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A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
Sponsor: AstraZeneca
Summary
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
Official title: An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
Key Details
Gender
All
Age Range
18 Years - 123 Years
Study Type
INTERVENTIONAL
Enrollment
454
Start Date
2021-10-28
Completion Date
2027-07-30
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
Trastuzumab Deruxtecan
Trastuzumab Deruxtecan administered by intravenous infusion
Cisplatin
Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion
Carboplatin
Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion
Pembrolizumab
Pembrolizumab administered by intravenous infusion
Pemetrexed
Pemetrexed administered by intravenous infusion
Locations (130)
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Anchorage, Alaska, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Santa Monica, California, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Basking Ridge, New Jersey, United States
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Middletown, New Jersey, United States
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Montvale, New Jersey, United States
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New Brunswick, New Jersey, United States
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Commack, New York, United States
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Harrison, New York, United States
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New York, New York, United States
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Uniondale, New York, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Linz, Austria
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Vienna, Austria
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Ghent, Belgium
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Leuven, Belgium
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Barretos, Brazil
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Blumenau, Brazil
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Brasília, Brazil
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Natal, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Uberlândia, Brazil
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Vancouver, British Columbia, Canada
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Brampton, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Changsha, China
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Chengdu, China
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Fuzhou, China
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Guangzhou, China
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Hangzhou, China
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Jinan, China
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Kunming, China
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Kunming, China
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Linhai, China
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Nanchang, China
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Nanjing, China
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Shanghai, China
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Shenyang, China
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Shenzhen, China
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Wenzhou, China
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Wuhan, China
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Xi'an, China
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Xiamen, China
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Yangzhou, China
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Vejle, Denmark
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Bordeaux, France
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Dijon, France
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Le Mans, France
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Lyon, France
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Marseille, France
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Nantes, France
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Toulouse, France
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Villejuif, France
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Cologne, Germany
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Dresden, Germany
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Mainz, Germany
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München, Germany
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Oldenburg, Germany
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Jordan, Hong Kong
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Bangalore, India
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Delhi, India
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Hyderabad, India
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Mumbai, India
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Nashik, India
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Milan, Italy
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Monza, Italy
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Orbassano, Italy
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Parma, Italy
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Roma, Italy
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Verona, Italy
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Chūōku, Japan
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Fukuoka, Japan
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Kashiwa, Japan
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Matsuyama, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
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Osakasayama-shi, Japan
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Sapporo, Japan
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Sendai, Japan
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Sunto-gun, Japan
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Yokohama, Japan
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Yonago-shi, Japan
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Mexico City, Mexico
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Mexico City, Mexico
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Amsterdam, Netherlands
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Groningen, Netherlands
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Nijmegen, Netherlands
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Gdansk, Poland
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Olsztyn, Poland
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Przemyśl, Poland
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Warsaw, Poland
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Cheongju-si, South Korea
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Goyang-si, South Korea
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Gyeonggi-do, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Málaga, Spain
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Valencia, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Tainan, 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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Çankaya, Turkey (Türkiye)
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Edirne, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kadıkoy/Istanbul, Turkey (Türkiye)