ctDNA clearance after neoadjuvant treatment but achieving pCR

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

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).

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).

Assessed in the neoadjuvant treatment phase (before randomisation).

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).

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.

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).

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.

Assessed in the adjuvant treatment phase (after randomisation).

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.

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.

Spots Global Cancer Trial Database for adjuvant durvalumab