Active Not RecruitingPhase 3NCT06564844

A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Checked against the public recordLast updated Aug 18, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations90
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AstraZeneca
Interventions being studied
Drug: Datopotamab Deruxtecan; Drug: Rilvegostomig; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Drug: Pemetrexed; Drug: Vinorelbine; Drug: UFT
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Histologically documented treatment-naive Stage I (T \< 4 cm, AJCC 8th ed) adenocarcinoma NSCLC 2. Complete surgical resection (R0) of the primary NSCLC 3. Unequivocal no evidence of disease at post-surgical 4. 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) 5. ECOG of 0 or 1, life expectancy of \> 6 months and complete recovery after surgery 6. Adequate bone marrow reserve and organ function Exclusion Criteria: 1. Sensitizing EGFR mutation and/or ALK alteration 2. 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 3. Significant pulmonary function compromise 4. History of another primary malignancy within 3 years (with exceptions) 5. Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease 6. Active or prior documented autoimmune or inflammatory disorders (with exceptions) 7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled 8. History of active primary immunodeficiency 9. Clinically significant corneal disease

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Research SiteTucson, Arizona
  • Research SiteDuarte, California
  • Research SiteGlendale, California
  • Research SiteLos Angeles, California
  • Research SiteLone Tree, Colorado
  • Research SiteWashington D.C., District of Columbia
  • Research SiteJacksonville, Florida
  • Research SiteSt. Petersburg, Florida
  • Research SiteChicago, Illinois
  • Research SiteEvanston, Illinois
  • Research SiteZion, Illinois
  • Research SiteKansas City, Kansas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 18, 2026. Always confirm current availability with the study team.

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