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Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-04-13

Study results available
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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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Dexamethasone

Dexamethasone will be administered orally.

DRUG

Montelukast

Montelukast will be administered orally.

DRUG

Methotrexate

Methotrexate will be administered subcutaneously.

DRUG

Amivantamab

Amivantamab will be administered intravenously.

DRUG

Lazertinib

Lazertinib tablets will be administered orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2024-03-29
Completion
2026-07-30
FDA Drug
Yes

Countries

  • United States
  • France
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663866 on ClinicalTrials.gov