Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (108)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundacao Pio XII
Coordinator of this site? Confirm its status
BarretosBrazilRecruiting
PERSONAL Oncologia de Precisao e Personalizada
Coordinator of this site? Confirm its status
Belo HorizonteBrazilRecruiting
Hospital do Câncer de Londrina
Coordinator of this site? Confirm its status
LondrinaBrazilRecruiting
Hospital Moinhos de Vento
Coordinator of this site? Confirm its status
Porto AlegreBrazilRecruiting
IDOR - Regional Rio de Janeiro
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilRecruiting
IDOR - Regional Bahia
Coordinator of this site? Confirm its status
SalvadorBrazilRecruiting
Impar Servicos Hospitalares SA Hospital Nove de Julho
Coordinator of this site? Confirm its status
São PauloBrazilCompleted
Fundacao Antonio Prudente A C Camargo Cancer Center
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
Hospital Alemão Oswaldo Cruz
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
Affiliated Hospital of Hebei University
Coordinator of this site? Confirm its status
BaodingChinaCompleted
Jilin Cancer Hospital
Coordinator of this site? Confirm its status
ChangchunChinaRecruiting
Sichuan Cancer Hospital
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
The First Affiliated Hospital of PLA Army Medical University
Coordinator of this site? Confirm its status
ChongqingChinaRecruiting
The First Affiliated Hospital, Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The First Affiliated Hospital Zhejiang University College of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Harbin Medical University Cancer Hospital
Coordinator of this site? Confirm its status
HarbinChinaRecruiting
Huizhou Municipal Central Hospital
Coordinator of this site? Confirm its status
HuizhouChinaRecruiting
Liuzhou People's Hospital
Coordinator of this site? Confirm its status
LiuzhouChinaCompleted
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Tianjin Medical University General Hospital
Coordinator of this site? Confirm its status
TianjinChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaRecruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
Hospital of Jiangnan University
Coordinator of this site? Confirm its status
WuxiChinaCompleted
The First Affiliated Hospital of Xian Jiaotong University
Coordinator of this site? Confirm its status
Xi'anChinaRecruiting
Yantai Yuhuangding Hospital
Coordinator of this site? Confirm its status
YantaiChinaCompleted
University Hospital Cologne AöR
Coordinator of this site? Confirm its status
CologneGermanyRecruiting
LungenClinic Grosshansdorf GmbH
Coordinator of this site? Confirm its status
GrosshansdorfGermanyRecruiting
Lungenfachklinik Immenhausen
Coordinator of this site? Confirm its status
ImmenhausenGermanyRecruiting
Klinikum Wuerzburg Mitte gGmbH
Coordinator of this site? Confirm its status
WuerzburgGermanyRecruiting
Complexo Hospitalario Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainRecruiting
Hospital General Universitario Dr. Balmis
Coordinator of this site? Confirm its status
AlicanteSpainRecruiting
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital del Mar
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Institut Catala D'oncologia
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Regional de Málaga
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
Hospital Universitario Virgen De La Macarena
Coordinator of this site? Confirm its status
SevillaSpainRecruiting
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Hospital General Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Centre Francois Baclesse
Coordinator of this site? Confirm its status
Caen Cedex 5FranceRecruiting
Centre Hospitalier Universitaire De Nimes
Coordinator of this site? Confirm its status
Nimes Cedex 9FranceRecruiting
Institut Curie
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Institut De Cancerologie De L Ouest
Coordinator of this site? Confirm its status
St HerblainFranceRecruiting
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting
Cheltenham General Hospital
Coordinator of this site? Confirm its status
CheltenhamUnited KingdomCompleted
Torbay Hospital-Devon
Coordinator of this site? Confirm its status
DevonUnited KingdomRecruiting
Edinburgh Cancer Centre Western General
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting
Leicester Royal Infirmary
Coordinator of this site? Confirm its status
LeicesterUnited KingdomRecruiting
University College London Hospitals
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
Nottingham City Hospital
