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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
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06564844.
