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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Dexamethasone will be administered orally.
Montelukast will be administered orally.
Methotrexate will be administered subcutaneously.
Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1
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.
Time frame: Cycle 1 Day 1 (each cycle of 28 days)
Percentage of Participants With Adverse Events of Infusion-related Reactions (IRRs) During Cycle 1 Day 1
Time frame: Cycle 1 Day 1 (each cycle of 28 days)
Percentage of Participants With Adverse Events (AEs) of Infusion-related Reactions (IRRs) as Per Severity up to End of Cycle 3 (Cycle 3 Day 28)
Time frame: From Cycle 1 Day 1 up to Cycle 3 Day 28 (each cycle of 28 days)
Percentage of Participants With IRRs up to End of Treatment (EOT)
Time frame: From Cycle 1 Day 1 (each cycle of 28 days) up to 27.3 months
Percentage of Participants With Other Adverse Events (AEs): Non-IRRs
Time frame: From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months
Duration of Infusion Time for Pre-amivantamab Infusion Medications, IV Amivantamab Infusion, and Post-amivantamab Infusion Medications on Cycle 1 Day 1
Time frame: Cycle 1 Day 1 (each cycle of 28 days)
Percentage of Participants Completing Amivantamab Infusion Within 4 Hours on Cycle 1 Day 1
Time frame: Up to 4 hours on Cycle 1 Day 1 (each cycle of 28 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Amivantamab will be administered intravenously.
Lazertinib tablets will be administered orally.
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
...and 26 more locations
Overall Response Rate (ORR)
Time frame: From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months
Duration of Response (DOR)
Time frame: From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months