Lung Cancer Clinical Trial

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

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

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants at least 18 years of age
Locally advanced 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:

Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy)
Any clinically active brain metastases; previously treated brain metastases allowed
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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

264

Study ID:

NCT05048797

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 155 Locations for this study

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Anchorage Alaska, 99508, United States
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Los Angeles California, 90048, United States
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Orange California, 92868, United States
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San Francisco California, 94143, United States
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Santa Monica California, 90404, United States
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Santa Rosa California, 95403, United States
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Silver Spring Maryland, 20910, United States
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Boston Massachusetts, 02118, United States
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Boston Massachusetts, 02215, United States
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Ann Arbor Michigan, 48109, United States
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Basking Ridge New Jersey, 07920, United States
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East Brunswick New Jersey, 08816, United States
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Middletown New Jersey, 07748, United States
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Montvale New Jersey, 07645, United States
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New Brunswick New Jersey, 08901, United States
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Commack New York, 11725, United States
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Harrison New York, 10604, United States
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New York New York, 10065, United States
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Uniondale New York, 11553, United States
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Canton Ohio, 44710, United States
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Columbus Ohio, 43201, United States
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Pittsburgh Pennsylvania, 15232, United States
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Dallas Texas, 75246, United States
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Kennewick Washington, 99336, United States
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Milwaukee Wisconsin, 53226, United States
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Graz , 8036, Austria
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Innsbruck , 6020, Austria
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Linz , 4020, Austria
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Rankweil , 6830, Austria
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Wien , 1210, Austria
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Gent , 9000, Belgium
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Hasselt , 3500, Belgium
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Leuven , 3000, Belgium
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Barretos , 14784, Brazil
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Blumenau , 89010, Brazil
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Brasília , 70200, Brazil
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Florianópolis , 88034, Brazil
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Natal , 59075, Brazil
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Salvador , 40170, Brazil
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Sao Paulo , 01327, Brazil
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São Paulo , 01321, Brazil
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Uberlândia , 38408, Brazil
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Vancouver British Columbia, V5Z 4, Canada
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Brampton Ontario, L6R 3, Canada
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Toronto Ontario, M5G 1, Canada
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Montreal Quebec, H4A 3, Canada
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Beijing , 10014, China
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Beijing , 10073, China
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Changchun , 13002, China
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Changsha , 41000, China
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Changsha , 41001, China
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Chengdu , 61004, China
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Fuzhou , 35001, China
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Guangzhou , 51008, China
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Hangzhou , 31002, China
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Harbin , 15004, China
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Jinan , 25011, China
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Kunming , 65010, China
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Kunming , 65011, China
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Linhai , 31700, China
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Nanchang , 33000, China
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Nanjing , 21002, China
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Shanghai , 20003, China
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Shanghai , 20003, China
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Shanghai , 20003, China
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Shenyang , 11000, China
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Shenyang , 11001, China
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ShenZhen , 51802, China
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Wenzhou , CN-32, China
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Wuhan , 43002, China
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Xi'an , 71006, China
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Xiamen , 36100, China
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Yangzhou , 22500, China
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Zhengzhou City , 45000, China
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Vejle , 7100, Denmark
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Bordeaux , 33000, France
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Dijon , 21079, France
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Le Mans Cedex , 72037, France
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Lyon , 69373, France
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Marseille cedex , 13915, France
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Nantes , 44093, France
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Rennes Cedex 9 , 35033, France
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Toulouse Cedex 9 , 31059, France
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Villejuif Cedex , 94805, France
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Berlin-Zehlendorf , 14165, Germany
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Dresden , 01307, Germany
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Erfurt , 99089, Germany
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Heidelberg , 69126, Germany
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Immenhausen , 34376, Germany
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Köln , 50937, Germany
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Mainz , 55131, Germany
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Mannheim , 68167, Germany
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München , 81377, Germany
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Oldenburg , 26121, Germany
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Ravensburg , 88212, Germany
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Würzburg , 97080, 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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Shatin , 00000, Hong Kong
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Bangalore , 56002, India
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Delhi , 11008, India
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Hyderabad , 50003, India
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Mumbai , 40001, India
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Nashik , 42200, India
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Milan , 20141, Italy
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Monza , 20090, Italy
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Orbassano , 10043, Italy
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Parma , 43100, Italy
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Roma , 00168, Italy
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Verona , 37126, Italy
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Chuo-ku , 104-0, Japan
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Fukuoka-shi , 812-8, Japan
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Kashiwa , 277-8, Japan
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Matsuyama-shi , 791-0, Japan
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Niigata-shi , 951-8, Japan
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Okayama-shi , 700-8, Japan
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Osaka-shi , 541-8, Japan
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Osakasayama-shi , 589-8, Japan
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Sapporo-shi , 060-8, Japan
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Sendai-shi , 980-0, Japan
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Sunto-gun , 411-8, Japan
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Yokohama-shi , 241-8, Japan
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Yonago-shi , 683-8, Japan
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Cheongju-si , 28644, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Gyeonggi-do , 13620, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Cdmx , 03810, Mexico
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Culiacán , 80230, Mexico
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Guadalajara Jalisco , 44280, Mexico
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Merida , 97000, Mexico
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Mexico City , '1408, Mexico
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Oaxaca , 68020, Mexico
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San Luis Potosí , 78200, Mexico
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Amsterdam , 1081 , Netherlands
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Groningen , 9700 , Netherlands
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Leiden , 2333 , Netherlands
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Nijmegen , 6525 , Netherlands
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Gdańsk , 80-21, Poland
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Olsztyn , 10-35, Poland
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Przemysl , 37-70, Poland
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Warszawa , 02-78, Poland
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L'Hospitalet de Llobregat , 08908, Spain
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Madrid , 28041, Spain
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Malaga , 29730, Spain
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Valencia , 46026, Spain
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Kaohsiung , 833, Taiwan
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Taichung , 40201, Taiwan
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Taichung , 40705, Taiwan
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Tainan , 70403, Taiwan
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Taipei , 10048, Taiwan
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Taipei , 235, Taiwan
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Taipei , TAIWA, Taiwan
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Taoyuan , 333, Taiwan
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Edirne , 22030, Turkey
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Izmir , 35040, Turkey
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Kadıkoy/Istanbul , 34722, Turkey
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Çankaya , 06680, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

264

Study ID:

NCT05048797

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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