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
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT06564844
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 660
Inclusion Criteria:<br><br> 1. Histologically documented treatment-naive Stage I (T < 4 cm, AJCC 8th ed)<br> adenocarcinoma NSCLC<br><br> 2. Complete surgical resection (R0) of the primary NSCLC<br><br> 3. Unequivocal no evidence of disease at post-surgical<br><br> 4. Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one<br> high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular<br> invasion (LVI), high-grade histology) (Stage IB only)<br><br> 5. ECOG of 0 or 1, life expectancy of > 6 months and complete recovery after surgery<br><br> 6. Adequate bone marrow reserve and organ function<br><br>Exclusion Criteria:<br><br> 1. Sensitizing EGFR mutation and/or ALK alteration<br><br> 2. History of non-infectious ILD/pneumonitis that required steroids, has current<br> ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by<br> imaging at screening<br><br> 3. Significant pulmonary function compromise<br><br> 4. History of another primary malignancy within 3 years (with exceptions)<br><br> 5. Any evidence of severe or uncontrolled systemic diseases, including but not limited<br> to bleeding diseases, active infection and cardiac disease<br><br> 6. Active or prior documented autoimmune or inflammatory disorders (with exceptions)<br><br> 7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known<br> HIV infection that is not well controlled<br><br> 8. History of active primary immunodeficiency<br><br> 9. Clinically significant corneal disease
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 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;Participant-reported physical function 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;Participant-reported GHS/QoL 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;Pharmacokinetics (PK);Pharmacokinetics (PK);Pharmacokinetics (PK);Immunogenicity