Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

PHASE3RecruitingINTERVENTIONAL
Enrollment

740

Participants

Timeline

Start Date

March 4, 2022

Primary Completion Date

February 29, 2028

Study Completion Date

April 30, 2028

Conditions
Metastatic Non Small Cell Lung Cancer
Interventions
DRUG

Datopotamab Deruxtecan

Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

DRUG

Pembrolizumab

Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Trial Locations (242)

100

RECRUITING

National Taiwan University Hospital, Taipei

112

RECRUITING

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

133

RECRUITING

Policlinico Tor Vergata, Rome

144

RECRUITING

Ifo Regina Elena, Rome

333

RECRUITING

Chang Gung Memorial Hospital LinKou, Taoyuan District

704

RECRUITING

National Cheng Kung University Hospital Nckuh, Tainan City

824

RECRUITING

E-Da Hospital, Kaohsiung City

833

RECRUITING

Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch, Kaohsiung City

1083

RECRUITING

Semmelweis University Department of Pulmonology, Budapest

1090

RECRUITING

Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf, Vienna

1125

RECRUITING

Fundacion CENIT para la investigación en Neurociencias, Ciudad Autonoma de Buenos Aire

1130

RECRUITING

Adana Acibadem Hospital, Adana

1140

RECRUITING

Medical Park Seyhan Hospital, Seyhan /Adana

2045

RECRUITING

Pulmonology Hospital Torokbalint, Törökbálint

2050

RECRUITING

Chris Obrien Lifehouse, Camperdown

2700

RECRUITING

Centro de Investigación Pergamino S. A., Pergamino

3084

RECRUITING

Austin Hospital, Heidelberg

3149

RECRUITING

Peninsula and South Eastern Haematology and Oncology Group, Mount Waverley

4031

RECRUITING

University Hospital Basel, Basel

5011

RECRUITING

The Queen Elizabeth Hospital, Woodville South

5400

RECRUITING

CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica, San Juan

5404

RECRUITING

Kantonsspital Baden, Baden

5505

RECRUITING

Asan Medical Center, Songpa-gu

6000

RECRUITING

Grand Hopital de Charleroi - Hopital Saint Joseph, Charleroi

RECRUITING

Bkmk Hospital, KecskemĂŠt

6351

RECRUITING

Samsung Medical Center, Seoul

6591

RECRUITING

The Catholic Univ. of Korea, Seoul St. Mary'S Hospital, Seoul

7070

RECRUITING

Akdeniz University Hospital, Antalya

8000

RECRUITING

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8035

RECRUITING

Hospital Universitari Vall D'Hebron, Barcelona

8500

RECRUITING

Clinica Viedma SA, Viedma

8582

RECRUITING

Veszprem Megyei Tudogyogyintezet Farkasgyepu, Farkasgyepű

9000

RECRUITING

Az Maria Middelares - Campus Maria Middelares, Ghent

9100

RECRUITING

AZ Nikolaas, Sint-Niklaas

9300

RECRUITING

Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst, Aalst

10050

RECRUITING

Inner Mongolia Medical University- the Affiliated Hospital, Hohhot

10330

RECRUITING

Faculty of Medicine Chulalongkorn University, Bangkok

10408

RECRUITING

National Cancer Center, Goyang-si

10461

RECRUITING

Montefiore Medical Center, The Bronx

10700

RECRUITING

Siriraj Hospital, Bangkok

11217

RECRUITING

Taipei Veterans General Hospital, Taipei

11527

RECRUITING

Sotiria General Hosptial of Chest Diseases, Athens

13015

RECRUITING

APHM - Hopital Nord, Marseille

13125

TERMINATED

Evangelische Lungenklinik Berlin, Berlin

13273

RECRUITING

Institut Paoli-Calmettes, Marseille

13620

RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

14564

RECRUITING

Metropolitan Hospital, Neo Faliro

18547

RECRUITING

Metropolitan Hospital, Neo Faliro

RECRUITING

Metropolitan Hospital, Piraeus

20132

RECRUITING

IRCCS Ospedale San Raffaele, Milan

20141

RECRUITING

Irccs Istituto Europeo Di Oncologia, Milan

20817

RECRUITING

American Oncology Partners of Maryland, Bethesda

21100

RECRUITING

Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi, Varese

21205

RECRUITING

Johns Hopkins University, Baltimore

22927

RECRUITING

LungenClinic Grosshansdorf, Großhansdorf

25198

RECRUITING

Hospital Universitario Arnau de Vilanova - Lleida, Lleida

28007

RECRUITING

Hospital General Universitario Gregorio Marañon, Madrid

28040

RECRUITING

Hospital Clinico San Carlos, Madrid

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28644

RECRUITING

Chungbuk National University Hospital, Cheongju-si

29010

RECRUITING

Hospital Regional Universitario Malaga, Málaga

32005

RECRUITING

CHUO, Ourense

33075

RECRUITING

Bordeaux University Hospital - Hopital Saint Andre, Bordeaux

33076

RECRUITING

Institut Bergonie, Bordeaux

34295

RECRUITING

Centre Hospitalier Universitaire de Montpellier, Montpellier

34772

RECRUITING

Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul

35100

RECRUITING

Ege University, Bornova-İzmir

40002

RECRUITING

Srinagarind Hospital, Muaeng

40201

RECRUITING

Chung Shan Medical University Hospital, Taichung

40705

RECRUITING

Taichung Veterans General Hospital, Taichung

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

41014

RECRUITING

Hospital Universitario de Valme, Seville

42119

RECRUITING

Kyungpook National University Chilgok Hospital, Daegu

44093

RECRUITING

CHU de Nantes, Nantes

44277

RECRUITING

Hopital prive du Confluent, Nantes

44280

RECRUITING

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

45500

RECRUITING

University Hospital of Ioannina Uhi, Ioannina

46026

RECRUITING

Hospital Universitari i Politècnic La Fe, Valencia

50009

RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

52727

RECRUITING

Gyeongsang National University Hospital, Jinju

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

54622

RECRUITING

Bioclinic Thessaloniki, Thessaloniki

55100

RECRUITING

Ospedale San Luca, Lucca

55236

RECRUITING

St. Luke's Hospital, Thessaloniki

59000

RECRUITING

Centre Hospitalier Universitaire de Lille, Lille

64460

RECRUITING

Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey

66100

RECRUITING

UOC Oncologia, Chieti

68020

RECRUITING

Centro de Investigacion Clinica de Oaxaca (CICLO), Oaxaca City

69008

RECRUITING

Centre Leon Berard, Lyon

70124

RECRUITING

IRCCS Istituto Oncologico Giovanni Paolo II, Bari

73730

RECRUITING

Klinikum Esslingen GmbH, Esslingen am Neckar

75063

RECRUITING

Arizona Oncology NAHOA, Irving

RECRUITING

Cancer Care Center of Brevard, Irving

RECRUITING

Illinois Cancer Specialists, Irving

RECRUITING

Maryland Oncology Hematology, Irving

RECRUITING

Southern Cancer Center, Irving

RECRUITING

Texas Oncology - Northeast Texas, Irving

RECRUITING

Texas Oncology Gulf Coast, Irving

RECRUITING

Texas Oncology McAllen, Irving

WITHDRAWN

Woodlands Medical, Irving

75970

RECRUITING

AP-HP - Hopital Tenon, Paris

78209

RECRUITING

Oncologico Potosino, San Luis Potosí City

78229

RECRUITING

University of Texas Health Science Center San Antonio, San Antonio

80131

RECRUITING

Azienda Ospedaliera dei Colli, Naples

80336

RECRUITING

Klinikum der Universitaet Muenchen, München

80909

RECRUITING

Uch-Mhs D/B/A Memorial Health System, Colorado Springs

84000

RECRUITING

Sainte-Catherine Institut du Cancer Avignon-Provence (ICAP), Avignon

84106

RECRUITING

Utah Cancer Specialists, Salt Lake City

85224

RECRUITING

Ironwood Cancer and Research Center, Chandler

86000

RECRUITING

CHU de Poitier Pole Regional de Cancerologie, Poitiers

90095

RECRUITING

UCLA HemOnc - Clinical Research Unit, Los Angeles

90110

RECRUITING

Prince of Songkla University PSU - Faculty of Medicine, Hat Yai

90602

RECRUITING

PIH Health Whittier Hospital, Whittier

90603

TERMINATED

The Oncology Institute of Hope and Innovation, Whittier

92150

RECRUITING

Hopital FOCH, Suresnes

92501

WITHDRAWN

Compassionate Cancer Care Medical Group, Riverside

93105

RECRUITING

Ridley-Tree Cancer Center, Santa Barbara

94158

WITHDRAWN

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

98108

RECRUITING

VA Puget Sound Health Care System - VAPSHCS, Seattle

98503

RECRUITING

Providence Regional Cancer System, Lacey

99999

RECRUITING

Prince of Wales Hospital / The Chinese University of Hong Kong 99999, Hong Kong

100044

RECRUITING

Peking University Peoples Hospital, Beijing

100142

RECRUITING

Peking University Cancer Hospital, Beijing

110001

RECRUITING

The First Hospital of China Medical University, Shenyang

110801

RECRUITING

Liaoning Cancer Hospital& Institute, Shenyang

130012

RECRUITING

Jilin Cancer Hospital, Changchun

150081

RECRUITING

Harbin Medical University Cancer Hospital, Harbin

154007

RECRUITING

Jiamusi Tumor and Tuberculosis Hospital, Jiamusi

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai Shi

200094

RECRUITING

Onco Clinic Consult SA, Craiova

200433

RECRUITING

Shanghai Pulmonary Hospital, Shanghai

200542

RECRUITING

Centrul de Oncologie Sf Nectarie S.R.L., Craiova

210029

TERMINATED

Jiangsu Province Hospital, Nanjing

276000

RECRUITING

Linyi Cancer Hospital, Linyi

300052

RECRUITING

Tianjin Medical University General Hospital, Tianjin

300166

RECRUITING

Oncocenter-Oncologie Clinica SRL, Timișoara

300239

RECRUITING

SC Oncomed SRL, Timișoara

310003

RECRUITING

The First Affiliated Hospital of College of Medicine Zhejiang University, Hanghzou

310022

WITHDRAWN

Zhejiang Cancer Hospital, Hangzhou

330006

RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

361001

RECRUITING

The First Affiliated Hospital Xiamen University, Xiamen

400042

RECRUITING

Army Medical Center of PLA, Chongqing

410013

RECRUITING

Hunan Cancer Hospital, Changsha

430022

RECRUITING

Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology, Wuhan

430079

RECRUITING

Hubei Cancer Hospital, Wuhan

441000

RECRUITING

Xiangyang Central Hospital- 5 Lumen Avenue, Xiangyang

450008

RECRUITING

Henan Cancer Hospital, Zhengzhou

510095

RECRUITING

Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou

530021

RECRUITING

Guangxi Medical University Affiliated Tumor Hospital, Nanning

570208

RECRUITING

Haikou People's Hospital, Haikou

610001

RECRUITING

Cangzhou People's Hospital, Cangzhou

610049

WITHDRAWN

Sichuan Cancer Hospital, Chengdu

641000

RECRUITING

The Second People's Hospital of Neijiang, Neijiang

650118

TERMINATED

Yunnan Cancer Hospital, Kunming

710061

RECRUITING

The First Affiliate Hospitalof Xi'An Jiaotong University, Xi'an

720214

RECRUITING

Sc Sigmedical Services Srl, Suceava

830000

RECRUITING

Xinjiang Tumor Hospital, Ürümqi

999077

RECRUITING

Queen Mary Hospital, Pok Fu Lam

7500000

RECRUITING

Oncovida, Santiago

7500653

RECRUITING

Centro de Estudios Clínicos SAGA, Santiago

7500921

RECRUITING

Fundación Arturo Pérez López, Santiago

7501010

RECRUITING

Orlandi Oncología, Santiago

02115

RECRUITING

Dana-Farber Cancer Institute, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

WITHDRAWN

DFCI - Steward St. Elizabeth's Medical Center, Boston

02035

TERMINATED

Dana Farber Cancer Institute - Foxborough, Foxborough

01757

WITHDRAWN

Dana Farber Cancer Institute - Milford Medical Center, Milford

02190

TERMINATED

DFCI - South Shore Hospital, South Weymouth

03766

RECRUITING

Dartmouth Hitchcock Medical Center, Lebanon

08816

RECRUITING

Astera Cancer Care, East Brunswick

07728

RECRUITING

Regional Cancer Care Associates LLC, Freehold

08901

RECRUITING

Cooperman Barnabas Medical Center, New Brunswick

07652

RECRUITING

The Valley Hospital, Paramus

B7602CBM

RECRUITING

Hospital Privado de la Comunidad, Mar del Plata

S2000

RECRUITING

Instituto de Oncología de Rosario, Rosario

S2001

RECRUITING

Sanatorio Parque, Rosario

S2002

RECRUITING

Sanatorio Británico de Rosario, Rosario

Unknown

RECRUITING

Klinikum Klagenfurt am Wörthersee Abteilung für Lungenkrankheiten, Klagenfurt

RECRUITING

Instituto do Cancer Brasil - Unidade Taubate, Taubaté

RECRUITING

Queen Elizabeth Hospital, Hong Kong

RECRUITING

Yamanashi Prefectural Central Hospital, Kofu

RECRUITING

Kantonsspital St. Gallen, Sankt Gallen

95020-972

RECRUITING

Instituto de Pesquisas em Saúde - IPS, Caxias do Sul

81520-060

RECRUITING

Hospital Erasto Gaertner, Curitiba

98700-000

RECRUITING

Oncosite - Centro de Pesquisa Clinica Oncologia, Ijuí

88301-220

RECRUITING

Clínica de Neoplasias Litoral, Itajaí

96020-080

RECRUITING

UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks, Pelotas

90050-170

RECRUITING

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

20231-050

RECRUITING

Instituto Nacional de Câncer - INCA, Rio de Janeiro

09060-870

RECRUITING

Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO, Santo André

01236-030

RECRUITING

Instituto de Ensino e Pesquisas Sao Lucas, São Paulo

H1T 2M4

WITHDRAWN

Santa Cabrini Hospital, Montreal

H4A 3J2

RECRUITING

McGill University Health Centre, Montreal

254-0488

RECRUITING

Centro de Investigaciones Clinicas Vina Del Mar, Viña del Mar

06132

RECRUITING

A.O. Perugia Santa Maria della Misericordia, Perugia

030-8553

RECRUITING

Aomori Prefectural Central Hospital, Aomori

277-8577

RECRUITING

National Cancer Center Hospital East, Kashiwa-shi

791-0280

RECRUITING

NHO Shikoku Cancer Center, Matsuyama

811-1395

RECRUITING

National Hospital Organization Kyushu Cancer Center, Fukuoka

812-8582

RECRUITING

Kyushu University Hospital, Fukuoka

830-0011

RECRUITING

Kurume University Hospital, Kurume-shi

920-8641

RECRUITING

Kanazawa University Hospital, Kanazawa

241-8515

RECRUITING

Kanagawa Cancer Center, Yokohama

861- 4193

RECRUITING

Saiseikai Kumamoto Hospital, Kumamoto

515-8544

RECRUITING

Matsusaka Municipal Hospital, Matsusaka-shi

980-0873

RECRUITING

Sendai Kousei Hospital, Sendai

961-8566

RECRUITING

Niigata Cancer Center Hospital, Niigata

573-1191

RECRUITING

Kansai Medical University Hospital, Hirakata-shi

541-8567

RECRUITING

Osaka International Cancer Institute, Osaka

591-8555

RECRUITING

NHO Kinki-Chuo Chest Medical Center, Sakai-shi

362-0806

WITHDRAWN

Saitama Cancer Center, Ina-machi

321-0293

RECRUITING

Dokkyo Medical University Hospital, Shimotsuga-gun

113-8431

RECRUITING

Juntendo University Hospital, Bunkyo-ku

113-8677

RECRUITING

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyō-Ku

135-8550

RECRUITING

The Cancer Institute Hospital of JFCR, Kōtoku

143-8541

RECRUITING

Toho University Omori Medical Center, Ōta-ku

740-8510

RECRUITING

NHO Iwakuni Clinical Center, Iwakuni-shi

755-0241

RECRUITING

Yamaguchi-Ube Medical Center, Ube-shi

602-8566

RECRUITING

University Hospital Kyoto Prefectural University of Medicine, Kyoto

560-8552

RECRUITING

Osaka Toneyama Medical Center, Osaka

006-8555

RECRUITING

Teine Keijinkai Hospital, Sapporo

06100

RECRUITING

Cryptex Investigacion Clinica Sa de Cv, Cuauhtémoc

6815 AD

RECRUITING

Rijnstate Ziekenhuis, Arnhem

5223 GZ

RECRUITING

Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital, 's-Hertogenbosch

1081 HZ

RECRUITING

Amsterdam Umc, Location Vumc, Amsterdam

2333 ZA

RECRUITING

Leiden University Medical Center, Leiden

93-338

RECRUITING

Instytut Centrum Zdrowia Matki Polki, Lodz

81-519

RECRUITING

Szpitale Pomorskie Sp. z o.o., Gdynia

70-784

RECRUITING

Dom Lekarski SA, Szczecin

15-450

RECRUITING

II Klinika Chorob Pluc I Gruzlicy, Bialystok

20-064

RECRUITING

MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna, Lublin

1400-038

RECRUITING

Centro Clinico Champalimau, Lisbon

4099-001

RECRUITING

Centro Hospitalar e Universitário do Porto, Porto

4100-180

RECRUITING

Hospital CUF Porto, Porto

4200-072

RECRUITING

Instituto Portuguas de Oncologia do Porto Francisco Gentil, Porto

4200-319

RECRUITING

Centro Hospitalar Universitário de São João, Porto

08036

RECRUITING

Hospital Clinic i Provincial de Barcelona, Barcelona

A4410

RECRUITING

Kantonsspital Baselland, Liestal

06520

RECRUITING

Memorial Ankara Hospital Ankara, Çankaya

B9 5SS

RECRUITING

Birmingham Heartlands Hospital, Birmingham

G12 0YN

WITHDRAWN

Beatson West of Scotland Cancer Centre, Glasgow

NG5 1PB

RECRUITING

Nottingham University Hospitals, Nottingham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY