BENITIONSClinical Trial Intelligence

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Phase 2 Active, not recruiting NCT05663866

ConditionCarcinoma, Non-Small-Cell Lung
PhasePhase 2
SponsorJanssen Research & Development, LLC
StatusActive, not recruiting
Enrollment68 participants
InterventionsDexamethasone, Montelukast, Methotrexate, Amivantamab, Lazertinib
Start dateMay 18, 2023
Completion dateMar 29, 2024
Results postedOct 20, 2025

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.

Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1

Cycle 1 Day 1 (each cycle of 28 days) · Percentage of participants

Cohort A: Dexamethasone 4 Milligrams (mg)83.3 Percentage of participants
Cohort A2: Dexamethasone 8 mg22.5 Percentage of participants
Cohort B: Montelukast 10 mg66.7 Percentage of participants
Cohort C: Methotrexate 25 mg83.3 Percentage of participants

Open in BENITIONS View on ClinicalTrials.gov

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