Tests datopotamab deruxtecan with rilvegostomig as first treatment for advanced lung cancer
Compares datopotamab deruxtecan with rilvegostomig against pembrolizumab in adults with advanced non-squamous lung cancer.
Plain-language title generated from the registry record
Registry title: Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
Key facts
- Where
- Berlin, Bonn, Cologne, Essen, Freiburg im Breisgau, Gauting, Hamburg, Heidelberg, Kempten (Allgau), Kiel, Koblenz, Munich, Nuremberg, Potsdam, and Ravensburg, GermanySee the 16 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-squamous non-small cell lung cancer that is locally advanced or has spread, has high PD-L1 expression (TC ≥ 50%), and has no targetable gene change. They have not yet had drug treatment for this stage.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-squamous non-small cell lung cancer, stage IIIB, IIIC or IV, that cannot be treated with surgery meant to remove all of the disease or with full chemoradiation. At least one lesion not previously irradiated that can be measured by RECIST 1.1. ECOG performance status of 0 or 1.
- Earlier treatment
- No earlier drug treatment for advanced or metastatic NSCLC.
- Biomarker or test result
- Tumour PD-L1 expression of TC ≥ 50%. No sensitising EGFR mutations, no ALK or ROS1 rearrangements, and no other known gene change that has an approved first-line targeted therapy. A tumour sample must be provided for PD-L1, TROP2 and other biomarker testing.
Main reasons for not taking part
- Squamous cell, mainly squamous, mixed small cell, or sarcomatoid NSCLC
- Another primary cancer within the last 3 years
- Past or current lung inflammation or interstitial lung disease (ILD/pneumonitis), with a few exceptions
- Active or past autoimmune or inflammatory disease, with some exceptions
- Brain metastases unless treated, stable and with no symptoms, or spinal cord compression, or leptomeningeal carcinomatosis
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- What was the PD-L1 result of your tumour test?
- Can you look after yourself and are you up and about most of the day?
- Has your cancer spread to the brain?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT06357533, who can take part
Where in Germany
- Vivantes MVZ GmbHBerlin, GermanyTaking people
- Johanniter GmbHBonn, GermanyTaking people
- MVZ fuer Haematologie und Onkologie Koeln Am Sachsenring GmbHCologne, GermanyTaking people
- KEM I Evang. Kliniken Essen-Mitte gGmbHEssen, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Asklepios Klinik Gauting GmbHGauting, GermanyTaking people
- Hamato-Onkologie HamburgHamburg, GermanyTaking people
- Katholisches Marienkrankenhaus gGmbHHamburg, GermanyTaking people
- Thoraxklinik Heidelberg gGmbHHeidelberg, GermanyTaking people
- Klinikverbund Allgaeu gGmbHKempten (Allgau), GermanyTaking people
- Staedtisches Krankenhaus Kiel GmbHKiel, GermanyTaking people
- Institut fuer Versorgungsforschung in der Onkologie GbRKoblenz, GermanyTaking people
- Muenchen Klinik gGmbHMunich, GermanyTaking people
- Klinikum NuernbergNuremberg, GermanyTaking people
- Klinikum Ernst von Bergmann gGmbHPotsdam, GermanyTaking people
- Studienzentrum Onkologie Ravensburg GmbHRavensburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06357533EU 2023-505077-32-00
- Record updated
- 28 October 2026
- Original description
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.Read full original descriptionShow less
A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Inclusion: Histologically or cytologically documented non-squamous NSCLC; Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation; Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies; Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers; Known tumour PD-L1 expression status defined as TC ≥ 50%; At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline; ECOG performance status of 0 or 1; Adequate bone marrow reserve and organ function.
Exclusion: Prior systemic therapy for advanced/metastatic NSCLC; Active or prior documented autoimmune or inflammatory disorders (with exceptions); Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants; Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant; History of another primary malignancy within 3 years; Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol; History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening; History of leptomeningeal carcinomatosis; Known clinically significant corneal disease; Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled; History of active primary immunodeficiency; Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage; Has significant pulmonary function compromise, as determined by the investigator.