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
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06564844
This Phase III study evaluates the efficacy and safety of adjuvant Dato-DXd with rilvegostomig versus standard care in Stage I adenocarcinoma NSCLC patients post-surgery. Eligible participants are ctDNA-positive or have high-risk features. Interventions include Datopotamab Deruxtecan, Rilvegostomig, and various active comparators like Carboplatin and Cisplatin. Participants must have adequate organ function and recovery post-surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
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 surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
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 with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85234 | Gilbert | Arizona |
| Research Site | 85054 | Phoenix | Arizona |
| Research Site | 85710 | Tucson | Arizona |
| Research Site | 85719 | Tucson | Arizona |
| Research Site | 91010 | Duarte | California |
| Research Site | 92708 | Fountain Valley | California |
| Research Site | 91204 | Glendale | California |
| Research Site | 90033 | Los Angeles | California |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 92868 | Orange | California |
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