癌研連線CancerLink
Active, not recruiting NCT06564844

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

Non-Small Cell Lung CancerPhase 3Stage IEGFRALK

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.

Conditions: Non-small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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

Exclusion Criteria

  • Sensitizing EGFR mutation and/or ALK alteration
  • 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
  • Significant pulmonary function compromise
  • 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 or prior documented autoimmune or inflammatory disorders (with exceptions)
  • Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled
  • History of active primary immunodeficiency
  • Clinically significant corneal disease

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.