A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
NCT ID: NCT05388669
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
418 participants
INTERVENTIONAL
2022-08-05
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Lazertinib with Amivantamab SC-CF
Lazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase.
Lazertinib
Lazertinib tablets will be administered orally.
Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Amivantamab injection will be administered subcutaneously by manual injection.
Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion
Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase.
Lazertinib
Lazertinib tablets will be administered orally.
Amivantamab Intravenous
Amivantamab will be administered by IV infusion.
Interventions
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Lazertinib
Lazertinib tablets will be administered orally.
Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Amivantamab injection will be administered subcutaneously by manual injection.
Amivantamab Intravenous
Amivantamab will be administered by IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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City of Hope Duarte
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
City of Hope Long Beach Elm
Long Beach, California, United States
National Jewish Health
Denver, Colorado, United States
Baptist Lynn Cancer Institute
Boca Raton, Florida, United States
Orlando Health
Orlando, Florida, United States
University of Kansas
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic Westside
Portland, Oregon, United States
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires, , Argentina
Centro Oncológico Korben
Buenos Aires, , Argentina
IADT Instituto Argentino de Diagnostico y Tratamiento
CABA, , Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, , Argentina
Sanatorio Allende
Córdoba, , Argentina
Clínica Viedma
Viedma, , Argentina
Cancer Research SA
Adelaide, , Australia
Chris O'Brien Lifehouse
Camperdown, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
St John of God Hospital Murdoch
Murdoch, , Australia
Westmead Hospital
Westmead, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Fundacao Pio XII
Barretos, , Brazil
Cetus Oncologia
Belo Horizonte, , Brazil
Instituto Cionc de Ensino e Pesquisa S/S
Curitiba, , Brazil
Ynova Pesquisa Clinica
Florianópolis, , Brazil
Fundacao Sao Francisco Xavier HMC Unidade de Oncologia
Ipatinga, , Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas, , Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, , Brazil
Impar Servicos Hospitalares S/A
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
Nucleo de Oncologia da Bahia
Salvador, , Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, , Brazil
Impar Servicos Hospitalares SA Hospital Nove de Julho
São Paulo, , Brazil
Núcleo de Pesquisa São Camilo
São Paulo, , Brazil
Onco Star SP Oncologia Ltda
São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, , Brazil
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Beijing Shijitan Hospital, Capital Medical University
Beijing, , China
Beijing Friendship Hospital Capital Medical University
Beijing, , China
Peking University Third Hospital
Beijing, , China
Beijing Chest hospital, Capital medical university
Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
Jilin cancer hospital
Changchun, , China
The First People's Hospital Of Changzhou
Changzhou, , China
Sichuan Cancer Hospital
Chengdu, , China
West China Hospital Sichuan University
Chengdu, , China
Chongqing University Cancer Hospital
Chongqing, , China
Southwest Hospital
Chongqing, , China
First Affiliated Hospital of Gannan Medical University
Ganzhou, , China
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
Guangzhou, , China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, , 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
Huizhou Municipal Central Hospital
Huizhou, , China
Huizhou First Hospital
Huizhou, , China
Liuzhou people's Hospital
Liuzhou, , China
Affiliated Hospital of North Sichuan Medical College
Nanchong, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Shengjing Hospital Of China Medical University
Shenyang, , China
Shenzhen People s Hospital
Shenzhen, , China
Shenzhen university General Hospital
Shenzhen, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, , China
Xiangyang Central Hospital
Xiangyang, , China
Yantai Yuhuangding Hospital
Yantai, , China
Henan Cancer Hospital
Zhengzhou, , China
CHU Grenoble
La Tronche, , France
Institute Coeur Poumon
Lille, , France
CHU de Limoges Hopital Dupuytren
Limoges, , France
Hopital Nord
Marseille, , France
Evangelische Lungenklinik Berlin
Berlin, , Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
Georgsmarienhütte, , Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, , Germany
