A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
NCT ID: NCT05498428
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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RECRUITING
PHASE2
520 participants
INTERVENTIONAL
2022-11-11
2027-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + Lazertinib
Participants with treatment-naive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) exon 19 deletion (exon19del) or exon 21 leucine 858 to arginine substitution (exon 21 L858R) mutation, will receive amivantamab SC-CF injection, 1600 milligrams (mg) or 2240 mg if body weight is greater than or equal to (\>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily. Eligible participants will be given an option to enter long-term extension (LTE) phase and may continue to receive access to study treatment(s) within the study by transferring to the Drug Access (DA)-LTE Phase.
Amivantamab
Amivantamab will be administered subcutaneously by manual injection.
Lazertinib
Lazertinib will be administered as an oral tablet.
Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy
Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR exon20ins mutation will receive Amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle, starting with Cycle 2 along with pemetrexed 500 milligrams per meter square (mg/m\^2) as intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and IV infusion carboplatin area under the concentration-time curve 5 milligrams per milliliters (mg/mL) per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Amivantamab
Amivantamab will be administered subcutaneously by manual injection.
Carboplatin
Carboplatin will be administrated by IV infusion.
Pemetrexed
Pemetrexed will be administered by IV infusion.
Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy
Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR TKI (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m\^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Lazertinib 240 mg orally once daily starting Cycle 5 Day 1 when carboplatin is complete or sooner if carboplatin discontinued earlier than Cycle 4. Eligible participants will be given an option to enter LTE phase and DA-LTE Phase.
Amivantamab
Amivantamab will be administered subcutaneously by manual injection.
Lazertinib
Lazertinib will be administered as an oral tablet.
Carboplatin
Carboplatin will be administrated by IV infusion.
Pemetrexed
Pemetrexed will be administered by IV infusion.
Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy
Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR TKI (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m\^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Amivantamab
Amivantamab will be administered subcutaneously by manual injection.
Carboplatin
Carboplatin will be administrated by IV infusion.
Pemetrexed
Pemetrexed will be administered by IV infusion.
Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W)
Participants who were previously on amivantamab IV once every 2 weeks (Q2W) regimen as part of standard of care, for at least 8 weeks, either as monotherapy or combination with lazertinib, will receive amivantamab SC-CF injection 1600 mg and 2240 mg if body weight is greater than or equal to 80 kg. Participants who continue to benefit from study treatments, as determined by their investigator, may shift to the drug access (DA)-LTE phase.
Amivantamab
Amivantamab will be administered subcutaneously by manual injection.
Lazertinib
Lazertinib will be administered as an oral tablet.
Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib
Participants with treatment-naïve locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation will receive amivantamab SC-CF induction with 1,600 mg (or 2,240 mg if BW \>=80 kg) on Cycle 1 Days 1, 8, 15, and 22, starting with Cycle 2 on Day 1 of each next 28-day cycle, amivantamab SC-CF (160 mg/mL co-formulated with rHuPH20) by manual injection at 3,520 mg (or 4,640 mg if BW \>=80 kg); along with lazertinib 240 mg by mouth once daily from Cycle 1 Day 1. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Amivantamab
Amivantamab will be administered subcutaneously by manual injection.
Lazertinib
Lazertinib will be administered as an oral tablet.
Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant
Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation treated will receive will receive amivantamab SC-CF injection, 1600 milligrams (mg) and 2240 mg if body weight is greater than or equal to (\>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily from Cycle 1 Day 1. Participants will additionally take prophylactic anticoagulation with a direct oral anticoagulant (DOAC) or a low molecular weight heparin (LMWH) for the first four months of study treatment (from Day 1 through Day 120) with the combination of amivantamab and lazertinib. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Amivantamab
Amivantamab will be administered subcutaneously by manual injection.
Lazertinib
Lazertinib will be administered as an oral tablet.
Direct Oral Anticoagulant (DOAC)
DOAC will be administered orally.
Low Molecular Weight Heparin (LMWH)
LMWH will be administered subcutaneously.
Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy
Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after the combination of amivantamab and lazertinib will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m\^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Amivantamab
Amivantamab will be administered subcutaneously by manual injection.
