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 - TROPION-Lung12

Inclusion Criteria

• 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