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ACTIVE NOT RECRUITING
NCT04538664
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.

Official title: A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

308

Start Date

2020-10-13

Completion Date

2027-08-02

Last Updated

2026-03-19

Healthy Volunteers

No

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.

Locations (229)

City of Hope 2

Duarte, California, United States

University of California Irvine

Orange, California, United States

UCLA

Santa Monica, California, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

H. Lee Moffitt Cancer & Research Institute

Tampa, Florida, United States

University Cancer And Blood Center LLC

Athens, Georgia, United States

Henry Ford Hospital

Detroit, Michigan, United States

Washington University Medical Center

St Louis, Missouri, United States

Regional Cancer Care Associates LLC

East Brunswick, New Jersey, United States

Langone Health at NYC University, NYU School of Medicine

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

Sanford Health

Sioux Falls, South Dakota, United States

Texas Oncology Pa

Tyler, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Blue Ridge Cancer Care

Salem, Virginia, United States

Chris O'Brien Lifehouse

Camperdown, Australia

St George Hospital

Kogarah, Australia

Cabrini Medical Centre

Malvern, Australia

Sir Charles Gairdner Hospital

Nedlands, Australia

UZ Leuven

Leuven, Belgium

Algemeen Ziekenhuis Delta

Roeselare, Belgium

CHU UCL Namur - Site Godinne

Yvoir, Belgium

Fundacao Pio XII

Barretos, Brazil

Cetus Oncologia

Belo Horizonte, Brazil

Ynova Pesquisa Clinica

Florianópolis, Brazil

Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

Ijuí, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

UPCO Unidade de Pesquisa Clinica em Oncologia

Pelotas, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, Brazil

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Núcleo de Pesquisa São Camilo

São Paulo, Brazil

IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

Sorocaba, Brazil

Hospital Evangélico de Cachoeiro de Itapemirim

Vitória, Brazil

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Beijing Cancer Hospital

Beijing, China

Chinese PLA General Hospital

Beijing, China

Beijing Chest hospital, Capital medical university

Beijing, China

Peking University International Hospital

Beijing, China

Jilin cancer hospital

Changchun, China

Hunan Cancer hospital

Changsha, China

The First People's Hospital Of Changzhou

Changzhou, China

West China Hospital Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Fujian Medical University Union Hospital

Fuzhou, China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, China

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, China

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin medical university cancer hospital

Harbin, China

Taizhou Hospital of Zhejiang Province

Linhai, China

Nanjing Drum Tower Hospital

Nanjing, China

Shanghai Chest Hospital

Shanghai, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanghai East Hospital

Shanghai, China

Shanghai Pulmonary Hospital

Shanghai, China

Shengjing Hospital Of China Medical University

Shenyang, China

Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, China

Tianjin Medical University General Hospital

Tianjin, China

Weifang People's Hospital

Weifang, China

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

Wuhan, China

Hospital of Jiangnan University

Wuxi, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Yantai Yuhuangding Hospital

Yantai, China

Henan Cancer Hospital

Zhengzhou, China

Institut Bergonie

Bordeaux, France

Hospices Civils de Lyon HCL

Bron, France

Centre Georges Francois Leclerc

Dijon, France

Centre Hospitalier Le Mans

Le Mans, France

CHR Hôpital Calmette

Lille, France

CHU Nantes - Hopital Nord Laënnec

Nantes, France

Institut Curie

Paris, France

CHU Bordeaux

Pessac, France

HIA Begin

Saint-Mandé, France

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Evangelische Lungenklinik Berlin

Berlin, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Kliniken der Stadt Koeln gGmbH

Cologne, Germany

Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

Gauting, Germany

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, Germany

Onkologische Schwerpunktpraxis

Heilbronn, Germany

Bethanien Krankenhaus

Moers, Germany

Pius-Hospital Oldenburg

Oldenburg, Germany

Oncologianova GmbH

Recklinghausen, Germany

Orszagos Koranyi Tbc es Pulmonologiai Intezet

Budapest, Hungary

Mátrai Gyógyintézet-Bronchológia

Gyöngyös, Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, Hungary

Markusovszky Egyetemi Oktatokorhaz

Szombathely, Hungary

Tudogyogyintezet Torokbalint

Törökbálint, Hungary

Basavatarakam Indo-American Hospital

Hyderabad, India

Tata Medical Center

Kolkata, India

Tata Memorial Hospital

Mumbai, India

HCG Manavta Cancer Centre

Nashik, India

Rajiv Gandhi Cancer Institute & Research Centre

New Delhi, India

Noble Hospital Pvt Ltd

Pune, India

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

A O U Sant Orsola Malpighi

Bologna, Italy

Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

Catania, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

San Gerardo Hospital

Monza, Italy

Ospedale S. Maria Delle Croci

Ravenna, Italy

Irccs Gemelli

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Juntendo University Hospital

