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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLazertinib and Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 28, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?187 U.S. locations

Locations may change over time.

Who runs it?Janssen Research & Development, LLC

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Janssen Research & Development, LLC
Interventions being studied: Drug: Lazertinib; Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF); Drug: Amivantamab Intravenous

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

EGFR→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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)

Reasons someone may not be able to joinExclusion criteria

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

City of Hope DuarteDuarte, California
City of Hope Orange County Lennar Foundation Cancer CenterIrvine, California
City of Hope Long Beach ElmLong Beach, California
National Jewish HealthDenver, Colorado
Baptist Lynn Cancer InstituteBoca Raton, Florida
Orlando HealthOrlando, Florida
University of KansasKansas City, Kansas
University of MichiganAnn Arbor, Michigan
Astera Cancer CareEast Brunswick, New Jersey
Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
NYU Langone Health Laura and Isaac Perlmutter Cancer CenterNew York, New York
Montefiore Medical CenterThe Bronx, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 28, 2026. Always confirm current availability with the study team.

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