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
- Carcinoma, Non-small-Cell Lung
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 520
- Started
- 11 November 2022
- Main results due
- 17 August 2027
- Study sites
- 110
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis * 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
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(110)
University of California at San Diego
La Jolla, California, United States
Recruiting
University of California Irvine
Orange, California, United States
Recruiting
Stanford Cancer Institute
Stanford, California, United States
Recruiting
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Recruiting
Baptist Lynn Cancer Institute
Boca Raton, Florida, United States
Completed
Mount Sinai Medical Center
Miami Beach, Florida, United States
Recruiting
AdventHealth
Orlando, Florida, United States
Recruiting
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States
Completed
University of Kansas Cancer Center
Westwood, Kansas, United States
Recruiting
Sidney Kimmel Cancer Center - Bayview Campus
Baltimore, Maryland, United States
Recruiting
Boston Medical Center
Boston, Massachusetts, United States
Recruiting
Washington University School Of Medicine
St Louis, Missouri, United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Recruiting
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States
Completed
Novant Health 1
Charlotte, North Carolina, United States
Completed
Novant Health
Winston-Salem, North Carolina, United States
Completed
Cleveland Clinic 1
Cleveland, Ohio, United States
Completed
Cleveland Clinic
Cleveland, Ohio, United States
Completed
Cleveland Clinic 2
Mayfield Heights, Ohio, United States
Completed
Cleveland Clinic 3
Warrensville Heights, Ohio, United States
Completed
The Huntsman Cancer Institute
Salt Lake City, Utah, United States
Completed
Virginia Cancer Specialists
Fairfax, Virginia, United States
Recruiting
Providence Regional Cancer Partnership
Everett, Washington, United States
Completed
Virginia Mason Medical Center
Seattle, Washington, United States
Completed
Swedish Cancer Institute
Seattle, Washington, United States
Recruiting
Fundacao Pio XII
Barretos, Brazil
Recruiting
PERSONAL Oncologia de Precisao e Personalizada
Belo Horizonte, Brazil
Recruiting
Hospital do Cancer de Londrina
Londrina, Brazil
Recruiting
Hospital Moinhos de Vento
Porto Alegre, Brazil
Recruiting
IDOR - Regional Rio de Janeiro
Rio de Janeiro, Brazil
Recruiting
IDOR - Regional Bahia
Salvador, Brazil
Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
Recruiting
Impar Servicos Hospitalares SA Hospital Nove de Julho
São Paulo, Brazil
Completed
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Recruiting
Affiliated Hospital of Hebei University
Baoding, China
Completed
Jilin cancer hospital
Changchun, China
Recruiting
Sichuan Cancer Hospital
Chengdu, China
Recruiting
West China Hospital Sichuan University
Chengdu, China
Recruiting
The First Affiliated Hospital of PLA Army Medical University
Chongqing, China
Recruiting
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China
Recruiting
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, China
Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Recruiting
Harbin medical university cancer hospital
Harbin, China
Recruiting
Huizhou Municipal Central Hospital
Huizhou, China
Recruiting
Liuzhou people's Hospital
Liuzhou, China
Completed
Fudan University Shanghai Cancer Center
Shanghai, China
Recruiting
Tianjin Medical University General Hospital
Tianjin, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
Recruiting
Hospital of Jiangnan University
Wuxi, China
Completed
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Recruiting
Yantai Yuhuangding Hospital
Yantai, China
Completed
Centre Francois Baclesse
Caen, France
Recruiting
Centre Georges-François Leclerc
Dijon, France
Completed
Institut de Cancérologie du Gard
Nîmes, France
Recruiting
Institut Curie
Paris, France
Recruiting
Institut de cancerologie de l'ouest
Saint-Herblain, France
Recruiting
Gustave Roussy
Villejuif, France
Recruiting
Evangelische Lungenklinik Berlin
Berlin, Germany
Completed
Showing 60 of 110 sites — filter to narrow it down. 82 of the 110 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05498428. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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