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Brief Title: 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
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)
Study ID: NCT05048797
Brief 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
Detailed Description: Eligible participants will be those diagnosed with unresectable, locally advanced or metastatic histologically documented non-squamous NSCLC with HER2 exons 19 or 20 mutations and who are treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease. The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) as compared with Standard of Care treatment (Investigator's choice of cisplatin or carboplatin + pembrolizumab + pemetrexed). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse or simply to live longer, compared to patients receiving standard of care treatment. This study is also looking to see how the treatment and the cancer affects patients' quality of life.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Anchorage, Alaska, United States
Research Site, Los Alamitos, California, United States
Research Site, Los Angeles, California, United States
Research Site, Orange, California, United States
Research Site, San Francisco, California, United States
Research Site, Santa Monica, California, United States
Research Site, Santa Rosa, California, United States
Research Site, Silver Spring, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Basking Ridge, New Jersey, United States
Research Site, East Brunswick, New Jersey, United States
Research Site, Middletown, New Jersey, United States
Research Site, Montvale, New Jersey, United States
Research Site, New Brunswick, New Jersey, United States
Research Site, Commack, New York, United States
Research Site, Harrison, New York, United States
Research Site, New York, New York, United States
Research Site, Uniondale, New York, United States
Research Site, Canton, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Dallas, Texas, United States
Research Site, Kennewick, Washington, United States
Research Site, La Crosse, Wisconsin, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, Graz, , Austria
Research Site, Innsbruck, , Austria
Research Site, Linz, , Austria
Research Site, Rankweil, , Austria
Research Site, Wien, , Austria
Research Site, Gent, , Belgium
Research Site, Hasselt, , Belgium
Research Site, Leuven, , Belgium
Research Site, Barretos, , Brazil
Research Site, Blumenau, , Brazil
Research Site, Brasília, , Brazil
Research Site, Florianópolis, , Brazil
Research Site, Natal, , Brazil
Research Site, Salvador, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Uberlândia, , Brazil
Research Site, Vancouver, British Columbia, Canada
Research Site, Brampton, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Fuzhou, , China
Research Site, Guangzhou, , China
Research Site, Hangzhou, , China
Research Site, Harbin, , China
Research Site, Jinan, , China
Research Site, Kunming, , China
Research Site, Kunming, , China
Research Site, Linhai, , China
Research Site, Nanchang, , China
Research Site, Nanjing, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shenyang, , China
Research Site, Shenyang, , China
Research Site, ShenZhen, , China
Research Site, Wenzhou, , China
Research Site, Wuhan, , China
Research Site, Xi'an, , China
Research Site, Xiamen, , China
Research Site, Yangzhou, , China
Research Site, Zhengzhou City, , China
Research Site, Vejle, , Denmark
Research Site, Bordeaux, , France
Research Site, Dijon, , France
Research Site, Le Mans Cedex, , France
Research Site, Lyon, , France
Research Site, Marseille cedex, , France
Research Site, Nantes, , France
Research Site, Rennes Cedex 9, , France
Research Site, Toulouse Cedex 9, , France
Research Site, Villejuif Cedex, , France
Research Site, Berlin-Zehlendorf, , Germany
Research Site, Dresden, , Germany
Research Site, Erfurt, , Germany
Research Site, Heidelberg, , Germany
Research Site, Immenhausen, , Germany
Research Site, Köln, , Germany
Research Site, Mainz, , Germany
Research Site, Mannheim, , Germany
Research Site, München, , Germany
Research Site, Oldenburg, , Germany
Research Site, Ravensburg, , Germany
Research Site, Würzburg, , Germany
Research Site, Hong Kong, , Hong Kong
Research Site, Jordan, , Hong Kong
Research Site, Shatin, , Hong Kong
Research Site, Bangalore, , India
Research Site, Delhi, , India
Research Site, Hyderabad, , India
Research Site, Mumbai, , India
Research Site, Nashik, , India
Research Site, Milan, , Italy
Research Site, Monza, , Italy
Research Site, Orbassano, , Italy
Research Site, Parma, , Italy
Research Site, Roma, , Italy
Research Site, Verona, , Italy
Research Site, Chuo-ku, , Japan
Research Site, Fukuoka-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Matsuyama-shi, , Japan
Research Site, Niigata-shi, , Japan
Research Site, Okayama-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osakasayama-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Yonago-shi, , Japan
Research Site, Cheongju-si, , Korea, Republic of
Research Site, Goyang-si, , Korea, Republic of
Research Site, Gyeonggi-do, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Cdmx, , Mexico
Research Site, Culiacán, , Mexico
Research Site, Guadalajara Jalisco, , Mexico
Research Site, Merida, , Mexico
Research Site, Mexico City, , Mexico
Research Site, Oaxaca, , Mexico
Research Site, San Luis Potosí, , Mexico
Research Site, Amsterdam, , Netherlands
Research Site, Groningen, , Netherlands
Research Site, Leiden, , Netherlands
Research Site, Nijmegen, , Netherlands
Research Site, Bystra, , Poland
Research Site, Gdańsk, , Poland
Research Site, Olsztyn, , Poland
Research Site, Przemysl, , Poland
Research Site, Warszawa, , Poland
Research Site, L'Hospitalet de Llobregat, , Spain
Research Site, Madrid, , Spain
Research Site, Malaga, , Spain
Research Site, Valencia, , Spain
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Edirne, , Turkey
Research Site, Izmir, , Turkey
Research Site, Kadıkoy/Istanbul, , Turkey
Research Site, Çankaya, , Turkey