A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

308

Participants

Timeline

Start Date

October 13, 2020

Primary Completion Date

May 3, 2023

Study Completion Date

January 31, 2026

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Amivantamab

Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is \>=80 kilogram \[kg\]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 and will continue the same treatment in OLE phase then in LTE phase.

DRUG

Pemetrexed

Pemetrexed will be administered as 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm A and will continue the same treatment in OLE phase then in LTE phase.

DRUG

Carboplatin

Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.

DRUG

Pemetrexed

Pemetrexed will be administered as 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm B and will continue the same treatment in OLE phase then in LTE phase.

Trial Locations (229)

402

Chung Shan Medical University Hospital, Taichung

807

Kaohsiung Medical University Chung Ho Memorial Hospital, Kaohsiung City

833

Chang Gung Medical Foundation, Kaohsiung City

2045

Tudogyogyintezet Torokbalint, Törökbálint

2050

Chris O'Brien Lifehouse, Camperdown

2217

St George Hospital, Kogarah

3000

UZ Leuven, Leuven

3144

Cabrini Medical Centre, Malvern

3233

Mátrai Gyógyintézet-Bronchológia, Gyöngyös

5530

CHU UCL Namur - Site Godinne, Yvoir

6009

Sir Charles Gairdner Hospital, Nedlands

6560

Gazi University Hospital, Ankara

6800

Ankara Bilkent City Hospital, Ankara

8000

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz, Székesfehérvár

8800

Algemeen Ziekenhuis Delta, Roeselare

9700

Markusovszky Egyetemi Oktatokorhaz, Szombathely

10002

National Taiwan University Hospital, Taipei

10016

Langone Health at NYC University, NYU School of Medicine, New York

10032

Columbia University Medical Center, New York

10400

Phramongkutklao Hospital and Medical College, Bangkok

10408

National Cancer Center, Gyeonggi-do

10700

Siriraj Hospital, Bangkok

10990

Hospital Pulau Pinang, George Town

13125

Evangelische Lungenklinik Berlin, Berlin

13620

Seoul National University Bundang Hospital, Seongnam-si

14050

Médica Sur, Mexico City

14080

Instituto Nacional de Cancerologia, Mexico City

15006

Hosp Univ A Coruna, A Coruña

20007

Georgetown University Hospital, Washington D.C.

