A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)
Status: Recruiting
Location: See all (302) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed non-squamous NSCLC.
• Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutations, which may include T790M).
• Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
• Less than or equal to (\<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
• At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate bone marrow reserve and organ function within 7 days before randomization.
Locations
United States
Arkansas
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Fayetteville
California
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Duarte
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Fountain Valley
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La Jolla
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Los Angeles
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San Diego
Colorado
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Colorado Springs
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Fort Collins
Florida
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Gainesville
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Jacksonville
Georgia
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Athens
Illinois
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Chicago
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Evanston
Kentucky
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Louisville
Massachusetts
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Boston
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Boston
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Boston
Maryland
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Baltimore
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Bethesda
Michigan
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Detroit
Missouri
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Kansas City
Nebraska
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Omaha
New Jersey
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Morristown
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Northfield
New York
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New York
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New York
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The Bronx
Ohio
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Maumee
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Philadelphia
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Pittsburgh
Tennessee
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Chattanooga
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Nashville
Virginia
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Fairfax
Washington
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Seattle
Other Locations
Australia
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Fitzroy
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Heidelberg
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Kogarah
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Liverpool
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Nedlands
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Port Macquarie
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St Leonards
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Westmead
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Woodville
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Woolloongabba
Belgium
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Charleroi
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Edegem
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Ghent
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Hasselt
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Jette
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La Louvière
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Leuven
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Namur
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Roeselare
Brazil
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Barretos
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Betim
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Blumenau
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Florianópolis
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Itajaí
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Pelotas
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Porto Alegre
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Porto Alegre
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Porto Alegre
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Rio De Janeiro
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Rio De Janeiro
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Rio De Janeiro
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São Paulo
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São Paulo
Canada
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Brampton
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Montreal
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Newmarket
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Québec
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Toronto
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Toronto
China
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Baoding
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Beijing
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Beijing
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Beijing
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Beijing
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Beijing
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Bengbu
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Changchun
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Changchun
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Changsha
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Chengdu
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Deyang
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Ganzhou
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Guangzhou
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Hangzhou
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Hangzhou
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Hefei
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Hengyang
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Huaian
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Jinan
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Linyi
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Luoyang
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Luzhou
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Nanchang
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Nanjing
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Shanghai
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Shantou
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Shenyang
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Shenyang
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Tianjin
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Tianjin
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Weifang
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Wuhan
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Zhengzhou
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Zhengzhou
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Zhengzhou
France
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Angers
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Avignon
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Bordeaux
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Caen
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Lille
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Montpellier
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Nantes
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Paris
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Paris
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Pessac
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Quimper
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Toulon Armees
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Toulouse
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Tours
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Villejuif
Germany
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Berlin
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Berlin-zehlendorf
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Bonn
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Essen
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Georgsmarienhütte
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Giessen
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Großhansdorf
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Hamburg
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Hamburg
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Heidelberg
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Kempten
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Löwenstein
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Oldenburg
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Athens
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Athens
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Athens
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Athens
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Heraklion
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Hong Kong
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Hong Kong
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India
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Naples
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Padova
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Perugia
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Verona
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Fukuoka
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Iruma-gun
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Iwakuni-shi
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Kobe
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Kōtoku
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Kumamoto
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Kyoto
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Matsuyama
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Nagoya
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Nagoya
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Niigata
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Osaka
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Osaka
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Ōsaka-sayama
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Sendai
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Sunto-gun
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Toyoake-shi
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Utsunomiya
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Wakayama
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Yokohama
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Yokohama
Malaysia
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Alor Star
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Cheras
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Johor Bahru
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Kuala Selangor
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Kuching
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Perai
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Petaling Jaya
Netherlands
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Amersfoort
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Harderwijk
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Rotterdam
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Zutphen
Philippines
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Bacolod
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Quezon
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San Juan City
Poland
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Lodz
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Olsztyn
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Poznan
Portugal
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Braga
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Lisbon
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Loures
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Porto
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Porto
Republic of Korea
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Busan
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Chungcheongbuk-do
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Goyang-si
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Gyeonggi-do
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Jinju
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
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Suwon
Romania
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Craiova
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Craiova
Singapore
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Singapore
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Singapore
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Singapore
Spain
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A Coruña
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Barakaldo
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Barcelona
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Barcelona
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El Palmar
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L'hospitalet De Llobregat
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Madrid
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Madrid
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Majadahonda
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Málaga
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Oviedo
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Palma De Mallorca
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Pamplona
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Santander
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Santiago De Compostela-coruña
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Seville
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Valencia
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Valencia
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Valladolid
Taiwan
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Changhua
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Kaohsiung City
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New Taipei City
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Taichung
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Taichung
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Tainan
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Tainan
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Taipei
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Taipei
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Taipei
Thailand
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Bangkok
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Bangkok
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Bangkok
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Chiang Mai
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Hat Yai
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Khon Kaen
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Pathum Thani
United Kingdom
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Birmingham
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Cambridge
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Glasgow
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Leicester
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London
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Manchester
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Middlesbrough
Viet Nam
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Hanoi
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2024-10-04
Estimated Completion Date:2028-09-27
Participants
Target number of participants:744
Treatments
Experimental: Group 1: Dato-DXd + Osimertinib Combination Therapy
Participants will receive Dato-DXd 6 milligrams per kilogram (mg/kg) as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of every 21-day cycle, and osimertinib 80 milligrams (mg) once daily (QD) orally, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.
Experimental: Group 2: Dato-DXd Monotherapy
Participants will receive Dato-DXd 6 mg/kg as IV infusion Q3W on Day 1 of every 21-day cycle, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.
Experimental: Group 3: Platinum-based Doublet Chemotherapy
Participants will receive pemetrexed 500 milligrams per meter square (mg/m2) in combination with carboplatin (AUC5) or cisplatin 75 mg/m2 as IV infusion Q3W for 4 cycles followed by pemetrexed maintenance 500 mg/m2 as IV infusion Q3W, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or another discontinuation criterion is met.