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NCT06284317: ADOPT-lung

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

Recruiting now Phase 3 Last updated 12 May 2026
What this trial tests

Phase 3 trial testing Adjuvant durvalumab in Non Small Cell Lung Cancer in 290 participants. Currently enrolling.

Timeline
15 January 2025
Primary endpoint
1 October 2029
1 March 2030

Quick facts

Lead sponsorETOP IBCSG Partners Foundation
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment290
Start date15 January 2025
Primary completion1 October 2029
Estimated completion1 March 2030
Sites42 locations across Australia, Austria, Belgium, Estonia, France, Ireland, Italy, Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

ETOP IBCSG Partners Foundation

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Role of ctDNA for Diagnosis and Histological Prediction in Early Stage Non-Small-Cell Lung Cancer: A Narrative Review.
    Sassorossi C, Evangelista J, Stefani A, Chiappetta M, et al · · 2025 · cited 8× · PMID 40218254 · DOI 10.3390/diagnostics15070904
  2. Utility and Future Perspectives of Circulating Tumor DNA Analysis in Non-Small Cell Lung Cancer Patients in the Era of Perioperative Chemo-Immunotherapy.
    Ohara S, Suda K, Tsutani Y. · · 2025 · cited 3× · PMID 40940723 · DOI 10.3390/cells14171312
  3. Global advances and future directions in lung cancer care: expert consensus and strategic priorities.
    Meyer ML, Peters S, Jänne PA, Mok TS, et al · · 2026 · cited 1× · PMID 41579430 · DOI 10.1016/j.esmoop.2025.106034
  4. Neoadjuvant and perioperative immunotherapy in resectable non-small cell lung cancer: Evidence to date and remaining questions.
    Werner RS, Steinmann N, Opitz I. · · 2026 · PMID 41960128 · DOI 10.1016/j.xjon.2025.101577
  5. Perioperative chemo immunotherapy in non-small-cell lung cancer: what can we learn from the long-term results of NADIM?
    Fremand X, Onorati I, Duchemann B. · · 2025 · PMID 41367577 · DOI 10.21037/tlcr-2025-883
  6. The role of immunotherapy in resectable non-small-cell lung cancer.
    Moloney CD, Forde PM. · · 2025 · PMID 40861315 · DOI 10.1177/17588359251361883
  7. Advances and Future Perspectives for the Management of Non-Small Cell Lung Cancer in Australia: A Narrative Review.
    Brown LJ, Meredith G, Gao B, Ding P, et al · · 2026 · PMID 40851511 · DOI 10.1111/ajco.70001
  8. Curative immunotherapy-based strategies for non-metastatic non-small cell lung cancer.
    Kuhlman JJ, Li S, Manochakian R, Lou Y, et al · · 2024 · PMID 39764421 · DOI 10.37349/etat.2024.00281

Verify or expand the search:

Other recruiting trials for Non Small Cell Lung Cancer

Currently open trials in the same condition.

Other ETOP IBCSG Partners Foundation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06284317.

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