Premedication to Mitigate Amivantamab Infusion Related Reactions

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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 infusion related reaction (IRR), when amivantamab is given in combination with Lazertinib (by mouth), to reduce first-dose IRRs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Amivantamab-vmjw; Dexamethasone; Lazertinib; Methotrexate; Montelukast

Criteria

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, lazertinib and intravenous (IV) Amivantamab

• Each participant 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

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 dose of study treatment or immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment

• Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed. If brain metastases are diagnosed on Screening imaging, the participant may be enrolled, or rescreened for eligibility, after definitive treatment if above criteria are met

• Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to [<=] 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement therapy)

• Prior treatment with amivantamab or lazertinib contraindications, allergies, hypersensitivity, or intolerance to lazertinib, IV amivantamab, dexamethasone, montelukast, methotrexate or their excipients. Methotrexate is contraindicated in pregnancy, alcoholism or liver disease, immunodeficiency syndromes, preexisting blood dyscrasias, and hypersensitivity to methotrexate