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.
Recruiting now · Phase 3
Conditions studied: Non Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT06284317
- Run by
- ETOP IBCSG Partners Foundation
- People needed
- 290
- Starts
- 2025-01-15
- Expected to finish
- 2030-03-01
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Inselspital Bern — Bern, Switzerland (enrolling)
- Nepean Hospital — Penrith, New South Wales, Australia (enrolling)
- Royal North Shore Hospital — St Leonards, New South Wales, Australia (enrolling)
- Beaumont Hospital — Dublin, Ireland (enrolling)
- St James's Hospital — Dublin, Ireland (enrolling)
- Istituto Oncologico Veneto — Padova, Italy (enrolling)
- Istituto Nazionale Tumori "Regina Elena" — Rome, Italy (enrolling)
- Universita di Verona - Department of Medicine — Verona, Italy (enrolling)
- NKI — Amsterdam, Netherlands (enrolling)
- UMCU — Utrecht, Netherlands (enrolling)
- Universitätsspital Basel — Basel, Switzerland (enrolling)
- HFR Hôpital Fribourgeois — Fribourg, Switzerland (enrolling)
- Kantonsspital St.Gallen — Sankt Gallen, Switzerland (enrolling)
- Kantonsspital Winterthur — Winterthur, Switzerland (enrolling)
- Barts Health NHS Trust — London, United Kingdom (enrolling)
- Maidstone and Tunbridge Wells NHS Trust — Maidstone, United Kingdom (enrolling)
- Wythenshawe Hospital, Manchester University NHS Foundation Trust — Manchester, United Kingdom (enrolling)
- Eastern Health — Box Hill, Victoria, Australia (enrolling)
- Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
- Peter MacCallum Cancer Centre — Parkville, Victoria, Australia (enrolling)
- Wien AKH — Vienna, Austria (enrolling)
- Institut Jules Bordet - HUB — Anderlecht, Belgium (enrolling)
- Antwerp University Hospital — Antwerp, Belgium (enrolling)
- North Estonia Medical Centre Foundation — Talinn, Estonia (enrolling)
- CHU Angers — Angers, France (enrolling)
Full record on ClinicalTrials.gov
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