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A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: AstraZeneca
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
768
Start Date
2024-10-04
Completion Date
2028-09-27
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Dato-DXd
Dato-DXd will be administered as IV infusion.
Osimertinib
Osimertinib will be administered orally.
Pemetrexed
Pemetrexed will be administered as IV infusion.
Carboplatin
Carboplatin will be administered as IV infusion.
Cisplatin
Cisplatin will be administered as IV infusion.
Locations (211)
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Fayetteville, Arkansas, United States
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Fountain Valley, California, United States
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San Diego, California, United States
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Jacksonville, Florida, United States
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Kansas City, Missouri, United States
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New York, New York, United States
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Maumee, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Fitzroy, Australia
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Heidelberg, Australia
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Kogarah, Australia
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Liverpool, Australia
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Nedlands, Australia
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St Leonards, Australia
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Westmead, Australia
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Woolloongabba, Australia
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Charleroi, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Jette, Belgium
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Namur, Belgium
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Roeselare, Belgium
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Barretos, Brazil
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Betim, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Rio de Janeiro, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Brampton, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Baoding, China
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Bengbu, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Deyang, China
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Ganzhou, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hefei, China
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Hengyang, China
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Jinan, China
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Linyi, China
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Luoyang, China
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Luzhou, China
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Nanchang, China
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Nanjing, China
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Shanghai, China
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Shantou, China
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Shenyang, China
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Shenyang, China
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Tianjin, China
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Weifang, China
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Wuhan, China
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Zhengzhou, China
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Zhengzhou, China
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Zhengzhou, China
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Bordeaux, France
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Caen, France
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Lille, France
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Montpellier, France
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Nantes, France
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Paris, France
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Pessac, France
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Toulon Armees, France
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Toulouse, France
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Villejuif, France
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Berlin-Zehlendorf, Germany
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Essen, Germany
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Georgsmarienhütte, Germany
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Großhansdorf, Germany
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Hamburg, Germany
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Hamburg, Germany
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Löwenstein, Germany
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Nuremberg, Germany
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Athens, Greece
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Athens, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Hyderabad, India
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Kolhāpur, India
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Mumbai, India
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Namakkal, India