Lung Cancer Clinical Trial

A Study of Lazertinib and Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

Summary

The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

View Full Description

Full Description

Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer. Amivantamab is a low-fucose, fully human immunoglobulin (IgG)1-based bispecific antibody directed against EGFR and mesenchymal-epithelial transition (MET) tyrosine kinase receptors. Lazertinib is an oral, highly potent, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The study will include screening phase (up to 28 days), a treatment phase (from randomization until the end of treatment visit), and a follow-up phase for both parts (from end of treatment visit until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first). Safety will be assessed by physical examinations, vital signs, electrocardiograms, echocardiograms, ophthalmologic assessments, laboratory tests, adverse event (AE) frequency and severity (by Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) monitoring, and concomitant medication use. The total duration of the study will be up to 1 year and 11 months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started [US]) or an accredited local laboratory (sites outside of the US)
Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease
Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement)

Exclusion Criteria:

Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors
Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
Participant has symptomatic or progressive brain metastases
Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
Participant has uncontrolled tumor-related pain
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

640

Study ID:

NCT05388669

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 195 Locations for this study

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University of California at San Diego
La Jolla California, 92093, United States
City of Hope Long Beach Elm
Long Beach California, 90813, United States
University of California, Irvine
Orange California, 92868, United States
National Jewish Health
Denver Colorado, 80206, United States
Orlando Health
Orlando Florida, 32806, United States
Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
University of Mississippi Medical Center
Jackson Mississippi, 39213, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14203, United States
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York New York, 10016, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires , 1431, Argentina
IADT Instituto Argentino de Diagnostico y Tratamiento
Caba , C1122, Argentina
Centro Oncológico Korben
Ciudad Autonoma de Buenos Aires , C1426, Argentina
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Cordoba , 5000, Argentina
Sanatorio Allende
Cordoba , 5000, Argentina
Clínica Viedma
Viedma , R8500, Argentina
Cancer Research SA
Adelaide , 5000, Australia
Chris O'Brien Lifehouse
Camperdown , 2050, Australia
Peter MacCallum Cancer Centre
Melbourne , 3000, Australia
St John of God Hospital Murdoch
Murdoch , 6150, Australia
Westmead Hospital
Westmead , 2145, Australia
Fundacao Pio Xii - Hospital De Cancer De Barretos
Barretos , 14784, Brazil
Cetus Oncologia
Belo Horizonte , 30110, Brazil
CIONC - Centro Integrado de Oncologia de Curitiba
Curitiba , 80810, Brazil
Ynova Pesquisa Clinica
Florianopolis , 88020, Brazil
Fundação São Francisco Xavier
Ipatinga , 35162, Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas , 96020, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre , 90035, Brazil
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre , 90610, Brazil
Impar Servicos Hospitalares S/A
Rio de Janeiro , 22061, Brazil
Oncoclínicas
Rio De Janeiro , 22250, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Rio de Janeiro , 22281, Brazil
Núcleo de Oncologia da Bahia
Salvador , 40170, Brazil
CEPHO - Faculdade de Medicina do ABC
Santo André , 09060, Brazil
Hospital Nove de Julho
São Paulo , 01409, Brazil
Núcleo de Pesquisa São Camilo
São Paulo , 04014, Brazil
Onco Star SP Oncologia Ltda
São Paulo , 04543, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo , 05652, Brazil
William Osler Health System
