Trial results for the Phase 2 study NCT05663866, investigating premedication to reduce amivantamab-associated infusion-related reactions (IRRs), were posted on ClinicalTrials.gov on 2025-10-20. The study found that dexamethasone 8 mg reduced the percentage of participants experiencing IRRs at Cycle 1 Day 1 to 22.5%.
Background
Amivantamab is a treatment for which infusion-related reactions are a known concern. The study aimed to assess whether specific premedications—dexamethasone, montelukast, or methotrexate—could decrease the incidence and/or severity of first-dose infusion-related reactions when administered prior to amivantamab infusion.
Trial design
The study NCT05663866 was a Phase 2 trial with an enrollment of 68 participants. The trial investigated premedication strategies for patients with Non-Small-Cell Lung Carcinoma receiving amivantamab. Participants were divided into cohorts to evaluate different premedication regimens: dexamethasone 4 mg (Cohort A), dexamethasone 8 mg (Cohort A2), montelukast 10 mg (Cohort B), and methotrexate 25 mg (Cohort C). The primary focus of the study was the "Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1".
Key results
The trial evaluated the "Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1" across different premedication cohorts:
- In Cohort A, participants receiving dexamethasone 4 mg as premedication experienced IRRs at a rate of 83.3%.
- In Cohort A2, participants receiving dexamethasone 8 mg as premedication experienced IRRs at a rate of 22.5%.
- In Cohort B, participants receiving montelukast 10 mg as premedication experienced IRRs at a rate of 66.7%.
- In Cohort C, participants receiving methotrexate 25 mg as premedication experienced IRRs at a rate of 83.3%.
What this means
The results suggest that increasing the dose of dexamethasone from 4 mg to 8 mg as a premedication significantly reduces the incidence of infusion-related reactions associated with amivantamab. The observed reduction from 83.3% with dexamethasone 4 mg to 22.5% with dexamethasone 8 mg indicates a potential strategy to improve patient tolerability for amivantamab infusions. Neither montelukast 10 mg nor methotrexate 25 mg demonstrated a comparable reduction in IRRs in this study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05663866, titled "Premedication to Reduce Amivantamab Associated Infusion Related Reactions," were posted on 2025-10-20 on clinicaltrials.gov.