A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

Running, not enrolling · Phase 3

Conditions studied: Advanced or Metastatic Non-small Cell Lung Cancer

In brief

The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

Key facts

Study ID

NCT05388669

Run by

Janssen Research & Development, LLC

People needed

418

Starts

2022-08-05

Expected to finish

2027-06-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an 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 Started [US]) or an accredited local laboratory (sites outside of the US)
• Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease
• Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1
• Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
• Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement)

You may not qualify if…

• Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors
• Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
• Participant has symptomatic or progressive brain metastases
• Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
• Participant has uncontrolled tumor-related pain
• Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Where it is running

• City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
• City of Hope Long Beach Elm — Long Beach, California, United States
• National Jewish Health — Denver, Colorado, United States
• Baptist Lynn Cancer Institute — Boca Raton, Florida, United States
• Orlando Health — Orlando, Florida, United States
• University of Kansas — Kansas City, Kansas, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Astera Cancer Care — East Brunswick, New Jersey, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• NYU Langone Health Laura and Isaac Perlmutter Cancer Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Providence Oncology and Hematology Care Clinic Westside — Portland, Oregon, United States
• University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• CEMIC (Centro de Educación Médica e Investigaciones Clínicas) — Buenos Aires, Argentina
• Centro Oncológico Korben — Buenos Aires, Argentina
• IADT Instituto Argentino de Diagnostico y Tratamiento — CABA, Argentina
• Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica — Córdoba, Argentina
• Sanatorio Allende — Córdoba, Argentina
• Clínica Viedma — Viedma, Argentina
• Cancer Research SA — Adelaide, Australia
• Chris O'Brien Lifehouse — Camperdown, Australia
• City of Hope Duarte — Duarte, California, United States

Full record on ClinicalTrials.gov

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