Non-small Cell Lung Cancer
Conditions
Interventions
Arm 1: Dato-DXd in Combination With Rilvegostomig
Participants in the Dato-DXd in combination with rilvegostomig group will receive 6 mg/kg
Dato-DXd plus 750 mg rilvegostomig as IV infusions q3w of D1
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
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 and complete recovery after surgery 6. Adequate bone marrow reserve and organ function
Exclusion criteria
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 8. History of active primary immunodeficiency 9. Clinically significant corneal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Disease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC [Time Frame: From date of randomisation up to approximately 10 years.] The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. _The measure of interest is the HR of DFS. Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components. | — |
Countries
Australia, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Japan, Malaysia, Netherlands, Norway, Poland, South Korea, Spain, Sweden
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed