Dexamethasone: Dexamethasone will be administered orally.
Montelukast: Montelukast will be administered orally.
Methotrexate: Methotrexate will be administered subcutaneously.
Amivantamab: Amivantamab will be administered intravenously.
Lazertinib: Lazertinib tablets will be administered orally.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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
Primary outcome measure(s)
Percentage of Participants With Infusion-related Reactions (IRRs) at Cycle 1 Day 1 — Cycle 1 Day 1 (each cycle of 28 days) Percentage of participants with IRRs at Cycle 1 Day 1 was reported. IRRs were 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. IRR included chills, dyspnea, flushing, nausea, chest discomfort, vomiting, tachycardia, hypotension, and fever. IRRs that occurred on Cycle 1 Day 2 pre-infusion were considered under Cycle 1 Day 1.
Trial sites (36)
Facility
City
Region
Status
Compassionate Cancer Care
Fountain Valley
California
Virginia Cancer Specialists
Fairfax
Virginia
UW Medicine Valley Medical Center
Renton
Washington
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
Hosp. Clinico Univ. de Santiago
Santiago de Compostela
Spain
Inst. Valenciano de Oncologia
Valencia
Spain
Hosp. Gral. Univ. Valencia
Valencia
Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza
Spain
Changhua Christian Hospital
Changhua
Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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