Coordinator of this site? Confirm its status
NottinghamUnited KingdomRecruiting
Queen Alexandra Hospital
Coordinator of this site? Confirm its status
PortsmouthUnited KingdomRecruiting
Rambam Medical Center
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Shaare Zedek Medical Center
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Meir Medical Center
Coordinator of this site? Confirm its status
Kfar SabaIsraelCompleted
Rabin Medical Center
Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
Sheba medical center
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
IRCCS Ospedale Policlinico San Martino
Coordinator of this site? Confirm its status
GenoaItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
Coordinator of this site? Confirm its status
MonzaItalyRecruiting
Azienda Ospedaliera dei Colli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
National Hospital Organization Himeji Medical Center
Coordinator of this site? Confirm its status
HimejiJapanActive, not recruiting
Saiseikai Matsusaka Municipal Hospital
Coordinator of this site? Confirm its status
MatsusakaJapanActive, not recruiting
Niigata Cancer Center Hospital
Coordinator of this site? Confirm its status
NiigataJapanActive, not recruiting
Shizuoka Cancer Center
Coordinator of this site? Confirm its status
ShizuokaJapanActive, not recruiting
The Cancer Institute Hospital of JFCR
Coordinator of this site? Confirm its status
TokyoJapanActive, not recruiting
Wakayama Medical University Hospital
Coordinator of this site? Confirm its status
WakayamaJapanActive, not recruiting
National Cancer Center
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaRecruiting
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaRecruiting
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaCompleted
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
University Malaya Medical Centre
Coordinator of this site? Confirm its status
Kuala LumpurMalaysiaRecruiting
Hospital Tengku Ampuan Afzan
Coordinator of this site? Confirm its status
KuantanMalaysiaRecruiting
Hospital Umum Sarawak
Coordinator of this site? Confirm its status
KuchingMalaysiaRecruiting
Beacon Hospital Sdn Bhd
Coordinator of this site? Confirm its status
Petaling JayaMalaysiaRecruiting
Sidney Kimmel Cancer Center - Bayview Campus
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Baptist Lynn Cancer Institute
Coordinator of this site? Confirm its status
Boca RatonUnited StatesCompleted
Boston Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Novant Health 1
Coordinator of this site? Confirm its status
CharlotteUnited StatesCompleted
Cleveland Clinic 1
Coordinator of this site? Confirm its status
ClevelandUnited StatesCompleted
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesCompleted
Hematology-Oncology Associates of CNY
Coordinator of this site? Confirm its status
East SyracuseUnited StatesCompleted
Providence Regional Cancer Partnership
Coordinator of this site? Confirm its status
EverettUnited StatesCompleted
Virginia Cancer Specialists
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesRecruiting
University of California at San Diego
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
Cleveland Clinic 2
Coordinator of this site? Confirm its status
Mayfield HeightsUnited StatesCompleted
Mount Sinai Medical Center
Coordinator of this site? Confirm its status
Miami BeachUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey
Coordinator of this site? Confirm its status
New BrunswickUnited StatesRecruiting
University of California Irvine
Coordinator of this site? Confirm its status
OrangeUnited StatesRecruiting
AdventHealth
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
The Huntsman Cancer Institute
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesCompleted
Swedish Cancer Institute
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Virginia Mason Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesCompleted
Stanford Cancer Institute
Coordinator of this site? Confirm its status
StanfordUnited StatesRecruiting
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
H. Lee Moffitt Cancer & Research Institute
Coordinator of this site? Confirm its status
TampaUnited StatesCompleted
Cleveland Clinic 3
Coordinator of this site? Confirm its status
Warrensville HeightsUnited StatesCompleted
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting
University of Kansas Cancer Center
Coordinator of this site? Confirm its status
WestwoodUnited StatesRecruiting
Novant Health
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesCompleted

This page is information, not medical advice. Discuss any trial with your doctor.