Carboplatin
Carboplatin will be administrated by IV infusion.
Pemetrexed
Pemetrexed will be administered by IV infusion.
Interventions
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Amivantamab
Amivantamab will be administered subcutaneously by manual injection.
Lazertinib
Lazertinib will be administered as an oral tablet.
Carboplatin
Carboplatin will be administrated by IV infusion.
Pemetrexed
Pemetrexed will be administered by IV infusion.
Direct Oral Anticoagulant (DOAC)
DOAC will be administered orally.
Low Molecular Weight Heparin (LMWH)
LMWH will be administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Other clinically active liver disease of infectious origin
* 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
* 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
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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University of California at San Diego
La Jolla, California, United States
University of California Irvine
Orange, California, United States
Stanford Cancer Institute
Stanford, California, United States
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Baptist Lynn Cancer Institute
Boca Raton, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
AdventHealth
Orlando, Florida, United States
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Sidney Kimmel Cancer Center - Bayview Campus
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States
Novant Health
Charlotte, North Carolina, United States
Novant Health
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Cleveland Clinic
Mayfield Heights, Ohio, United States
Cleveland Clinic
Warrensville Heights, Ohio, United States
The Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Fundacao Pio XII
Barretos, , Brazil
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, , Brazil
Instituto do Cancer de Londrina Hospital do Cancer de Londrina
Londrina, , Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, , Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, , Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Salvador, , Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, , Brazil
Impar Servicos Hospitalares SA Hospital Nove de Julho
São Paulo, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, , Brazil
Affiliated Hospital of Hebei University
Baoding, , China
Jilin cancer hospital
Changchun, , China
Sichuan Cancer Hospital
Chengdu, , China
West China Hospital Sichuan University
Chengdu, , China
The First Affiliated Hospital of PLA Army Medical University
Chongqing, , China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, , China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
Harbin medical university cancer hospital
Harbin, , China
Huizhou Municipal Central Hospital
Huizhou, , China
Liuzhou people's Hospital
Liuzhou, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
Hospital of Jiangnan University
Wuxi, , China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, , China
Yantai Yuhuangding Hospital
Yantai, , China
Centre Francois Baclesse
Caen, , France
Centre Georges-François Leclerc
Dijon, , France
Institut de Cancérologie du Gard
Nîmes, , France
Institut Curie
Paris, , France
Institut de cancerologie de l'ouest
Saint-Herblain, , France
Gustave Roussy
Villejuif, , France
Evangelische Lungenklinik Berlin
Berlin, , Germany
Universitaetsklinikum Koelnt
Cologne, , Germany
LungenClinic Grosshansdorf GmbH
Grosshandorf, , Germany
Lungenfachklinik Immenhausen
Immenhausen, , Germany
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Würzburg, , Germany
Rambam Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Policlinico Hospital San Martino- IRCCS for Oncology
Genova, , Italy
Ospedale San Raffaele
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliera San Gerardo
Monza, , Italy
Azienda Ospedaliera Specialistica dei Colli
Naples, , Italy
National Hospital Organization Himeji Medical Center
Himeji, , Japan
Matsusaka Municipal Hospital
Matsusaka, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Hospital Umum Sarawak
Kuching, , Malaysia
Beacon Hospital Sdn Bhd
Petaling Jaya, , Malaysia
National Cancer Center
Goyang-si, , 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
Hosp Univ A Coruna
A Coruña, , Spain
General University Hospital of Alicantet
Alicante, , Spain
Hosp. Del Mar
Barcelona, , Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, , Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Univ. La Paz
Madrid, , Spain
Hosp Regional Univ de Malaga
Málaga, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Hosp. Clinico Univ. de Valencia
Valencia, , Spain
Hosp. Gral. Univ. Valencia
Valencia, , Spain
Cheltenham General Hospital
Cheltenham, , United Kingdom
Torbay Hospital-Devon
Devon, , United Kingdom
Edinburgh Cancer Centre Western General
Edinburgh, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
University College London Hospitals
London, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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61186372NSC2002
Identifier Type: OTHER
Identifier Source: secondary_id
2022-000526-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505065-91-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109264
Identifier Type: -
Identifier Source: org_study_id