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Clinical Trials in the USA / NCT05663866
Active, not recruiting Phase 2

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2023-05-18
Last updated
2026-07-31

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

DexamethasoneMontelukastMethotrexateAmivantamabLazertinib

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)

Trial sites (36)

FacilityCityRegionStatus
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 Kaohsiung City Taiwan
Taichung Veterans General Hospital Taichung Taiwan
Chi-Mei Medical Center, Liouying Tainan Taiwan
National Taiwan University Hospital Taipei Taiwan
Taipei Medical University Taipei Taiwan
Taipei Veterans General Hospital Taipei Taiwan

On this site

📄 Singulair (montelukast) drug profile →

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Official registry record

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.

View NCT05663866 on ClinicalTrials.gov ↗ ← All trials in the USA