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
NCT ID: NCT05048797
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
454 participants
INTERVENTIONAL
2021-10-28
2027-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Arm 1: Trastuzumab Deruxtecan Arm 2: Standard of Care treatment (platinum, pemetrexed and pembrolizumab)
TREATMENT
NONE
Study Groups
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Arm 1
Trastuzumab Deruxtecan (T-DXd)
Trastuzumab Deruxtecan
Trastuzumab Deruxtecan administered by intravenous infusion
Arm 2
Standard of Care Treatment (platinum, pemetrexed and pembrolizumab)
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease
* Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA
* Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Measurable disease assessed by Investigator based on RECIST 1.1
* Protocol-defined adequate organ function including cardiac, renal, hepatic function
* ECOG 0-1
* Having tumour tissue available for central testing
Exclusion Criteria
* Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases
* Active autoimmune or inflammatory disorders
* Medical history of myocardial infarction within 6 months prior to randomization
* History of non-infectious pneumonitis/ILD, current or suspected ILD
* Lung-specific intercurrent clinical significant severe illness
* Contraindication to platinum-based doublet chemotherapy or pembrolizumab
18 Years
123 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
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)
Countries
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Related Links
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Lung Cancer Study Locator details (for US)
Other Identifiers
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2021-000634-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503674-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D967SC00001
Identifier Type: -
Identifier Source: org_study_id