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NCT05663866Active, not recruitingPhase 2

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
68 (actual)
First submitted
16 Dec 2022
Start date
18 May 2023
Primary completion date
29 Mar 2024
Lead sponsor
Janssen Research & Development, LLC
Diseases
Lung cancer
NCT number
NCT05663866
EU CT number
2023-506578-11-00
EudraCT number
2022-000974-25

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 68
  • From 18 May 2023 to the primary completion date, 29 Mar 2024
  • 25 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Who the study is looking for

  • 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 \[or equivalent\])

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Fundación Instituto Valenciano de Oncología
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ValenciaSpainCompleted
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 15FranceCompleted
CHU De Rouen
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Rouen CedexFranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
National Cancer Center
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Gyeonggi-doSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Changhua Christian Hospital
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ChanghuaTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
Chi Mei Medical Center - Liouying
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Medical University
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Virginia Cancer Specialists
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FairfaxUnited StatesUnknown status
Compassionate Cancer Care
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Fountain ValleyUnited StatesUnknown status
UW Medicine Valley Medical Center
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RentonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.