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.
- Conditions
- Stage IIB-IIIB (N2) resectable non small cell lung cancer
- Registration Number
- 2023-508773-82-00
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- Brief Summary
The primary objective of the study is to determine whether additional adjuvant immunotherapy 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 (Travis, Dacic et al. 2020).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruiting
- Sex
- Not specified
- Target Recruitment
- 335
Histologically confirmed NSCLC.
Primary tumour resectable and functionally operable as assessed per local multidisciplinary tumour board (cardiac evaluation, pulmonary function and diffusion capacity, comorbidity).
Patient has to be fit to receive at least one of the protocol-defined platinum-based chemotherapy regimens, as per local standards.
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.
Absence of EGFR mutation or ALK translocation, as tested locally.
Adequate haematological, renal, and liver function.
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.
T4 with invasion of heart, great vessels, carina, trachea, oesophagus, or spine.
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.
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
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.
History of leptomeningeal carcinomatosis.
History of active primary immunodeficiency.
Active hepatitis infection.
Known HIV infection that is not well-controlled.
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab.
Concurrent enrolment in another interventional clinical trial.
Known allergy or suspected hypersensitivity to durvalumab or its excipients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DFS in patients without pCR, measured from randomisation. DFS in patients without pCR, measured from randomisation.
- Secondary Outcome Measures
Name Time Method Assessed in the adjuvant treatment phase (after randomisation) • DFS in patients with pCR. • Overall survival (OS) in patients with/without pCR, ITT. • DFS in patients with/without ctDNA clearance. • Time to recurrence (TTR) in patients with/without pCR, ITT. • Time to treatment discontinuation (TTD) in patients with/without pCR, ITT. • Toxicity according to CTCAE v5.0. Assessed in the adjuvant treatment phase (after randomisation) • DFS in patients with pCR. • Overall survival (OS) in patients with/without pCR, ITT. • DFS in patients with/without ctDNA clearance. • Time to recurrence (TTR) in patients with/without pCR, ITT. • Time to treatment discontinuation (TTD) in patients with/without pCR, ITT. • Toxicity according to CTCAE v5.0.
Key secondary endpoint: (hierarchically tested) DFS in the ITT cohort (with and without pCR), measured from randomisation. Key secondary endpoint: (hierarchically tested) DFS in the ITT cohort (with and without pCR), measured from randomisation.
Trial Locations
- Locations (18)
Medical University Of Vienna
🇦🇹Vienna, Austria
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Institut Jules Bordet
🇧🇪Anderlecht, Belgium
Centre Leon Berard
🇫🇷Lyon, France
Centre Hospitalier Universitaire D'Angers
🇫🇷Angers, France
Centre Hospitalier Le Mans
🇫🇷Le Mans Cedex 9, France
Institut Bergonie
🇫🇷Bordeaux, France
I.F.O. Istituti Fisioterapici Ospitalieri
🇮🇹Rome, Italy
Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Scroll for more (8 remaining)Medical University Of Vienna🇦🇹Vienna, AustriaClemens AignerSite contact+4314040056445clemens.aigner@meduniwien.ac.at