Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Dexamethasone
  • DRUG Montelukast
  • DRUG Methotrexate
  • DRUG Amivantamab
  • DRUG Lazertinib

Study Locations (20)

Other

  • CHU de Brest - Hopital de la Cavale Blanche — Brest
  • Centre Leon Berard — Lyon
  • Hopital Cochin — Paris
  • Hopital Europeen Georges-Pompidou — Paris
  • CHU Rouen Hopital Charles Nicolle — Rouen
  • Nouvel Hopital Civil - CHU Strasbourg — Strasbourg
  • Chungbuk National University Hospital — Cheongju-si
  • National Cancer Center — Gyeonggi-do
  • Gachon University Gil Medical Center — Incheon
  • Chonnam National University Hwasun Hospital — Jeollanam-do
  • Seoul National University Bundang Hospital — Seongnam-si
  • Asan Medical Center — Seoul
  • Hosp. de La Santa Creu I Sant Pau — Barcelona
  • Hosp Univ Vall D Hebron — Barcelona
  • Hosp. Univ. Quiron Dexeus — Barcelona
  • Hosp. San Pedro de Alcantara — Cáceres
  • Hosp. de Jerez de La Frontera — Jerez de la Frontera

California

  • Compassionate Cancer Care — Fountain Valley

Virginia

  • Virginia Cancer Specialists — Fairfax

Washington

  • UW Medicine Valley Medical Center — Renton

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2023-05-18
Est. Completion 2026-07-30
Phase Phase 2

Sponsor

Janssen Research & Development

442 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05663866

The ClinicalTrials.gov registry entry for NCT05663866 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Carcinoma, Non-Small-Cell Lung appearing as the primary indexed condition, and to 5 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05663866 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05663866 about?

NCT05663866 is a clinical study titled "Premedication to Reduce Amivantamab Associated Infusion Related Reactions". 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.

What is the current status of trial NCT05663866?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2023-05-18. Estimated completion is 2026-07-30.

What conditions does trial NCT05663866 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small-Cell Lung. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05663866?

The interventions under investigation include: Dexamethasone (DRUG), Montelukast (DRUG), Methotrexate (DRUG), Amivantamab (DRUG), Lazertinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05663866?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05663866 being conducted?

This trial has 20 study locations across California, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial