Premedication to Reduce Amivantamab Associated Infusion Related Reactions (NCT05663866) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
United States, France68 participantsStarted 2023-05-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant must have advanced or metastatic non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
* A female participant using oral contraceptives must use an additional barrier contraceptive method
* A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 3 months after receiving the last dose of study treatment, oral lazertinib and intravenous (IV) Amivantamab
* Each participant, or legally authorized representative, where allowed, must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Progressed on or after prior treatment with osimertinib and platinum-based chemotherapy. Prior use of first-or-second generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) is allowed if administered prior to osimertinib
* Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments \[CLIA\]-certified laboratory \[or equivalent\])
Exclusion Criteria:
* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
* Prior treatment with anti PD-1 or anti PD-L1 antibody within 6 weeks of planned first…
What they're measuring
1
Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1