Munster University Hospital
Münster, , Germany
Oncologianova GmbH
Recklinghausen, , Germany
Onkologische Schwerpunktpraxis
Weinsberg, , Germany
Rambam Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
Bari, , Italy
A O U Sant Orsola Malpighi
Bologna, , Italy
European Institute of Oncology
Milan, , Italy
Aou San Luigi Gonzaga
Orbassano, , Italy
Istituto Oncologico Veneto - IRCCS
Padua, , Italy
Ospedale S. Maria Delle Croci
Ravenna, , Italy
A.O. San Camillo Forlanini
Roma, , Italy
Istituto Nazionale Tumori Regina Elena
Rome, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
National Cancer Center Hospital
Chūōku, , Japan
National Hospital Organization Himeji Medical Center
Himeji, , Japan
Kansai Medical University Hospital
Hirakata, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Kurashiki Central Hospital
Kurashiki, , Japan
Kurume University Hospital
Kurume, , Japan
Matsusaka Municipal Hospital
Matsusaka, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Fujita Health University Hospital
Toyoake, , Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka-shi, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
National Hospital Organization Iwakuni Clinical Center
Yamaguchi, , Japan
National Hospital Organization Yamaguchi Ube Medical Center
Yamaguchi, , Japan
Prince Court Medical Centre
Kuala Lumpur, , Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Umum Sarawak
Kuching, , Malaysia
Beacon Hospital Sdn Bhd
Petaling Jaya, , Malaysia
Sunway Medical Centre
Petaling Jaya, , Malaysia
Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
Bydgoszcz, , Poland
Krakowski Szpital Specjalityczny im. Jana Pawla II
Krakow, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc
Otwock, , Poland
Private Specialist Hospitals - MedPolonia
Poznan, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, , Poland
Hospital de Braga
Braga, , Portugal
Hospital da Luz, SA
Lisbon, , Portugal
Hosp. Cuf Descobertas
Lisbon, , Portugal
Ulsm - Hosp. Pedro Hispano
Senhora da Hora, , Portugal
National Cancer Center
Gyeonggi-do, , South Korea
CHA Bundang Medical Center, CHA University
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
Seoul National University 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
Hosp Univ A Coruna
A Coruña, , Spain
Hosp. Gral. Univ. de Alicante
Alicante, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. Univ. Quiron Dexeus
Barcelona, , Spain
Hosp Reina Sofia
Córdoba, , Spain
Hosp. Univ. Insular de Gran Canaria
Las Palmas de Gran Canaria, , Spain
Hosp. Univ. Lucus Augusti
Lugo, , Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , Spain
Hosp. Univ. La Paz
Madrid, , Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, , Spain
Hosp Regional Univ de Malaga
Málaga, , Spain
Hosp. Univ. Central de Asturias
Oviedo, , Spain
Hosp. Univ. Son Espases
Palma de Mallorca, , Spain
Hosp. Virgen Del Rocio
Seville, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Kung Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
National Taiwan University Cancer Center
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Phramongkutklao Hospital and Medical College
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Adana City Hospital
Adana, , Turkey (Türkiye)
Adana Baskent Hospital
Adana, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Gazi University Hospital
Ankara, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Acıbadem Maslak Hospital
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, , Turkey (Türkiye)
IEU Medical Point Hospital
Izmir, , Turkey (Türkiye)
Medical Park Samsun Hastanesi
Samsun, , Turkey (Türkiye)
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Imperial College Healthcare
London, , United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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References
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Leighl NB, Akamatsu H, Lim SM, Cheng Y, Minchom AR, Marmarelis ME, Sanborn RE, Chih-Hsin Yang J, Liu B, John T, Massuti B, Spira AI, Lee SH, Wang J, Li J, Liu C, Novello S, Kondo M, Tamiya M, Korbenfeld E, Moskovitz M, Han JY, Alexander M, Joshi R, Felip E, Voon PJ, Danchaivijitr P, Hsu PC, Silva Melo Cruz FJ, Wehler T, Greillier L, Teixeira E, Nguyen D, Sabari JK, Qin A, Kowalski D, Sendur MAN, Xie J, Ghosh D, Alhadab A, Haddish-Berhane N, Clemens PL, Lorenzini P, Verheijen RB, Gamil M, Bauml JM, Baig M, Passaro A; PALOMA-3 Investigators. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605. doi: 10.1200/JCO.24.01001. Epub 2024 Jun 10.
Other Identifiers
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61186372NSC3004
Identifier Type: OTHER
Identifier Source: secondary_id
2022-000525-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-512045-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109211
Identifier Type: -
Identifier Source: org_study_id