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
Condition(s) studied
Investigational drug(s) / intervention(s)
Lazertinib: Lazertinib tablets will be administered orally.
Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF): Amivantamab injection will be administered subcutaneously by manual injection.
Amivantamab Intravenous: Amivantamab will be administered by IV infusion.
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.
Eligibility
Primary outcome measure(s)
- For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State — Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration. - For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab — Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
Ctrough was the observed serum concentration of Amivantamab immediately prior to the next drug administration. - Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2 — Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1
AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.
Trial sites (187)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope Duarte | Duarte | California | |
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | |
| City of Hope Long Beach Elm | Long Beach | California | |
| National Jewish Health | Denver | Colorado | |
| Baptist Lynn Cancer Institute | Boca Raton | Florida | |
| Orlando Health | Orlando | Florida | |
| University of Kansas | Kansas City | Kansas | |
| University of Michigan | Ann Arbor | Michigan | |
| Astera Cancer Care | East Brunswick | New Jersey | |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | |
| NYU Langone Health Laura and Isaac Perlmutter Cancer Center | New York | New York | |
| Montefiore Medical Center | The Bronx | New York | |
| Providence Portland Medical Center | Portland | Oregon | |
| Providence Oncology and Hematology Care Clinic Westside | Portland | Oregon | |
| University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | |
| Medical University of South Carolina | Charleston | South Carolina | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| CEMIC (Centro de Educación Médica e Investigaciones Clínicas) | Buenos Aires | Argentina | |
| Centro Oncológico Korben | Buenos Aires | Argentina | |
| IADT Instituto Argentino de Diagnostico y Tratamiento | CABA | Argentina | |
| Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Córdoba | Argentina | |
| Sanatorio Allende | Córdoba | Argentina | |
| Clínica Viedma | Viedma | Argentina | |
| Cancer Research SA | Adelaide | Australia | |
| Chris O'Brien Lifehouse | Camperdown | Australia | |
| Peter MacCallum Cancer Centre | Melbourne | Australia | |
| St John of God Hospital Murdoch | Murdoch | Australia | |
| Westmead Hospital | Westmead | Australia | |
| Princess Alexandra Hospital | Woolloongabba | Australia | |
| Fundacao Pio XII | Barretos | Brazil | |
| Cetus Oncologia | Belo Horizonte | Brazil | |
| Instituto Cionc de Ensino e Pesquisa S/S | Curitiba | Brazil | |
| Ynova Pesquisa Clinica | Florianópolis | Brazil | |
| Fundacao Sao Francisco Xavier HMC Unidade de Oncologia | Ipatinga | Brazil | |
| UPCO Unidade de Pesquisa Clinica em Oncologia | Pelotas | Brazil | |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Porto Alegre | Brazil | |
| Impar Servicos Hospitalares S/A | Rio de Janeiro | Brazil | |
| Oncoclinicas Rio de Janeiro S A | Rio de Janeiro | Brazil | |
| Instituto D Or de Pesquisa e Ensino IDOR | Rio de Janeiro | Brazil | |
| Nucleo de Oncologia da Bahia | Salvador | Brazil |
+ 147 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in South Korea
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05388669 on ClinicalTrials.gov ↗ ← All trials in South Korea