Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05663866
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Dexamethasone will be administered orally.
  • Montelukast — DRUG
    Montelukast will be administered orally.
  • Methotrexate — DRUG
    Methotrexate will be administered subcutaneously.
  • Amivantamab — DRUG
    Amivantamab will be administered intravenously.
  • Lazertinib — DRUG
    Lazertinib tablets will be administered orally.

Study Details

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.

Key Dates

Start date
May 18, 2023
Status verified
Jun 2026
Primary completion
Mar 29, 2024
Completion
Mar 31, 2027

Study Design

Enrollment
68 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
    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.

Primary Outcome Measure

Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1 [ Time Frame: Cycle 1 Day 1 (each cycle of 28 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Compassionate Cancer CareFountain ValleyCalifornia92708-
Virginia Cancer SpecialistsFairfaxVirginia22031-
UW Medicine Valley Medical CenterRentonWashington98055-

Related coverage on Hipa.ai

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