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)
Status: Recruiting
Location: See all (228) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
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Gilbert
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Phoenix
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Prescott
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Tucson
California
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Duarte
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Fountain Valley
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Glendale
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Irvine
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Los Angeles
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Los Angeles
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Newport Beach
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Orange
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San Diego
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Santa Barbara
Colorado
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Aurora
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Lone Tree
Washington, D.c.
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Washington D.c.
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Washington D.c.
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Washington D.c.
Delaware
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Newark
Florida
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Clermont
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Fort Myers
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Jacksonville
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Miami
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Miami Beach
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Orange City
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Orlando
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St. Petersburg
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St. Petersburg
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West Palm Beach
Idaho
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Boise
Illinois
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Chicago
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Evanston
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Zion
Indiana
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Fort Wayne
Kansas
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Kansas City
Kentucky
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Lexington
Massachusetts
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Boston
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Boston
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Boston
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Worcester
Maryland
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Annapolis
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Baltimore
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Baltimore
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Baltimore
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Baltimore
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Frederick
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Silver Spring
Michigan
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Ann Arbor
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Dearborn
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Detroit
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Farmington Hills
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Grand Rapids
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Ypsilanti
Minnesota
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Duluth
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Minneapolis
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Rochester
Missouri
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St Louis
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Billings
North Carolina
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Durham
Nebraska
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Omaha
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Omaha
New Jersey
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Camden
Nevada
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Las Vegas
New York
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East Syracuse
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Mineola
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New York
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New York
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New York
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The Bronx
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White Plains
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Cincinnati
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Cincinnati
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Cleveland
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Cleveland
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Cleveland
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Cleveland
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Independence
Oregon
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Portland
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Portland
Pennsylvania
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Bethlehem
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Philadelphia
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Pittsburgh
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Pittsburgh
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Knoxville
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Memphis
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Nashville
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Austin
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Dallas
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Dallas
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Houston
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Houston
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San Antonio
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Webster
Utah
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Salt Lake City
Virginia
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Fairfax
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Fairfax
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Norfolk
Washington
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Edmonds
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Seattle
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Seattle
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Seattle
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Silverdale
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Vancouver
Wisconsin
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Madison
Other Locations
Australia
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Camperdown
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Murdoch
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Townsville
Belgium
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Edegem
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Hasselt
Brazil
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Barretos
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Brasília
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Florianópolis
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São Paulo
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Teresina
Canada
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Greenfield Park
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Halifax
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Montreal
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Newmarket
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Oshawa
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Saskatoon
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St. John's
France
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Angers
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Marseille
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Paris
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Rouen
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Suresnes
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Toulon
Germany
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Bonn
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Erfurt
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Essen
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Esslingen Am Neckar
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Gauting
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Georgsmarienhütte
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Gera
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Giessen
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Karlsruhe
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Kempten
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Lübeck
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Münster
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Würzburg
Hong Kong Special Administrative Region
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Hong Kong
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Hong Kong
Hungary
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Budapest
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Budapest
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Budapest
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Budapest
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Debrecen
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Deszk
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Gyöngyös - Mátraháza
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Pécs
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Törökbálint
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Zalaegerszeg
Italy
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Florence
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Monza
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Padua
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Roma
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Roma
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Rozzano
Japan
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Bunkyō City
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Chiba
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Chūōku
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Fukuoka
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Hidaka-shi
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Hiroshima
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Hiroshima
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Iwakuni-shi
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Kashiwa
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Kitaadachi-gun
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Kobe
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Kōtoku
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Kumamoto
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Nagoya
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Niigata
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Osakasayama-shi
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Sapporo
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Sendai
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Sendai
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Wakayama
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Yokohama
Malaysia
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George Town
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Kuala Lumpur
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Kuala Lumpur
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Kuala Selangor
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Kuching
Netherlands
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Rotterdam
Poland
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Olsztyn
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Poznan
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Warsaw
Republic of Korea
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Incheon
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Seoul
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Seoul
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Seoul
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Suwon
Spain
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Alicante
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Badalona
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Barcelona
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Madrid
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Málaga
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Zaragoza
Sweden
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Solna
Switzerland
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Zurich
Taiwan
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Kaohsiung City
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Taipei
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Taipei
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Taipei
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Taoyuan District
Thailand
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Bangkok
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Bangkoknoi
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Banphaeo
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Dusit
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Hat Yai
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Muang
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Muang
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Ratchathewi
Turkey
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Ankara
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Ankara
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Istanbul
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Mersin
United Kingdom
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Leeds
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London
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Nottingham
Viet Nam
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Da Nang
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Hà Nội
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Hanoi
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Ho Chi Minh City
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Ho Chi Minh City
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Vinh
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2035-01-19
Participants
Target number of participants: 660
Treatments
Experimental: Dato-DXd + rilvegostomig
Participants in the Dato-DXd in combination with rilvegostomig group will receive Dato-DXd and rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
Experimental: Rilvegostomig
Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
Active_comparator: Standard of Care (SoC)
Patients in SoC group will undergo observation or will receive Investigator's Choice of Chemotherapy (ICC).
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Daiichi Sankyo