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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
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: 61186372NSC3001: 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
2027-12-31
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Carboplatin
Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.
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 (232)
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 Chest Tumor Internal Medicine dept. II
Beijing, China
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 Chest Tumor Internal Medicine dept. II
Changsha, 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 1
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