Interventional Active not recruiting Phase 3
NCT05388669 on ClinicalTrials.gov
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
Official title: A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy
- Sponsor: Janssen Research & Development, LLC
- Enrollment: 418 (Actual)
- Study start: 2022-08-05 (Actual)
- Primary completion: 2024-01-03 (Actual)
- Study completion: 2027-06-30 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Treatment
Brief 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.
Conditions
- Advanced or Metastatic Non-small Cell Lung Cancer
Intervention / Treatment
- Drug: Lazertinib
- Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
- Drug: Amivantamab Intravenous
Primary Outcome Measures
-
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.
Countries
Argentina, Australia, Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Malaysia, Poland, Portugal, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Locations and Investigators
- City of Hope Duarte, Duarte, United States
- City of Hope Orange County Lennar Foundation Cancer Center, Irvine, United States
- City of Hope Long Beach Elm, Long Beach, United States
- National Jewish Health, Denver, United States
- Baptist Lynn Cancer Institute, Boca Raton, United States
- Orlando Health, Orlando, United States
- University of Kansas, Kansas City, United States
- University of Michigan, Ann Arbor, United States
- Astera Cancer Care, East Brunswick, United States
- Rutgers Cancer Institute of New Jersey, New Brunswick, United States
- NYU Langone Health Laura and Isaac Perlmutter Cancer Center, New York, United States
- Montefiore Medical Center, The Bronx, United States
- Providence Portland Medical Center, Portland, United States
- Providence Oncology and Hematology Care Clinic Westside, Portland, United States
- University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine, Philadelphia, United States
- Medical University of South Carolina, Charleston, United States
- Virginia Cancer Specialists, Fairfax, United States
- 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
- CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia, Santo André, Brazil
- Impar Servicos Hospitalares SA Hospital Nove de Julho, São Paulo, Brazil
- Núcleo de Pesquisa São Camilo, São Paulo, Brazil
- Onco Star SP Oncologia Ltda, São Paulo, Brazil
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo, Brazil
- The Ottawa Hospital Cancer Centre, Ottawa, Canada
- Princess Margaret Hospital, Toronto, Canada
- Beijing Shijitan Hospital, Capital Medical University, Beijing, China
- Beijing Friendship Hospital Capital Medical University, Beijing, China
- Peking University Third Hospital, Beijing, China
And 137 other sites.
Study Officials
- Janssen Research & Development, LLC Clinical Trial (Study Director) — Janssen Research & Development, LLC