Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Running, not enrolling · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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 facts

Study ID

NCT05663866

Run by

Janssen Research & Development, LLC

People needed

68

Starts

2023-05-18

Expected to finish

2027-03-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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])

You may not qualify if…

• 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

Where it is running

• Compassionate Cancer Care — Fountain Valley, California, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• UW Medicine Valley Medical Center — Renton, Washington, United States
• CHU de Brest - Hopital de la Cavale Blanche — Brest, France
• Centre Leon Berard — Lyon, France
• Hopital Cochin — Paris, France
• Hopital Europeen Georges-Pompidou — Paris, France
• CHU Rouen Hopital Charles Nicolle — Rouen, France
• Nouvel Hopital Civil - CHU Strasbourg — Strasbourg, France
• Chungbuk National University Hospital — Cheongju-si, South Korea
• National Cancer Center — Gyeonggi-do, South Korea
• Gachon University Gil Medical Center — Incheon, South Korea
• Chonnam National University Hwasun Hospital — Jeollanam-do, South Korea
• Seoul National University Bundang Hospital — Seongnam-si, South Korea
• Asan Medical Center — Seoul, South Korea
• Hosp. de La Santa Creu I Sant Pau — Barcelona, Spain
• Hosp Univ Vall D Hebron — Barcelona, Spain
• Hosp. Univ. Quiron Dexeus — Barcelona, Spain
• Hosp. San Pedro de Alcantara — Cáceres, Spain
• Hosp. de Jerez de La Frontera — Jerez de la Frontera, Spain
• Inst. Cat. Doncologia-H Duran I Reynals — L'Hospitalet de Llobregat, Spain
• Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain
• Hosp. Univ. 12 de Octubre — Madrid, Spain
• Hosp Virgen de La Victoria — Málaga, Spain
• Hosp. Univ. Son Espases — Palma de Mallorca, Spain

Full record on ClinicalTrials.gov

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