NCT06564844Not yet recruitingPhase 3
A trial to learn how well Dato-DXd and rilvegostomig work and how safe they are in participants with stage I adenocarcinoma non-small cell lung cancer (NSCLC) after complete removal through surgery
A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer who are ctDNA-positive or Have High-risk Pathological Features (TROPION Lung12)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Dec 2025
Brief summary (registry, in English)
To demonstrate superiority of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC by assessment of DFS using BICR, following complete tumour resection, in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or have at least one high-risk pathological feature.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 119 (estimated)
- First submitted
- 14 Oct 2024
- Start date
- 15 Jan 2025
- Lead sponsor
- AstraZeneca AB
- Diseases
- Lung cancer
- NCT number
- NCT06564844
- EU CT number
- 2024-512195-35-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 119
- 47 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Other illness
- History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- History of another primary malignancy within 3 years (with exceptions)
- Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
- Active infection with tuberculosis, hepatitis A, B or C virus, or known HIV infection that is not well controlled
- History of active primary immunodeficiency
- Clinically significant corneal disease
Lab values
- Sensitizing EGFR mutation and/or ALK alteration
Other
- Significant pulmonary function compromise
Who the study is looking for
- Histologically documented treatment-naive Stage I (T < 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
- Complete surgical resection (R0) of the primary NSCLC
- Unequivocal no evidence of disease at post-surgical baseline scan
- Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)
- ECOG of 0 or 1, life expectancy of > 6 months and complete recovery after surgery
- Adequate bone marrow reserve and organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Not yet recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Not yet recruiting |
| HELIOS Klinikum Erfurt GmbH Coordinator of this site? Confirm its status | Erfurt | Germany | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Not yet recruiting |
| Asklepios Klinik Gauting GmbH Coordinator of this site? Confirm its status | Gauting | Germany | Not yet recruiting |
| Franziskus Hospital Harderberg Coordinator of this site? Confirm its status | Georgsmarienhuette | Germany | Not yet recruiting |
| SRH Wald-Klinikum Gera GmbH Coordinator of this site? Confirm its status | Gera | Germany | Not yet recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Giessen | Germany | Not yet recruiting |
| Vincentius-Diakonissen-Kliniken gAG Coordinator of this site? Confirm its status | Karlsruhe | Germany | Not yet recruiting |
| Klinikverbund Allgaeu gGmbH Coordinator of this site? Confirm its status | Kempten (Allgau) | Germany | Not yet recruiting |
| Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Coordinator of this site? Confirm its status | Muenster | Germany | Not yet recruiting |
| Klinikum Wuerzburg Mitte gGmbH Coordinator of this site? Confirm its status | Wuerzburg | Germany | Not yet recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Quironsalud Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Not yet recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Not yet recruiting |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Not yet recruiting |
| HIA Sainte Anne Coordinator of this site? Confirm its status | Toulon Cedex 9 | France | Not yet recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Not yet recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Not yet recruiting |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Not yet recruiting |
| Orszagos Koranyi Pulmonologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Not yet recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Not yet recruiting |
| University Of Szeged Coordinator of this site? Confirm its status | Deszk | Hungary | Not yet recruiting |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Gyongyos | Hungary | Not yet recruiting |
| Matrai Gyogyintezet Coordinator of this site? Confirm its status | Gyöngyös | Hungary | Not yet recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Not yet recruiting |
| Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Szekesfehervar | Hungary | Not yet recruiting |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Not yet recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Not yet recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Not yet recruiting |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| National Institute Of Tuberculosis And Lung Diseases Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.