Clinical trial Recruiting at 82 sites Phase 2 Interventional Ages 18 and up

Evaluating amivantamab for advanced non-small cell lung cancer

Official title: 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

Run by Janssen Research & Development, LLC · NCT05498428 · Data updated 2026-11-12

This study is testing if a new treatment combining amivantamab and another drug can help people with advanced non-small cell lung cancer, especially those with certain genetic mutations.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment520 (estimated)
SponsorJanssen Research & Development, LLC
Industry-sponsored
Drugs / interventionsamivantamab, osimertinib, lazertinib, radiation, prednisone
Locations110 sites (La Jolla, California and 109 other locations)
StatusRecruiting
StartedNovember 11, 2022
Main results expectedAugust 17, 2027
Study endsAugust 18, 2028
Registry record updatedNovember 3, 2026
Trial IDNCT05498428 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with advanced or metastatic non-small cell lung cancer who have specific EGFR mutations and have not received prior systemic therapy or have progressed after previous treatments.

Probably not a fit

Patients with early-stage non-small cell lung cancer or those who have already undergone curative therapies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the effectiveness and safety of amivantamab, administered in combination with recombinant human hyaluronidase PH20, for patients with advanced or metastatic non-small cell lung cancer (NSCLC). Participants will be grouped based on specific genetic mutations, particularly focusing on those with EGFR mutations. The study aims to evaluate the anti-tumor activity of this treatment regimen and its safety profile across different cohorts. Various treatment combinations will be explored, including the use of other cancer therapies.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced non-small cell lung cancer, particularly those with specific EGFR mutations.

How similar studies have gone: Other studies have shown promising results with similar targeted therapies for EGFR-mutated non-small cell lung cancer, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • 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
  • Mount Sinai Medical Center
    Miami Beach, Florida, United States
    Recruiting
  • AdventHealth
    Orlando, Florida, United States
    Recruiting
Show 44 more locations
  • 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
  • Virginia Cancer Specialists
    Fairfax, Virginia, United States
    Recruiting
  • 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
  • Fundacao Antonio Prudente A C Camargo Cancer Center
    São Paulo, Brazil
    Recruiting
  • 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
  • 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
  • The First Affiliated Hospital of Xian Jiaotong University
    Xi'an, China
    Recruiting
  • Centre Francois Baclesse
    Caen, France
    Recruiting
  • 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
  • Universitaetsklinikum Koeln
    Cologne, Germany
    Recruiting
  • LungenClinic Grosshansdorf GmbH
    Grosshandorf, Germany
    Recruiting
  • Lungenfachklinik Immenhausen
    Immenhausen, Germany
    Recruiting
  • Klinikum Würzburg Mitte gGmbH Standort Missioklinik
    Würzburg, Germany
    Recruiting
  • Rambam Medical Center
    Haifa, Israel
    Recruiting
  • Shaare Zedek Medical Center
    Jerusalem, Israel
    Recruiting
  • Rabin Medical Center
    Petah Tikva, Israel
    Recruiting
  • Sheba Medical Center
    Ramat Gan, Israel
    Recruiting
  • Policlinico Hospital San Martino- IRCCS for Oncology
    Genova, Italy
    Recruiting

+60 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.