Bunkyō City, Japan

Saitama Medical University International Medical Center

Hidaka, Japan

National Hospital Organization Himeji Medical Center

Himeji, Japan

Kansai Medical University Hospital

Hirakata, Japan

Kanazawa University Hospital

Kanazawa, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Kishiwada City Hospital

Kishiwada, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

Kurashiki Central Hospital

Kurashiki, Japan

Kurume University Hospital

Kurume, Japan

Matsusaka Municipal Hospital

Matsusaka, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Kindai University Hospital

Osaka Sayama Shi, Japan

Kitasato University Hospital

Sagamihara, Japan

Hokkaido University Hospital

Sapporo, Japan

Iwate Medical University Hospital

Shiwa-gun, Japan

Shizuoka Cancer Center

Shizuoka, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Ehime University Hospital

Toon-shi, Japan

Wakayama Medical University Hospital

Wakayama, Japan

National Hospital Organization Yamaguchi Ube Medical Center

Yamaguchi, Japan

Hospital Pulau Pinang

George Town, Malaysia

Hospital Sultan Ismail

Johor Bahru, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Centro Oncologico de Chihuahua

Chihuahua City, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico

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

Mexico City, Mexico

Médica Sur

Mexico City, Mexico

Instituto Nacional de Cancerologia

Mexico City, Mexico

Health Pharma Professional Research

México, Mexico

i Can Oncology Center

Monterrey, Mexico

Oncologia Integral Satelite

Naucalpan, Mexico

Centrum Onkologii im Prof F Lukaszczyka

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Szpitale Pomorskie Sp z o o

Gdynia, Poland

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, Poland

Private Specialist Hospitals - MedPolonia

Poznan, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Hosp. Cuf Descobertas

Lisbon, Portugal

Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

Lisbon, Portugal

Centro Hospitalar Universitario do Porto, EPE

Porto, Portugal

Instituto Portugues de Oncologia

Porto, Portugal

Centro Hospitalar de Vila Nova de Gaia Espinho E P E

Vila Nova de Gaia, Portugal

Pan American Center for Oncology Trials LLC

Rio Piedras, Puerto Rico

Irkutsk Regional Oncology Dispensary

Irkutsk, Russia

Moscow City Oncology Hospital № 62

Krasnogorsk, Russia

Krasnoyarsk Regional Oncology Dispensary

Krasnoyarsk, Russia

Leningrad Regional Oncology Dispensary

Kuzmolovsky, Russia

MCK

Moscow, Russia

City Clinical Hospital #1

Nal'chik, Russia

Nizhny Novgorod Regional Oncological Dispensary

Nizhny Novgorod, Russia

Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

Oncology Medical Clinics AV Medical group

Saint Petersburg, Russia

N.N. Petrov Research Institute Of Oncology

Saint Petersburg, Russia

Tomsk Cancer Research Institute

Tomsk, Russia

Bashkir State Medical University

Ufa, Russia

Yaroslavl Regional Clinical Oncology Hospital

Yaroslavl, Russia

Inje University Haeundae Paik Hospital

Busan, South Korea

National Cancer Center

Gyeonggi-do, South Korea

GyeongSang National University Hospital

Gyeongsangnam-do, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, South Korea

Hosp Univ A Coruna

A Coruña, Spain

Inst. Cat. D'Oncologia-Badalona

Badalona, Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain

Hosp. Univ. Quiron Dexeus

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Univ. de Burgos

Burgos, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, Spain

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Medical Foundation

Kaohsiung City, Taiwan

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Phramongkutklao Hospital and Medical College

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Songklanagarind Hospital, Prince of Songkla University

Songkhla, Thailand

Adana City Hospital

Adana, Turkey (Türkiye)

Başkent University Medical Faculty Adana Application and Research Center

Adana, Turkey (Türkiye)

Gazi University Hospital

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

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

Istanbul, Turkey (Türkiye)

Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, Turkey (Türkiye)

Izmir Medical Park Hospital

Izmir, Turkey (Türkiye)

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

Dnipro, Ukraine

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

Kyiv, Ukraine

National Cancer Institute

Kyiv, Ukraine

Edinburgh Cancer Centre Western General

Edinburgh, United Kingdom

The Royal Marsden NHS Trust

London, United Kingdom

The Royal Marsden NHS Trust

Sutton, United Kingdom