Premedication to Reduce Amivantamab Associated Infusion Related Reactions
NCT ID: NCT05663866
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
68 participants
INTERVENTIONAL
2023-05-18
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Background Anti-cancer Therapy with Amivantamab Plus Lazertinib
Participant will receive following treatments in 4 different cohorts prior to administration of combination therapy of IV Amivantamab and oral Lazertinib (anti-cancer regimen): dexamethasone dose-1 in Cohort A; dexamethasone dose-2 in Cohort A2; montelukast in Cohort B; and methotrexate in Cohort C.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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61186372NSC2005
Identifier Type: OTHER
Identifier Source: secondary_id
2022-000974-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506578-11-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109305
Identifier Type: -
Identifier Source: org_study_id