Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- 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 with IRRs at Cycle 1 Day 1 was reported. IRRs were defined as IRR events with onset time within 24 hours of the start of the first amivantamab infusion and prior to the start of amivantamab infusion on Cycle 1 Day 2. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Compassionate Cancer Care | Fountain Valley | California | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| UW Medicine Valley Medical Center | Renton | Washington | |
| 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 |
On this site
📄 Singulair (montelukast) drug profile →More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05663866 on ClinicalTrials.gov ↗ ← All trials in Spain