At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Dexamethasone, Montelukast, and 3 other interventions for Carcinoma, Non-Small-Cell Lung. Active but no longer recruiting, targeting 68 participants across 36 sites in 5 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.
Interventions
Dexamethasone will be administered orally.
Montelukast will be administered orally.
Methotrexate will be administered subcutaneously.
Amivantamab will be administered intravenously.
Lazertinib tablets will be administered orally.