Dexamethasone
DrugDexamethasone will be administered orally.
NCT Number: NCT05663866
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
CHU de Brest - Hopital de la Cavale Blanche, Brest, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexamethasone will be administered orally.
Montelukast will be administered orally.
Methotrexate will be administered subcutaneously.
Amivantamab will be administered intravenously.
Other names: JNJ-61186372
Lazertinib tablets will be administered orally.
Other names: JNJ-73841937
Time frame: 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.
Time frame: Cycle 1 Day 1 (each cycle of 28 days)
Time frame: From Cycle 1 Day 1 up to Cycle 3 Day 28 (each cycle of 28 days)
Time frame: From Cycle 1 Day 1 (each cycle of 28 days) up to 27.3 months
Time frame: From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months
Time frame: Cycle 1 Day 1 (each cycle of 28 days)
Time frame: Up to 4 hours on Cycle 1 Day 1 (each cycle of 28 days)
Time frame: From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months
Time frame: From Cycle 1 Day 1 (each cycle of 28 days) up to 28.3 months
Janssen Research & Development, LLC
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04988295
Bronchial Neoplasms, Carcinoma, Bronchogenic
Mobile, Alabama, United States
View Trial DetailsNCT06012435
Bronchial Neoplasms, Carcinoma, Bronchogenic
Anchorage, Alaska, United States
View Trial DetailsNCT03485209
Bronchial Neoplasms, Carcinoma
Encinitas, California, United States
View Trial DetailsNCT06447662
Adenocarcinoma, Bronchial Neoplasms
Fayetteville, Arkansas, United States
View Trial Details