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

21000

Centre Georges Francois Leclerc, Dijon

22030

Trakya University Medical Faculty, Edirne

22031

Virginia Cancer Specialists, Fairfax

23561

Taipei Medical University Shuang Ho Hospital, New Taipei City

24153

Blue Ridge Cancer Care, Salem

26121

Pius-Hospital Oldenburg, Oldenburg

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

28222

Hosp. Univ. Pta. de Hierro Majadahonda, Majadahonda

29010

Hosp Virgen de La Victoria, Málaga

30607

University Cancer And Blood Center LLC, Athens

31008

Clinica Univ. de Navarra, Pamplona

31217

Centro Oncologico de Chihuahua, Chihuahua City

33000

Institut Bergonie, Bordeaux

33604

CHU Bordeaux, Pessac

33612

H. Lee Moffitt Cancer & Research Institute, Tampa

34098

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

34214

Medipol Mega University Hospital, Istanbul

34722

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul

35580

Izmir Medical Park Hospital, Izmir

40138

A O U Sant Orsola Malpighi, Bologna

40447

China Medical University Hospital, Taichung

41013

Hosp. Virgen Del Rocio, Seville

44093

CHU Nantes - Hopital Nord Laënnec, Nantes

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

44281

Meir Medical Center, Kfar Saba

45659

Oncologianova GmbH, Recklinghausen

47014

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

47441

Bethanien Krankenhaus, Moers

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

50586

Hospital Kuala Lumpur, Kuala Lumpur

50937

Universitaetsklinikum Koeln, Cologne

51109

Kliniken der Stadt Koeln gGmbH, Cologne

52727

GyeongSang National University Hospital, Gyeongsangnam-do

53100

Oncologia Integral Satelite, Naucalpan

57104

Sanford Health, Sioux Falls

58128

Chonnam National University Hwasun Hospital, Jeollanam-do

59037

CHR Hôpital Calmette, Lille

59100

University Malaya Medical Centre, Kuala Lumpur

63110

Washington University Medical Center, St Louis

64710

i Can Oncology Center, Monterrey

69126

Thoraxklinik am Universitatsklinikum Heidelberg, Heidelberg

69500

Hospices Civils de Lyon HCL, Bron

72037

Centre Hospitalier Le Mans, Le Mans

74072

Onkologische Schwerpunktpraxis, Heilbronn

75005

Institut Curie, Paris

75702

Texas Oncology Pa, Tyler

81100

Hospital Sultan Ismail, Johor Bahru

82131

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

84106

Utah Cancer Specialists, Salt Lake City

90110

Songklanagarind Hospital, Prince of Songkla University, Songkhla

90404

UCLA, Santa Monica

91010

City of Hope, Duarte

91031

Shaare Zedek Medical Center, Jerusalem

92868

University of California Irvine, Orange

94163

HIA Begin, Saint-Mandé

95123

Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico, Catania

97213

Providence Portland Medical Center, Portland

99437

Zentralklinik Bad Berka GmbH, Bad Berka

100142

Beijing Cancer Hospital, Beijing

100853

Chinese PLA General Hospital, Beijing

101199

Beijing Chest hospital, Capital medical university, Beijing

102206

Peking University International Hospital, Beijing

110004

Shengjing Hospital Of China Medical University, Shenyang

110085

Rajiv Gandhi Cancer Institute & Research Centre, New Delhi

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

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

196006

Oncology Medical Clinics AV Medical group, Saint Petersburg

197758

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

200030

Shanghai Chest Hospital, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

200123

Shanghai East Hospital, Shanghai

200433

Shanghai Pulmonary Hospital, Shanghai

210031

Nanjing Drum Tower Hospital, Nanjing

213003

The First People's Hospital Of Changzhou, Changzhou

214122

Hospital of Jiangnan University, Wuxi

261000

Weifang People's Hospital, Weifang

264000

Yantai Yuhuangding Hospital, Yantai

300052

Tianjin Medical University General Hospital, Tianjin

310003

The First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou

310009

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

350001

Fujian Medical University Union Hospital, Fuzhou

360000

City Clinical Hospital #1, Nal'chik

400012

Tata Memorial Hospital, Mumbai

400030

Chongqing University Cancer 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

518116

Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen

603000

Nizhny Novgorod Regional Oncological Dispensary, Nizhny Novgorod

610041

West China Hospital Sichuan University, Chengdu

634050

Tomsk Cancer Research Institute, Tomsk

660133

Krasnoyarsk Regional Oncology Dispensary, Krasnoyarsk

664035

Irkutsk Regional Oncology Dispensary, Irkutsk

700160

Tata Medical Center, Kolkata

710061

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

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

9112001

Hadassah Medical Center, Jerusalem

08816

Regional Cancer Care Associates LLC, East Brunswick

14784-400

Fundacao Pio XII, Barretos

30110-017

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

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H4A 3J1

McGill University Health Centre, Montreal

H-1529

Orszagos Koranyi Tbc es Pulmonologiai Intezet, Budapest

00168

Irccs Gemelli, Roma

113 8431

Juntendo University Hospital, Bunkyō City

350-1298

Saitama Medical University International Medical Center, Hidaka

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

596-8501

Kishiwada City Hospital, Kishiwada

650-0047

Kobe City Medical Center General Hospital, Kobe

710-8602

Kurashiki Central Hospital, Kurashiki

830-0011

Kurume University Hospital, Kurume

515-8544

Matsusaka Municipal Hospital, Matsusaka

460-0001

National Hospital Organization Nagoya Medical Center, Nagoya

464 8681

Aichi Cancer Center Hospital, Nagoya

951-8566

Niigata Cancer Center Hospital, Niigata

589 8511

Kindai University Hospital, Osaka Sayama Shi

252-0375

Kitasato University Hospital, Sagamihara

060-8648

Hokkaido University Hospital, Sapporo

028-3695

Iwate Medical University Hospital, Shiwa-gun

411 8777

Shizuoka Cancer Center, Shizuoka

135 8550

The Cancer Institute Hospital of JFCR, Tokyo

791-0295

Ehime University Hospital, Toon-shi

641 8510

Wakayama Medical University Hospital, Wakayama

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

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

1998-018

Hosp. Cuf Descobertas, Lisbon

G1R 2J6

Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos, Lisbon

4099-001

Centro Hospitalar Universitario do Porto, EPE, Porto

4200-072

Instituto Portugues de Oncologia, Porto

4434 502

Centro Hospitalar de Vila Nova de Gaia Espinho E P E, Vila Nova de Gaia

00935

Pan American Center for Oncology Trials LLC, Rio Piedras

02841

Korea University Anam Hospital, Seoul

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

SW3 6JJ

The Royal Marsden NHS Trust, London

SM2 5PT

The Royal Marsden NHS Trust, Sutton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT04538664 - A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions | Biotech Hunter | Biotech Hunter