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Clinical Trials in the USA / NCT05388669
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 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2022-08-05
Last updated
2026-08-31

Condition(s) studied

Advanced or Metastatic Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

LazertinibAmivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)Amivantamab Intravenous

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started \[US\]) or an accredited local laboratory (sites outside of the US) * Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKI\]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease * Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1 * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 * 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) Exclusion Criteria: * Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors * Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization * Participant has symptomatic or progressive brain metastases * Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation * Participant has uncontrolled tumor-related pain * Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Primary outcome measure(s)

Trial sites (187)

FacilityCityRegionStatus
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.

Official registry record

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 the USA