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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
Sponsor: AstraZeneca
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 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.
Official title: A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-10-15
Completion Date
2027-06-30
Last Updated
2026-01-27
Healthy Volunteers
No
Conditions
Interventions
Datopotamab Deruxtecan
Datopotamab Deruxtecan IV (intravenous)
Rilvegostomig
Rilvegostomig IV (intravenous)
Carboplatin
Carboplatin IV (intravenous), Active Comparator
Cisplatin
Cisplatin IV (intravenous), Active Comparator
Etoposide
Etoposide IV (intravenous), Active Comparator
Pemetrexed
Pemetrexed IV (intravenous), Active Comparator
Vinorelbine
Vinorelbine IV (intravenous), Active Comparator
UFT
UFT Oral route of administration, Active Comparator
Locations (99)
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Tucson, Arizona, United States
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Duarte, California, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Lone Tree, Colorado, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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St. Petersburg, Florida, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Zion, Illinois, United States
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Kansas City, Kansas, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Farmington Hills, Michigan, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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East Syracuse, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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Portland, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Fairfax, Virginia, United States
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Edmonds, Washington, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Barretos, Brazil
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Brasília, Brazil
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Florianópolis, Brazil
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São Paulo, Brazil
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Teresina, Brazil
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Halifax, Nova Scotia, Canada
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Oshawa, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Hong Kong, Hong Kong
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Bunkyō City, Japan
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Chiba, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Hidaka-shi, Japan
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Hiroshima, Japan
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Hiroshima, Japan
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Iwakuni-shi, Japan
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Kashiwa, Japan
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Kitaadachi-gun, Japan
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Kobe, Japan
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Kōtoku, Japan
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Kumamoto, Japan
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Nagoya, Japan
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Niigata, Japan
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Osakasayama-shi, Japan
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Sapporo, Japan
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Sendai, Japan
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Sendai, Japan
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Wakayama, Japan
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Yokohama, Japan
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Kuala Lumpur, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Kaohsiung City, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Bangkoknoi, Thailand
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Banphaeo, Thailand
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Dusit, Thailand
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Hat Yai, Thailand
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Muang, Thailand
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Muang, Thailand
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Ratchathewi, Thailand
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Mersin, Turkey (Türkiye)
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Leeds, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Da Nang, Vietnam
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Hanoi, Vietnam
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Hà Nội, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Vinh, Vietnam