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RECRUITING Phase 2 ClinicalTrials.gov

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT05498428

Registry updated: 2026-09-28
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Description

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).

Interventions

  • Amivantamab (Drug)
    Amivantamab will be administered subcutaneously by manual injection.
  • Lazertinib (Drug)
    Lazertinib will be administered as an oral tablet.
  • Carboplatin (Drug)
    Carboplatin will be administrated by IV infusion.
  • Pemetrexed (Drug)
    Pemetrexed will be administered by IV infusion.
  • Direct Oral Anticoagulant (DOAC) (Drug)
    DOAC will be administered orally.
  • Low Molecular Weight Heparin (LMWH) (Drug)
    LMWH will be administered subcutaneously.

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

Conditions

Carcinoma, Non-small-Cell Lung

Locations

  • 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 1 — Charlotte, North Carolina, United States
  • Novant Health — Winston-Salem, North Carolina, United States
  • Cleveland Clinic 1 — Cleveland, Ohio, United States
  • Cleveland Clinic — Cleveland, Ohio, United States
  • Cleveland Clinic 2 — Mayfield Heights, Ohio, United States
  • Cleveland Clinic 3 — 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
  • Hospital do Cancer de Londrina — Londrina, Brazil
  • Hospital Moinhos de Vento — Porto Alegre, Brazil
  • IDOR - Regional Rio de Janeiro — Rio de Janeiro, Brazil
  • IDOR - Regional Bahia — 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 Koeln — 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
  • Saiseikai 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record