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Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Sponsor: Janssen Research & Development, LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2023-05-18
Completion Date
2026-07-30
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone
Dexamethasone will be administered orally.
Montelukast
Montelukast will be administered orally.
Methotrexate
Methotrexate will be administered subcutaneously.
Amivantamab
Amivantamab will be administered intravenously.
Lazertinib
Lazertinib tablets will be administered orally.
Locations (36)
Compassionate Cancer Care
Fountain Valley, California, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
UW Medicine Valley Medical Center
Renton, Washington, United States
CHU de Brest - Hopital de la Cavale Blanche
Brest, France
Centre Leon Berard
Lyon, France
Hopital Cochin
Paris, France
Hopital Europeen Georges-Pompidou
Paris, France
CHU Rouen Hopital Charles Nicolle
Rouen, France
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg, France
Chungbuk National University Hospital
Cheongju-si, South Korea
National Cancer Center
Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Asan Medical Center
Seoul, South Korea
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp. Univ. Quiron Dexeus
Barcelona, Spain
Hosp. San Pedro de Alcantara
Cáceres, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp Virgen de La Victoria
Málaga, Spain
Hosp. Univ. Son Espases
Palma de Mallorca, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain
Inst. Valenciano de Oncologia
Valencia, Spain
Hosp. Gral. Univ. Valencia
Valencia, Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, Spain
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chi-Mei Medical Center, Liouying
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan