NCT05663866

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-05-18
• Primary completion: 2024-03-29
• Completion: 2026-07-30
• First posted: 2022-12-23
• Last updated: 2026-04-13
• Results posted: 2025-10-20

Locations

36 sites across 5 countries: United States, France, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study