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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

NCT06564844

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Non-small Cell Lung Cancer

Interventions: Datopotamab Deruxtecan, Rilvegostomig, Carboplatin, Cisplatin, Etoposide

Countries: United States, Brazil, Canada, Hong Kong, Japan, Malaysia, Taiwan, Thailand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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, life expectancy of \> 6 months and complete recovery after surgery
6. Adequate bone marrow reserve and organ function

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 controlled
8. History of active primary immunodeficiency
9. Clinically significant corneal disease

Locations (90)

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