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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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506578-11-00
Acronym
61186372NSC2005
Enrollment
60
Registered
2024-01-31
Start date
2023-04-25
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer

Brief summary

Rate of IRRs occurring on Cycle 1 Day 1 following administration of oral lazertinib and IV amivantamab combination therapy, which is 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.

Interventions

DRUGDexamethason 4 mg JENAPHARM®
DRUG10mg/ml
DRUGMethotrexate

Sponsors

Janssen - Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Rate of IRRs occurring on Cycle 1 Day 1 following administration of oral lazertinib and IV amivantamab combination therapy, which is 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.

Countries

France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026