Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Phase 2 Active not recruiting 68 enrolled Janssen Research & Development, LLC

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2023-05-18
Primary completion: 2024-03-29
Completion: 2027-09-30

Outcome

Met primary endpoint

paper At C1D1, nine of 40 participants (22.5%) experienced IRRs, resulting in an approximately threefold decrease versus historical data (67.4%). PMID 39864547 ↗

paper The dexamethasone 8 mg cohort passed stages 1 and 2 proceeding to the expansion stage PMID 39864547 ↗

Publications

Spira AI, Paz-Ares L, Han JY, Shih JY, Mascaux C, Roy UB, Zugazagoitia J, Kim YJ, Chiu CH, Kim SW, Nadal E, Gil-Bazo I, Murphy SP, Anderson BG, Xia Y, Wang G, Bauml JM, Chioda M, Simoes J, Mahadevia PJ, Lopes G. Preventing Infusion-Related Reactions With Intravenous Amivantamab-Results From SKIPPirr, a Phase 2 Study: A Brief Report. J Thorac Oncol. 2025 Jun;20(6):809-816. doi: 10.1016/j.jtho.2025.01.018. Epub 2025 Jan 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	4 mg	Oral
Subject	Dexamethasone	Small molecule	8 mg	Oral
Subject	Methotrexate	Small molecule	25 mg	Subcutaneous
Subject	Montelukast	Other / unclassified	10 mg	Oral
Background	Amivantamab	Monoclonal antibody	—	Intravenous
Background	Lazertinib	Small molecule	—	Oral