Status:
RECRUITING
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
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 surgic...
Detailed Description
The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 19 2035
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT06564844
Start Date
October 15 2024
End Date
January 19 2035
Last Update
October 14 2025
Active Locations (228)
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1
Research Site
Gilbert, Arizona, United States, 85234
2
Research Site
Phoenix, Arizona, United States, 85054
3
Research Site
Prescott, Arizona, United States, 86301
4
Research Site
Tucson, Arizona, United States, 85724