Fact CheckerSign in

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Antwerp University Hospital
Coordinator of this site? Confirm its status
EdegemBelgiumNot yet recruiting
JESSA Ziekenhuis
Coordinator of this site? Confirm its status
HasseltBelgiumNot yet recruiting
Universitaetsklinikum Bonn AöR
Coordinator of this site? Confirm its status
BonnGermanyNot yet recruiting
HELIOS Klinikum Erfurt GmbH
Coordinator of this site? Confirm its status
ErfurtGermanyNot yet recruiting
Universitaetsklinikum Essen (AoR)
Coordinator of this site? Confirm its status
EssenGermanyNot yet recruiting
Klinikum Esslingen GmbH
Coordinator of this site? Confirm its status
Esslingen am NeckarGermanyNot yet recruiting
Asklepios Klinik Gauting GmbH
Coordinator of this site? Confirm its status
GautingGermanyNot yet recruiting
Franziskus Hospital Harderberg
Coordinator of this site? Confirm its status
GeorgsmarienhuetteGermanyNot yet recruiting
SRH Wald-Klinikum Gera GmbH
Coordinator of this site? Confirm its status
GeraGermanyNot yet recruiting
Universitaetsklinikum Giessen und Marburg GmbH
Coordinator of this site? Confirm its status
GiessenGermanyNot yet recruiting
Vincentius-Diakonissen-Kliniken gAG
Coordinator of this site? Confirm its status
KarlsruheGermanyNot yet recruiting
Klinikverbund Allgaeu gGmbH
Coordinator of this site? Confirm its status
Kempten (Allgau)GermanyNot yet recruiting
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Coordinator of this site? Confirm its status
MuensterGermanyNot yet recruiting
Klinikum Wuerzburg Mitte gGmbH
Coordinator of this site? Confirm its status
WuerzburgGermanyNot yet recruiting
Hospital General Universitario Dr. Balmis
Coordinator of this site? Confirm its status
AlicanteSpainNot yet recruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
Hospital del Mar
Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Hospital Quironsalud Malaga
Coordinator of this site? Confirm its status
MálagaSpainNot yet recruiting
Hospital Clinico Universitario Lozano Blesa
Coordinator of this site? Confirm its status
ZaragozaSpainNot yet recruiting
Centre Hospitalier Universitaire D'Angers
Coordinator of this site? Confirm its status
AngersFranceNot yet recruiting
Institut Curie
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting
Centre Hospitalier Universitaire Rouen
Coordinator of this site? Confirm its status
Rouen CedexFranceNot yet recruiting
Hospital Foch
Coordinator of this site? Confirm its status
SuresnesFranceNot yet recruiting
HIA Sainte Anne
Coordinator of this site? Confirm its status
Toulon Cedex 9FranceNot yet recruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceNot yet recruiting
Semmelweis University
Coordinator of this site? Confirm its status
Budapest VIIIHungaryNot yet recruiting
Orszagos Onkologiai Intezet
Coordinator of this site? Confirm its status
Budapest XIIHungaryNot yet recruiting
Orszagos Koranyi Pulmonologiai Intezet
Coordinator of this site? Confirm its status
Budapest XIIHungaryNot yet recruiting
University of Debrecen
Coordinator of this site? Confirm its status
DebrecenHungaryNot yet recruiting
University Of Szeged
Coordinator of this site? Confirm its status
DeszkHungaryNot yet recruiting
Clinexpert Kft.
Coordinator of this site? Confirm its status
GyongyosHungaryNot yet recruiting
Matrai Gyogyintezet
Coordinator of this site? Confirm its status
GyöngyösHungaryNot yet recruiting
University of Pecs
Coordinator of this site? Confirm its status
PécsHungaryNot yet recruiting
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Coordinator of this site? Confirm its status
SzekesfehervarHungaryNot yet recruiting
Református Pulmonológiai Centrum
Coordinator of this site? Confirm its status
TörökbálintHungaryNot yet recruiting
Careggi University Hospital
Coordinator of this site? Confirm its status
FlorenceItalyNot yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
Coordinator of this site? Confirm its status
MonzaItalyNot yet recruiting
Istituto Oncologico Veneto
Coordinator of this site? Confirm its status
PadovaItalyNot yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyNot yet recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
Coordinator of this site? Confirm its status
RomeItalyNot yet recruiting
Humanitas Mirasole S.p.A.
Coordinator of this site? Confirm its status
RozzanoItalyNot yet recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsNot yet recruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Coordinator of this site? Confirm its status
OlsztynPolandNot yet recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
Coordinator of this site? Confirm its status
PoznanPolandNot yet recruiting
National Institute Of Tuberculosis And Lung Diseases
Coordinator of this site? Confirm its status
WarsawPolandNot yet recruiting
Karolinska University Hospital
Coordinator of this site? Confirm its status
SolnaSwedenNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.