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

Running, not enrolling · Phase 3

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT06564844

Run by

AstraZeneca

People needed

25

Starts

2024-10-15

Expected to finish

2027-06-30

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Duarte, California, United States
• Research Site — Glendale, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Lone Tree, Colorado, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Zion, Illinois, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Farmington Hills, Michigan, United States
• Research Site — Grand Rapids, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Billings, Montana, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — East Syracuse, New York, United States
• Research Site — Mineola, New York, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Portland, Oregon, United States
• Research Site — Bethlehem, Pennsylvania, United States
• Research Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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