NCT05498428RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 520 (estimated)
- First submitted
- 10 Aug 2022
- Start date
- 11 Nov 2022
- Primary completion date
- 17 Aug 2027
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Lung cancer
- NCT number
- NCT05498428
- EU CT number
- 2023-505065-91-00
- EudraCT number
- 2022-000526-21
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 520
- From 11 Nov 2022 to the primary completion date, 17 Aug 2027
- 108 sites in 12 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 a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort
- Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary
- For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1
- Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (less than or equal to \[\<=\] 10 milligrams per day \[mg/day\] prednisone or equivalent) for at least 2 weeks prior to treatment allocation
Other illness
- Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis
- Other clinically active liver disease of infectious origin
Lab values
- Participant has a history of clinically significant cardiovascular disease including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment(s), or any of the following within 6 months prior to the first dose of study treatment(s): myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary; b) All cohorts (with regimens potentially including lazertinib): Participant has a significant genetic predisposition to venous thromboembolic events (VTE; such as Factor V Leiden); c) All cohorts (with regimens potentially including lazertinib): Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected QT interval by Fridericia (QTcF) interval greater than (\>) 480 milliseconds (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood pressure \>160 millimeter(s) of mercury (mmHg); diastolic blood pressure \>100 mmHg; f) Congestive heart failure defined as NYHA class III-IV or hospitalization for congestive heart failure (CHF) (any New York Heart Association \[NYHA\] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically significant pericardial effusion; h) myocarditis; i) baseline left ventricular ejection fraction (LVEF) below the institution's lower limit of normal at screening, as assessed by echocardiogram or multigated acquisition (MUGA) scan
Who the study is looking for
- Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by 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 states \[US\]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor
- All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy
- May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions
- Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1
- Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment
- A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Participants with child bearing potential should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (108)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacao Pio XII Coordinator of this site? Confirm its status | Barretos | Brazil | Recruiting |
| PERSONAL Oncologia de Precisao e Personalizada Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| Hospital do Câncer de Londrina Coordinator of this site? Confirm its status | Londrina | Brazil | Recruiting |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| IDOR - Regional Rio de Janeiro Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| IDOR - Regional Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Impar Servicos Hospitalares SA Hospital Nove de Julho Coordinator of this site? Confirm its status | São Paulo | Brazil | Completed |
| Fundacao Antonio Prudente A C Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hospital Alemão Oswaldo Cruz Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Affiliated Hospital of Hebei University Coordinator of this site? Confirm its status | Baoding | China | Completed |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The First Affiliated Hospital of PLA Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital Zhejiang University College of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| Huizhou Municipal Central Hospital Coordinator of this site? Confirm its status | Huizhou | China | Recruiting |
| Liuzhou People's Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Completed |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Hospital of Jiangnan University Coordinator of this site? Confirm its status | Wuxi | China | Completed |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| LungenClinic Grosshansdorf GmbH Coordinator of this site? Confirm its status | Grosshansdorf | Germany | Recruiting |
| Lungenfachklinik Immenhausen Coordinator of this site? Confirm its status | Immenhausen | Germany | Recruiting |
| Klinikum Wuerzburg Mitte gGmbH Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | St Herblain | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Cheltenham General Hospital Coordinator of this site? Confirm its status | Cheltenham | United Kingdom | Completed |
| Torbay Hospital-Devon Coordinator of this site? Confirm its status | Devon | United Kingdom | Recruiting |
| Edinburgh Cancer Centre Western General Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Recruiting |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| University College London Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Queen Alexandra Hospital Coordinator of this site? Confirm its status | Portsmouth | United Kingdom | Recruiting |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Completed |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| National Hospital Organization Himeji Medical Center Coordinator of this site? Confirm its status | Himeji | Japan | Active, not recruiting |
| Saiseikai Matsusaka Municipal Hospital Coordinator of this site? Confirm its status | Matsusaka | Japan | Active, not recruiting |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Active, not recruiting |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Shizuoka | Japan | Active, not recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Active, not recruiting |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Active, not recruiting |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| Hospital Tengku Ampuan Afzan Coordinator of this site? Confirm its status | Kuantan | Malaysia | Recruiting |
| Hospital Umum Sarawak Coordinator of this site? Confirm its status | Kuching | Malaysia | Recruiting |
| Beacon Hospital Sdn Bhd Coordinator of this site? Confirm its status | Petaling Jaya | Malaysia | Recruiting |
| Sidney Kimmel Cancer Center - Bayview Campus Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Baptist Lynn Cancer Institute Coordinator of this site? Confirm its status | Boca Raton | United States | Completed |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Novant Health 1 Coordinator of this site? Confirm its status | Charlotte | United States | Completed |
| Cleveland Clinic 1 Coordinator of this site? Confirm its status | Cleveland | United States | Completed |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Completed |
| Hematology-Oncology Associates of CNY Coordinator of this site? Confirm its status | East Syracuse | United States | Completed |
| Providence Regional Cancer Partnership Coordinator of this site? Confirm its status | Everett | United States | Completed |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| University of California at San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Cleveland Clinic 2 Coordinator of this site? Confirm its status | Mayfield Heights | United States | Completed |
| Mount Sinai Medical Center Coordinator of this site? Confirm its status | Miami Beach | United States | Recruiting |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| AdventHealth Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| The Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Completed |
| Swedish Cancer Institute Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Virginia Mason Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Completed |
| Stanford Cancer Institute Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| H. Lee Moffitt Cancer & Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Completed |
| Cleveland Clinic 3 Coordinator of this site? Confirm its status | Warrensville Heights | United States | Completed |
| Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
| Novant Health Coordinator of this site? Confirm its status | Winston-Salem | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.