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ACTIVE NOT RECRUITING
NCT05663866
PHASE2

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

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.

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