Brampton Ontario, L6R 3, Canada
The Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 1, Canada
Beijing Shijitan Hospital, Capital Medical University
Beijing , 10003, China
Beijing Friendship Hospital, Capital Medical University
Beijing , 10005, China
Beijing Cancer Hospital
Beijing , 10014, China
Peking University Third Hospital
Beijing , 10019, China
Beijing Chest hospital, Capital medical university
Beijing , 10114, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing , 20024, China
Jilin cancer hospital
Changchun , 13001, China
The First People's Hospital Of Changzhou
Changzhou , 21300, China
Sichuan Cancer Hospital
Chengdu , 61004, China
West China Hospital, Sichuan University
Chengdu , 61004, China
Chongqing University Cancer Hospital
Chongqing , 40003, China
Southwest Hospital
ChongQing , 40003, China
First Affiliated Hospital of Gannan Medical University
Ganzhou , 34100, China
The First Affiliated Hospital, Sun Yat-sen University
Guang Zhou , 51008, China
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
Guangzhou , 51012, China
Zhejiang Cancer Hospital
Hang Zhou , 31002, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou , 31000, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou , 31001, China
Harbin medical university cancer hospital
Harbin , 15008, China
Huizhou Municipal Central Hospital
Huizhou , 51600, China
Liuzhou people's Hospital
Liuzhou , 54502, China
Fudan University Shanghai Cancer Center
Shanghai , 20003, China
Shenzhen People's Hospital
Shen Zhen Shi , 51800, China
Shengjing Hospital of China Medical University
Shenyang , 11000, China
Shenzhen university General Hospital
Shenzhen , 51805, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan , 43002, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an , 71006, China
Yantai Yuhuangding Hospital
Yantai , 26400, China
Henan Cancer Hospital
Zhengzhou , 45000, China
CHU Grenoble
La Tronche , 38700, France
Institute Coeur Poumon
Lille , 59000, France
CHU de Limoges, Hopital Dupuytren
Limoges , 87000, France
Hopital Nord
Marseille Cedex 20 , 13915, France
Institut Regional du Cancer de Montpellier Val d'Aurelle
Montpellier , 34090, France
CHU Bordeaux
Pessac , 33604, France
Evangelische Lungenklinik Berlin
Berlin , 13125, Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
Georgsmarienhütte , 49124, Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen , 35392, Germany
Munster University Hospital
Münster , 48149, Germany
Oncologianova GmbH
Recklinghausen , 45659, Germany
Onkologische Schwerpunktpraxis
Weinsberg , 74189, Germany
Artemis Hospital
Gurugram , 12200, India
Narayana Superspeciality Hospital, Howrah
Howrah , 71110, India
Somani Hospital
Jaipur , 30201, India
Manipal Comprehensive Cancer Centre, Manipal Hospital
Karnad , 56001, India
Saroj Gupta Cancer Center & Research Institute
Kolkata , 70006, India
Tata Memorial Hospital
Mumbai , 40001, India
HCG Manavta Cancer Centre
Nasik , 42200, India
Sir Ganga Ram Hospital
New delhi , 11006, India
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi , 11008, India
CIMET's Inamdar Multispeciality Hospital
Pune , 41104, India
Rambam Medical Center
Haifa , 31096, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Rabin Medical Center
Petah-Tikva , 49100, Israel
Chaim Sheba Medical Center
Ramat Gan , 52621, Israel
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
Bari , 70124, Italy
A.O.U Sant'Orsola-Malpighi
Bologna , 40138, Italy
European Institute of Oncology
Milano , 20141, Italy
Aou San Luigi Gonzaga
Orbassano , 10043, Italy
Istituto Oncologico Veneto - IRCCS
Padova , 35128, Italy
Ospedale S. Maria Delle Croci
Ravenna , 48121, Italy
A.O. San Camillo Forlanini
Roma , 00152, Italy
Istituto Nazionale Tumori Regina Elena
Rome , 00144, Italy
Istituto Clinico Humanitas
Rozzano , 20089, Italy
National Cancer Center Hospital
Chuo-Ku , 104-0, Japan
National Hospital Organization Himeji Medical Center
Himeji , 670-8, Japan
Kansai Medical University Hospital
Hirakata , 573-1, Japan
Kanagawa Cancer Center
Kanagawa , 241-8, Japan
Kurashiki Central Hospital
Kurashiki , 710-8, Japan
Kurume University Hospital
Kurume , 830-0, Japan
Matsusaka Municipal Hospital
Matsusaka , 515-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Hokkaido University Hospital
Sapporo-shi , 060-8, Japan
Iwate Medical University Hospital
Shiwa-gun , 028-3, Japan
Shizuoka Cancer Center
Shizuoka , 411-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Fujita Health University Hospital
Toyoake , 470-1, Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka-shi , 560-8, Japan
Wakayama Medical University Hospital
Wakayama , 641-8, Japan
National Hospital Organization Iwakuni Clinical Center
Yamaguchi , 740-8, Japan
National Hospital Organization Yamaguchi Ube Medical Center
Yamaguchi , 755-0, Japan
National Cancer Center
Gyeonggi-do , 10408, Korea, Republic of
CHA Bundang Medical Center, CHA University
Gyeonggi-do , 13496, Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do , 13620, Korea, Republic of
GyeongSang National University Hospital
Gyeongsangnam-do , 52727, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Prince Court Medical Centre
Kuala Lumpur , 50450, Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur , 59100, Malaysia
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Hospital Umum Sarawak
Kuching , 93586, Malaysia
Beacon Hospital Sdn. Bhd.
Petaling Jaya , 46050, Malaysia
Sunway Medical Centre
Petaling Jaya , 47500, Malaysia
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz , 85-79, Poland
Krakowski Szpital Specjalityczny im. Jana Pawla II
Krakow , 31-20, Poland
Mazowieckie Centrum Leczenia Chorob Pluc
Otwock , 05-40, Poland
Private Specialist Hospitals - MedPolonia
Poznan , 60-69, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Hospital de Braga
Braga , 4710-, Portugal
Hospital da Luz, SA
Lisboa , 1500-, Portugal
Hosp. Cuf Descobertas
Lisboa , 1998-, Portugal
Hospital Pedro Hispano
Senhora da Hora, , 4464-, Portugal
Hospital Teresa Herrera
A Coruña , 15006, Spain
Hosp. Gral. Univ. de Alicante
Alicante , 03010, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Clinic I Provincial de Barcelona
Barcelona , 08036, Spain
Hosp. Univ. Quiron Dexeus
Barcelona , 8028, Spain
Hosp. Reina Sofia
Córdoba , 14004, Spain
Hosp. Univ. Insular de Gran Canaria
Las Palmas de Gran Canaria , 35016, Spain
Hosp. Univ. Lucus Augusti
Lugo , 27003, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28009, Spain
Hosp. Univ. La Paz
Madrid , 28046, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda , 28222, Spain
Hosp. Regional Univ. de Malaga
Malaga , 29010, Spain
Hosp. Univ. Central de Asturias
Oviedo , 33006, Spain
Hosp. Univ. Son Espases
Palma de Mallorca , 07120, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain
Hosp. Univ. I Politecni La Fe
Valencia , 46026, Spain
Changhua Christian Hospital
Changhua , 50006, Taiwan
Chang Kung Memorial Hospital
Kaohsiung City , 833, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 80756, Taiwan
Chung Shan Medical University Hospital
Taichung , 403, Taiwan
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
National Taiwan University Hospital
Taipei City , 10048, Taiwan
National Taiwan University Cancer Center
Taipei City , 106, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan , 33382, Taiwan
Phramongkutklao Hospital and Medical College
Bangkok , 10400, Thailand
Siriraj Hospital
Bangkok , 10700, Thailand
Chiang Mai University
Chiangmai , 50200, Thailand
Adana City Hospital
Adana , 01060, Turkey
Adana Baskent Yuregir Hospital
Adana , 01120, Turkey
Memorial Ankara Hastanesi
Ankara , 06520, Turkey
Gazi University Hospital
Ankara , 06560, Turkey
Ankara Bilkent City Hospital
Ankara , 06590, Turkey
Trakya University Medical Faculty
Edirne , 22030, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Acıbadem Maslak Hospital
Istanbul , 34457, Turkey
Dokuz Eylul University Medical Faculty
Izmir , 35330, Turkey
IEU Medical Point Hospital
Izmir , 35575, Turkey
Medical Park Samsun Hastanesi
Samsun , 55200, Turkey
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Imperial College Healthcare
London , W2 1N, United Kingdom
The Christie Nhs Foundation Trust
Manchester , M20 4, United Kingdom
Newcastle Freeman Hospital
Newcastle Upon Tyne , NE7 7, United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

640

Study ID:

NCT05388669

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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