Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Study summary

The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of first-dose infusion related reactions.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDexamethasone and Montelukast

Plus 3 other study approaches.

Who it may be forCarcinoma, Non-Small-Cell Lung

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 25, 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 2

Interventional

Where is it offered?36 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 2
Sponsor: Janssen Research & Development, LLC
Interventions being studied: Drug: Dexamethasone; Drug: Montelukast; Drug: Methotrexate; Drug: Amivantamab; Drug: Lazertinib

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How this study is categorized

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

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

Participant must have advanced or metastatic non-small cell lung cancer (NSCLC)
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
A female participant using oral contraceptives must use an additional barrier contraceptive method
A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 3 months after receiving the last dose of study treatment, oral lazertinib and intravenous (IV) Amivantamab
Each participant, or legally authorized representative, where allowed, must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Progressed on or after prior treatment with osimertinib and platinum-based chemotherapy. Prior use of first-or-second generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) is allowed if administered prior to osimertinib
Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments \[CLIA\]-certified laboratory \[or equivalent\])

Reasons someone may not be able to joinExclusion criteria

Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
Prior treatment with anti PD-1 or anti PD-L1 antibody within 6 weeks of planned first dose of study treatment or immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment
Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed. If brain metastases are diagnosed on Screening imaging, the participant may be enrolled, or rescreened for eligibility, after definitive treatment if above criteria are met
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 therapy)
Prior treatment with amivantamab or lazertinib

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

Compassionate Cancer CareFountain Valley, California
Virginia Cancer SpecialistsFairfax, Virginia
UW Medicine Valley Medical CenterRenton, Washington
CHU de Brest - Hopital de la Cavale BlancheBrest
Centre Leon BerardLyon
Hopital CochinParis
Hopital Europeen Georges-PompidouParis
CHU Rouen Hopital Charles NicolleRouen
Nouvel Hopital Civil - CHU StrasbourgStrasbourg
Chungbuk National University HospitalCheongju-si
National Cancer CenterGyeonggi-do
Gachon University Gil Medical CenterIncheon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 25, 2026. Always confirm current availability with the study team.

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