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ACTIVE NOT RECRUITING Phase 3

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

Interventions

  • DRUG Lazertinib
  • DRUG Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
  • DRUG Amivantamab Intravenous

Study Locations (20)

California

  • City of Hope Duarte — Duarte
  • City of Hope Orange County Lennar Foundation Cancer Center — Irvine
  • City of Hope Long Beach Elm — Long Beach

Other

  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas) — Buenos Aires
  • Centro Oncológico Korben — Buenos Aires
  • IADT Instituto Argentino de Diagnostico y Tratamiento — CABA

Florida

  • Baptist Lynn Cancer Institute — Boca Raton
  • Orlando Health — Orlando

New Jersey

  • Astera Cancer Care — East Brunswick
  • Rutgers Cancer Institute of New Jersey — New Brunswick

New York

  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center — New York
  • Montefiore Medical Center — The Bronx

Oregon

  • Providence Portland Medical Center — Portland
  • Providence Oncology and Hematology Care Clinic Westside — Portland

Colorado

  • National Jewish Health — Denver

Kansas

  • University of Kansas — Kansas City

Trial Details

FieldValue
Enrollment Target 418 participants
Start Date 2022-08-05
Est. Completion 2027-06-30
Phase Phase 3

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05388669

The ClinicalTrials.gov registry entry for NCT05388669 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 418 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 Advanced or Metastatic Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions — of which Lazertinib 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: NCT05388669 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Other, Florida. 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 NCT05388669 about?

NCT05388669 is a clinical study titled "A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer". The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the p...

What is the current status of trial NCT05388669?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 418 participants. The study started on 2022-08-05. Estimated completion is 2027-06-30.

What conditions does trial NCT05388669 study?

This clinical trial studies the following conditions: Advanced or Metastatic Non-small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05388669?

The interventions under investigation include: Lazertinib (DRUG), Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) (DRUG), Amivantamab Intravenous (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05388669?

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 NCT05388669 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Kansas, Michigan. 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