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NCT05498428From ClinicalTrials.govRecruiting

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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A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Fac | Trialion