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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
Phase 3 trial testing Adjuvant durvalumab in Non Small Cell Lung Cancer in 290 participants. Currently enrolling.
1 October 2029
Quick facts
| Lead sponsor | ETOP IBCSG Partners Foundation |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 290 |
| Start date | 15 January 2025 |
| Primary completion | 1 October 2029 |
| Estimated completion | 1 March 2030 |
| Sites | 42 locations across Australia, Austria, Belgium, Estonia, France, Ireland, Italy, Netherlands |
Drugs / interventions tested
- Adjuvant durvalumab — full drug profile →
Conditions studied
- Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
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.
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Disease-free survival (DFS)
Time frame: From the date of randomisation until last patient last visit (approximately 60 months after randomisation of the first patient)
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 w
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):
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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 -
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 -
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 -
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 -
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 -
The role of immunotherapy in resectable non-small-cell lung cancer.
Moloney CD, Forde PM. · · 2025 · PMID 40861315 · DOI 10.1177/17588359251361883 -
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 -
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:
- PubMed search for NCT06284317
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non Small Cell Lung Cancer
Currently open trials in the same condition.
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Other ETOP IBCSG Partners Foundation trials
Trials by the same sponsor.
- NCT05718297 — Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer · Phase 2 · withdrawn
- NCT05896566 — A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients Wi · Phase 2 · completed
- NCT05601973 — Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progressio · Phase 2 · active not recruiting
- NCT04908956 — Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO) · Phase 2 · terminated
- NCT04245085 — ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06284317 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ETOP IBCSG Partners Foundation
- Last refreshed: 12 May 2026
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing