A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,074

Participants

Timeline

Start Date

September 30, 2020

Primary Completion Date

August 11, 2023

Study Completion Date

June 29, 2027

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Amivantamab

Participants will receive amivantamab intravenously.

DRUG

Osimertinib

Participants will receive osimertinib capsules orally.

DRUG

Lazertinib

Participants will receive lazertinib tablets orally.

DRUG

Placebo

Participants will receive matching placebo orally.

Trial Locations (267)

402

Chung Shan Medical University Hospital, Taichung

704

National Cheng Kung University Hospital, Tainan City

807

Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City

824

E-DA Hospital, Kaohsiung City

833

Chang Gung Medical Foundation, Kaohsiung City

1200

Cliniques Universitaires Saint Luc, Brussels

1340

Clinique Saint Pierre, Ottignies

2045

Tudogyogyintezet Torokbalint, Törökbálint

2145

Westmead Hospital, Westmead

2500

Southern Medical Day Care Centre, Wollongong

3000

UZ Leuven, Leuven

3084

Austin Hospital, Heidelberg

3144

Cabrini Medical Centre, Malvern

3233

Mátrai Gyógyintézet-Bronchológia, Gyöngyös

4102

Princess Alexandra Hospital, Woolloongabba

5042

Flinders Medical Centre, Bedford Park

6009

Sir Charles Gairdner Hospital, Nedlands

6060

Grand Hopital De Charleroi Site Les Viviers, Charleroi

6150

St John of God Hospital Murdoch, Murdoch

6560

Gazi University Hospital, Ankara

6800

Ankara Bilkent City Hospital, Ankara

8000

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz, Székesfehérvár

8308

Korea University Guro Hospital, Seoul

8582

Veszprém Megyei Tudőgyógyintézet, Farkasgyepü

8800

Algemeen Ziekenhuis Delta, Roeselare

9700

Markusovszky Egyetemi Oktatokorhaz, Szombathely

10002

National Taiwan University Hospital, Taipei

10043

Aou San Luigi Gonzaga, Orbassano

10400

Phramongkutklao Hospital and Medical College, Bangkok

10700

Siriraj Hospital, Bangkok

10990

Hospital Pulau Pinang, George Town

13620

Seoul National University Bundang Hospital, Seongnam-si

13915

Hopital Nord, Marseille

14050

Médica Sur, Mexico City

14080

Instituto Nacional de Cancerologia, México

14165

Helios Klinikum Emil von Behring GmbH, Berlin

15006

Hosp Univ A Coruna, A Coruña

15232

University of Pittsburgh Medical Center, Pittsburgh

17007

Institut Català D'Oncologia Girona, Girona

20052

San Gerardo Hospital, Monza

20089

Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20132

IRCCS Ospedale San Raffaele, Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia, Milan

21044

Maryland Oncology Hematology, PA, Columbia

22030

Trakya University Medical Faculty, Edirne

22031

Virginia Cancer Specialists, Fairfax

23561

Taipei Medical University Shuang Ho Hospital, New Taipei City

25100

Hospital Tengku Ampuan Afzan, Kuantan

26121

Pius-Hospital Oldenburg, Oldenburg

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

28222

Hosp. Univ. Pta. de Hierro Majadahonda, Majadahonda

28644

Chungbuk National University Hospital, Cheongju-si

29011

Hosp Regional Univ de Malaga, Málaga

30607

University Cancer And Blood Center LLC, Athens

31008

Clinica Univ. de Navarra, Pamplona

32256

Cancer Specialists of North Florida, Jacksonville

33000

Institut Bergonie, Bordeaux

33604

CHU Bordeaux, Pessac

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd, Istanbul

34214

Medipol Mega University Hospital, Istanbul

34722

T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi, Istanbul

35575

Medical Point, Izmir

37000

CHU Bretonneau, Tours

CIMOVA, Morals Vargas Centro de Investigación SC, León

37203

Sarah Cannon Research Institute, Nashville

38700

CHU de Grenoble Hopital Albert Michallon, La Tronche

40447

China Medical University Hospital, Taichung

41013

Hosp. Virgen Del Rocio, Seville

42080

Necmettin Erbakan University Meram Medical Faculty, Konya

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

44281

Meir Medical Center, Kfar Saba

44800

CHU Nantes, Sain-Herblain

45147

Universitaetsklinikum Essen, Essen

46014

Hosp. Gral. Univ. Valencia, Valencia

46050

Beacon Hospital Sdn Bhd, Petaling Jaya

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48108

Inje University Haeundae Paik Hospital, Busan

48121

Ospedale S. Maria Delle Croci, Ravenna

48202

Henry Ford Hospital, Detroit

49100

Rabin Medical Center, Petah Tikva

49102

Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4, Dnipro

50009

Hosp. Clinico Univ. Lozano Blesa, Zaragoza

50200

Chiang Mai University, Chiang Mai

50586

Hospital Kuala Lumpur, Kuala Lumpur

51109

Kliniken der Stadt Koeln gGmbH, Cologne

53100

Oncologia Integral Satelite, Naucalpan

55435

Minnesota Oncology Hematology P A, Edina

55905

Mayo Clinic, Rochester

59000

Institute Coeur Poumon, Lille

59100

University Malaya Medical Centre, Kuala Lumpur

61070

Municipal non-profit enterprise 'Regional Center of Oncology', Kharkiv

63110

Washington University School Of Medicine, St Louis

64710

i Can Oncology Center, Monterrey

69126

Thoraxklinik am Universitatsklinikum Heidelberg, Heidelberg

69500

Hospices Civils de Lyon HCL, Bron

70006

East Jefferson General Hospital, Metairie

70376

Robert-Bosch-Krankenhaus - Klinik Schillerhoehe, Stuttgart

74072

Onkologische Schwerpunktpraxis, Heilbronn

75005

Institut Curie, Paris

75970

Hopital Tenon, Paris

77030

Oncology Consultants Texas, Houston

78745

Texas Oncology P A, Austin

80100

Ospedale Monaldi, Napoli

80124

Rocky Mountain Cancer Centers, Lone Tree

81100

Hospital Sultan Ismail, Johor Bahru

82131

Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting, Gauting

83100

Ospedale San Giuseppe Moscati di Avellino, Avellino

85364

Yuma Regional Medical Center, Yuma

85395

Arizona Oncology Associates, PC - HAL, Goodyear

87000

CHU de Limoges, Limoges

88000

Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal, Uzhhorod

90110

Songklanagarind Hospital, Prince of Songkla University, Songkhla

90813

City of Hope Long Beach Elm, Long Beach

92868

University of California Irvine, Orange

94163

HIA Begin, Saint-Mandé

94805

Institut Gustave Roussy, Villejuif

95123

Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico, Catania

97401

Willamette Valley Cancer Institute and Research Center, Eugene

99437

Zentralklinik Bad Berka GmbH, Bad Berka

100050

Beijing Friendship Hospital Capital Medical University, Beijing

100142

Beijing Cancer Hospital, Beijing

100853

Chinese PLA General Hospital, Beijing

101199

Beijing Chest hospital, Capital medical university, Beijing

110022

Shengjing Hospital Of China Medical University, Shenyang

115533

MCK, Moscow

130000

Jilin cancer hospital, Changchun

143423

Moscow City Oncology Hospital № 62, Krasnogorsk

150000

Harbin medical university cancer hospital, Harbin

150054

Yaroslavl Regional Clinical Oncology Hospital, Yaroslavl

188663

Leningrad Regional Oncology Dispensary, Kuzmolovsky

190121

Current medical technologies, Saint Petersburg

196006

Oncology Medical Clinics AV Medical group, Saint Petersburg

197758

N.N. Petrov Research Institute Of Oncology, Saint Petersburg

200025

Ruijin Hospital Shanghai Jiao Tong University, Shanghai

200030

Shanghai Chest Hospital, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

200123

Shanghai East Hospital, Shanghai

213003

The First People's Hospital Of Changzhou, Changzhou

226300

Nantong Tumor Hospital, Nantong

264000

Yantai Yuhuangding Hospital, Yantai

300052

Tianjin Medical University General Hospital, Tianjin

310009

Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou

The Second Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou

310016

Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

317000

Taizhou Hospital of Zhejiang Province, Linhai

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

360000

City Clinical Hospital #1, Nal'chik

392013

Tambov Regional Oncology Clinical Dispansary, Tambov

400012

Tata Memorial Hospital, Mumbai

400038

Southwest Hospital, Chongqing

410013

Hunan Cancer hospital, Changsha

411013

Noble Hospital Pvt Ltd, Pune

422002

HCG Manavta Cancer Centre, Nashik

430030

TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

450083

Bashkir State Medical University, Ufa

500034

Basavatarakam Indo-American Hospital, Hyderabad

510080

The First Affiliated Hospital Sun Yat sen University, Guangzhou

510120

Sun Yat-Sen Memorial Hospital Sun Yat-sen University, Guangzhou

516001

Huizhou Municipal Central Hospital, Huizhou

603000

Nizhny Novgorod Regional Oncological Dispensary, Nizhny Novgorod

610041

Sichuan Cancer Hospital, Chengdu

West China Hospital Sichuan University, Chengdu

634050

Tomsk Cancer Research Institute, Tomsk

660133

Krasnoyarsk Regional Oncology Dispensary, Krasnoyarsk

664013

Omsk Clinical Oncology Dispensary, Omsk

664035

Irkutsk Regional Oncology Dispensary, Irkutsk

700160

Tata Medical Center, Kolkata

710061

The First Affiliated Hospital of Xian Jiaotong University, Xi'an

830000

Cancer Hospital of Xinjiang Medical University, Ürümqi

3109601

Rambam Health Corporation, Haifa

5262100

Chaim Sheba Medical Center, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

9112001

Hadassah Medical Center, Jerusalem

08816

Astera Cancer Care, East Brunswick

C1426AGE

Centro Oncológico Korben, Buenos Aires

C1428ANZ

Instituto Alexander Fleming, Buenos Aires

X5016KEH

Hospital Privado Centro Medico de Cordoba, Córdoba

F5300COE

Centro Oncologico Riojano Integral (Cori), La Rioja

R8500ACE

Clínica Viedma, Viedma

14784-400

Fundacao Pio XII, Barretos

30110-022

Cetus Oncologia, Belo Horizonte

88020-210

Ynova Pesquisa Clinica, Florianópolis

98700-000

Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda, Ijuí

59062 000

Liga Norte Riograndense Contra O Cancer, Natal

96020 080

UPCO Unidade de Pesquisa Clinica em Oncologia, Pelotas

90020-090

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre

20231 050

Ministerio da Saude Instituto Nacional do Cancer, Rio de Janeiro

22 250 905

Oncoclinicas Rio de Janeiro S A, Rio de Janeiro

22281 100

Instituto D Or de Pesquisa e Ensino IDOR, Rio de Janeiro

01246 000

Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo, São Paulo

01509 900

Fundacao Antonio Prudente A C Camargo Cancer Center, São Paulo

04014-002

Núcleo de Pesquisa São Camilo, São Paulo

18030-075

IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado, Sorocaba

29308-014

Hospital Evangélico de Cachoeiro de Itapemirim, Vitória

L6R 3J7

William Osler Health System, Brampton

L8V 5C2

Juravinski Cancer Centre, Hamilton

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

H4A 3J1

McGill University Health Centre, Montreal

06120

Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH, Halle

04357

POIS Leipzig GbR, Leipzig

H-1529

Orszagos Koranyi Tbc es Pulmonologiai Intezet, Budapest

00168

Irccs Gemelli, Roma

113 8431

Juntendo University Hospital, Bunkyō City

104 0045

National Cancer Center Hospital, Chūōku

810-8563

National Hospital Organization Kyushu Medical Center, Fukuoka

670-8520

National Hospital Organization Himeji Medical Center, Himeji

573 1191

Kansai Medical University Hospital, Hirakata

920 8641

Kanazawa University Hospital, Kanazawa

277 8577

National Cancer Center Hospital East, Kashiwa

830-0011

Kurume University Hospital, Kurume

515-8544

Matsusaka Municipal Hospital, Matsusaka

951-8566

Niigata Cancer Center Hospital, Niigata

700 8558

Okayama University Hospital, Okayama

589 8511

Kindai University Hospital, Osaka Sayama Shi

377-0280

National Hospital Organization Shibukawa Medical Center, Shibukawa

135 8550

The Cancer Institute Hospital of JFCR, Tokyo

152 8902

National Hospital Organization Tokyo Medical Center, Tokyo

791-0295

Ehime University Hospital, Toon-shi

560-8552

National Hospital Organization Osaka Toneyama Medical Center, Toyonaka-shi

641 8510

Wakayama Medical University Hospital, Wakayama

740-8510

National Hospital Organization Iwakuni Clinical Center, Yamaguchi

755-0241

National Hospital Organization Yamaguchi Ube Medical Center, Yamaguchi

03100

Mexico Centre for Clinical Research, S.A. de C.V., Mexico City

Health Pharma Professional Research, México

5223 GZ

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

6815 AD

Rijnstate Ziekenhuis, Arnhem

3844 DG

Ziekenhuis St Jansdal, Harderwijk

6525AG

UMC Radboud, Nijmegen

85 796

Centrum Onkologii im Prof F Lukaszczyka, Bydgoszcz

80 214

Uniwersyteckie Centrum Kliniczne, Gdansk

81 519

Szpitale Pomorskie Sp z o o, Gdynia

10-357

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie, Olsztyn

60-693

Private Specialist Hospitals - MedPolonia, Poznan

02-781

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warsaw

1769-001

Uls Santa Maria - Hosp. Pulido Valente, Lisbon

4099-001

Uls Santo Antonio - Hosp. Santo Antonio, Porto

4100 180

Hosp. Cuf Porto, Porto

4200-072

Instituto Portugues de Oncologia, Porto

00935

Pan American Center for Oncology Trials LLC, Rio Piedras

03181

Kangbuk Samsung Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Mary s Hospital, Seoul

08916

Inst. Cat. D'Oncologia-Badalona, Badalona

08025

Hosp. de La Santa Creu I Sant Pau, Barcelona

08028

Hosp. Univ. Quiron Dexeus, Barcelona

08035

Hosp Univ Vall D Hebron, Barcelona

09003

Hosp. Univ. de Burgos, Burgos

01060

Adana City Hospital, Adana

01250

Başkent University Medical Faculty Adana Application and Research Center, Adana

02091

Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies', Kyiv

03022

National Cancer Institute, Kyiv

EH4 2XU

Edinburgh Cancer Centre Western General, Edinburgh

NW1 2PG

UCL Cancer Institute, London

SW10 9NH

Chelsea And Westminster Hospital, London

SW3 6JJ

The Royal Marsden NHS Trust, London

M20 4BX

Christie NHS Foundation Trust, Manchester

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

SM2 5PT

The Royal Marsden NHS Trust, Sutton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY