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NCT05388669 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Advanced or Metastatic Non-Small-Cell Lung Cancer, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 418
- Enrollment target
- 20
- Study locations
NCT05388669: Active Phase 3 study of Advanced or Metastatic Non-Small-Cell Lung Cancer, sponsored by Janssen Research & Development.
NCT05388669 is a Phase 3 study of Advanced or Metastatic Non-Small-Cell Lung Cancer that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 418 participants, above the 339-participant average among 3 other Advanced or Metastatic Non-Small-Cell Lung Cancer trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05388669, a Phase 3 study of Advanced or Metastatic Non-Small-Cell Lung Cancer, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 418 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2022-08-05 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
What the registry record for NCT05388669 still lists
NCT05388669 is an interventional study that assigns participants to a tested intervention. The registered 418 participants enrollment target is mid-sized for trials with a published cap, above the 339-participant average among 3 other Advanced or Metastatic Non-Small-Cell Lung Cancer trials with a reported enrollment target (23% higher).
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.
NCT05388669 names 20 study sites across 12 states, led by California, Other, Florida.
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.
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).
Who is sponsoring clinical trial NCT05388669?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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.
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