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

Korábbi kezelés

• Active or prior documented autoimmune or inflammatory disorders (with exceptions)

Más betegség

• 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
• 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 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

Laborértékek

• Sensitizing EGFR mutation and/or ALK alteration

Egyéb

• Significant pulmonary function compromise

• 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