NCT05388669Active, not recruitingPhase 3
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
A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 418 (actual)
- First submitted
- 19 May 2022
- Start date
- 5 Aug 2022
- Primary completion date
- 3 Jan 2024
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Lung cancer
- NCT number
- NCT05388669
- EU CT number
- 2024-512045-16-00
- EudraCT number
- 2022-000525-25
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 418
- From 5 Aug 2022 to the primary completion date, 3 Jan 2024
- 152 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
- Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
Other illness
- Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
Lab values
- Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors
Other
- Participant has symptomatic or progressive brain metastases
- Participant has uncontrolled tumor-related pain
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (152)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CEMIC (Centro de Educación Médica e Investigaciones Clínicas) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| IADT Instituto Argentino de Diagnostico y Tratamiento Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro Oncológico Korben Coordinator of this site? Confirm its status | Chabas | Argentina | Unknown status |
| Sanatorio Allende Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Clínica Viedma Coordinator of this site? Confirm its status | Viedma | Argentina | Unknown status |
| Cancer Research SA Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Chris O'Brien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| St John of God Hospital Murdoch Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Fundacao Pio XII Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Cetus Oncologia Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Instituto Cionc de Ensino e Pesquisa S/S Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Ynova Pesquisa Clinica Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| Fundacao Sao Francisco Xavier HMC Unidade de Oncologia Coordinator of this site? Confirm its status | Ipatinga | Brazil | Unknown status |
| UPCO Unidade de Pesquisa Clinica em Oncologia Coordinator of this site? Confirm its status | Pelotas | Brazil | Unknown status |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto D Or de Pesquisa e Ensino IDOR Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Impar Servicos Hospitalares S/A Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Oncoclinicas Rio de Janeiro S A Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Nucleo de Oncologia da Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| Núcleo de Pesquisa São Camilo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Impar Servicos Hospitalares SA Hospital Nove de Julho Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Onco Star SP Oncologia Ltda Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Beijing Shijitan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing chest hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The First People's Hospital Of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Southwest Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| First Affiliated Hospital Of Gannan Medical University Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University College of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Huizhou First Hospital Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| Huizhou Municipal Central Hospital Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| Liuzhou People's Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
| Affiliated Hospital of North Sichuan Medical College Coordinator of this site? Confirm its status | Nanchong | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shenzhen university General Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Giessen | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Birmingham Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Imperial College Healthcare Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Newcastle Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Yeruham | Israel | Unknown status |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| National Hospital Organization Himeji Medical Center Coordinator of this site? Confirm its status | Himeji | Japan | Unknown status |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Hirakata | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Kurashiki Central Hospital Coordinator of this site? Confirm its status | Kurashiki | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Matsusaka Municipal Hospital Coordinator of this site? Confirm its status | Matsusaka | Japan | Unknown status |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| National Hospital Organization Osaka Toneyama Medical Center Coordinator of this site? Confirm its status | Toyonaka-shi | Japan | Unknown status |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| National Hospital Organization Yamaguchi Ube Medical Center Coordinator of this site? Confirm its status | Yamaguchi | Japan | Unknown status |
| National Hospital Organization Iwakuni Clinical Center Coordinator of this site? Confirm its status | Yamaguchi | Japan | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| CHA Bundang Medical Center, CHA University Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Gyeongsangnam-do | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Prince Court Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Pantai Hospital Kuala Lumpur Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Umum Sarawak Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Beacon Hospital Sdn Bhd Coordinator of this site? Confirm its status | Petaling Jaya | Malaysia | Unknown status |
| Sunway Medical Centre Coordinator of this site? Confirm its status | Petaling Jaya | Malaysia | Unknown status |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Hospital Cuf Descobertas S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Unidade Local De Saude De Matosinhos E.P.E. Coordinator of this site? Confirm its status | Senhora Da Hora | Portugal | Completed |
| Phramongkutklao Hospital and Medical College Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chiang Mai University Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chang Kung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Cancer Center Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Baptist Lynn Cancer Institute Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| City of Hope - Duarte Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Astera Cancer Care Coordinator of this site? Confirm its status | East Brunswick | United States | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| City of Hope Orange County Lennar Foundation Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| University of Kansas Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| City of Hope Long Beach Elm Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| NYU Langone Health Laura and Isaac Perlmutter Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Orlando Health Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Providence Oncology and Hematology Care Clinic - Westside Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Adana City Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Adana Baskent Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Gazi University Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Memorial Ankara Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara Bilkent City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Trakya University Medical Faculty Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Acıbadem Maslak Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Dokuz Eylul University Medical Faculty Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| IEU Medical Point Hospital Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Medical Park Samsun Hastanesi Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.