Clinical trial NCT05388669: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Advanced or Metastatic Non-small Cell Lung Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-05-24
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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 outcomes:
measure: 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 on Cycle 4 Day 1
timeFrame: Cycle 4 Day 1 (28 days cycle)
measure: For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
timeFrame: Cycle 2 Day 1 (28 days cycle)
measure: Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2
timeFrame: Cycle 2 Day 1 to Cycle 2 Day 15 (28 days cycle)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 1 year 11 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 1 year 11 months
measure: Duration of Response (DOR)
timeFrame: Up to 1 year 11 months
measure: Time to Response (TTR)
timeFrame: Up to 1 year 11 months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 4 year 11 months
measure: Number of Participants with AEs by Severity
timeFrame: Up to 4 year 11 months
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to 4 year 11 months
measure: Number of Participants with Clinical Laboratory Abnormalities by Severity
timeFrame: Up to 4 year 11 months
measure: Number of Participants Infusion Related Reactions (IRRs)
timeFrame: Up to 1 year 11 months
measure: Number of Participants with Infusion Related Reactions (IRRs) by Severity
timeFrame: Up to 1 year 11 months
measure: For All Regions Other Than the EU and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
timeFrame: Cycle 2 Day 1 (28 days cycle)
measure: For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
timeFrame: Cycle 4 Day 1 (28 days cycle)
measure: Model-Predicted Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab at Steady State of Cycle 4
timeFrame: From Cycle 4 Day 1 to Cycle 4 Day 15 (28 days cycle)
measure: Percentage of Participants with Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies
timeFrame: Up to 1 year 11 months
measure: Percentage of Participants with Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)
timeFrame: Up to 1 year 11 months
measure: Change from Baseline in TASQ as Assessed Over Time
timeFrame: Up to 1 year 11 months
measure: Participant Chair Time
timeFrame: Up to 1 year 11 months
measure: Duration of Treatment Administration
timeFrame: Up to 1 year 11 months
measure: Active HCP Time For Drug Preparation, Treatment Administration and Posttreatment Monitoring
timeFrame: Up to 1 year 11 months
measure: Participant Time in Treatment Room
timeFrame: Up to 1 year 11 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Duarte
state: California
city: Irvine
country: United States
facility: City of Hope Orange County Lennar Foundation Cancer Center
state: California
city: Long Beach
country: United States
facility: City of Hope Long Beach Elm
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Boca Raton
country: United States
facility: Baptist Lynn Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health Laura and Isaac Perlmutter Cancer Center
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Oncology and Hematology Care Clinic Westside
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Buenos Aires
country: Argentina
facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
city: Caba
country: Argentina
facility: IADT Instituto Argentino de Diagnostico y Tratamiento
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Oncológico Korben
city: Cordoba
country: Argentina
facility: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: Viedma
country: Argentina
facility: Clínica Viedma
city: Adelaide
country: Australia
facility: Cancer Research SA
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: Murdoch
country: Australia
facility: St John of God Hospital Murdoch
city: Westmead
country: Australia
facility: Westmead Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia
city: Curitiba
country: Brazil
facility: Instituto Cionc de Ensino e Pesquisa S/S
city: Florianopolis
country: Brazil
facility: Ynova Pesquisa Clinica
city: Ipatinga
country: Brazil
facility: Fundacao Sao Francisco Xavier HMC Unidade de Oncologia
city: Pelotas
country: Brazil
facility: UPCO Unidade de Pesquisa Clinica em Oncologia
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
city: Rio de Janeiro
country: Brazil
facility: Impar Servicos Hospitalares S/A
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: Rio de Janeiro
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Salvador
country: Brazil
facility: Nucleo de Oncologia da Bahia
city: Santo Andre
country: Brazil
facility: CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
city: Sao Paulo
country: Brazil
facility: Impar Servicos Hospitalares SA Hospital Nove de Julho
city: Sao Paulo
country: Brazil
facility: Onco Star SP Oncologia Ltda
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa São Camilo
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Friendship Hospital Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Chest hospital, Capital medical university
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Changchun
country: China
facility: Jilin cancer hospital
city: Changzhou
country: China
facility: The First People's Hospital Of Changzhou
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: ChongQing
country: China
facility: Southwest Hospital
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
city: Guang Zhou
country: China
facility: The First Affiliated Hospital Sun Yat sen University
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University
city: Hang Zhou
country: China
facility: Zhejiang Cancer Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College of Medicine
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Harbin
country: China
facility: Harbin medical university cancer hospital
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
city: Huizhou
country: China
facility: Huizhou First Hospital
city: Liuzhou
country: China
facility: Liuzhou people's Hospital
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shen Zhen Shi
country: China
facility: Shenzhen People s Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Shenzhen
country: China
facility: Shenzhen university General Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology
city: XI An
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: La Tronche
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: Institute Coeur Poumon
city: Limoges
country: France
facility: CHU de Limoges Hopital Dupuytren
city: Marseille Cedex 20
country: France
facility: Hopital Nord
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Georgsmarienhütte
country: Germany
facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Münster
country: Germany
facility: Munster University Hospital
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
city: Weinsberg
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Bari
country: Italy
facility: Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
city: Bologna
country: Italy
facility: A O U Sant Orsola Malpighi
city: Milano
country: Italy
facility: European Institute of Oncology
city: Orbassano
country: Italy
facility: Aou San Luigi Gonzaga
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - IRCCS
city: Ravenna
country: Italy
facility: Ospedale S. Maria Delle Croci
city: Roma
country: Italy
facility: A.O. San Camillo Forlanini
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Matsusaka
country: Japan
facility: Matsusaka Municipal Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka City
country: Japan
facility: Osaka International Cancer Institute
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Toyonaka-shi
country: Japan
facility: National Hospital Organization Osaka Toneyama Medical Center
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamaguchi
country: Japan
facility: National Hospital Organization Iwakuni Clinical Center
city: Yamaguchi
country: Japan
facility: National Hospital Organization Yamaguchi Ube Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Gyeongsangnam-do
country: Korea, Republic of
facility: GyeongSang National University Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Prince Court Medical Centre
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Petaling Jaya
country: Malaysia
facility: Beacon Hospital Sdn Bhd
city: Petaling Jaya
country: Malaysia
facility: Sunway Medical Centre
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalityczny im. Jana Pawla II
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc
city: Poznan
country: Poland
facility: Private Specialist Hospitals - MedPolonia
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Hospital da Luz, SA
city: Lisboa
country: Portugal
facility: Hosp. Cuf Descobertas
city: Senhora da Hora
country: Portugal
facility: Ulsm - Hosp. Pedro Hispano
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. de Alicante
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp. Univ. Quiron Dexeus
city: Córdoba
country: Spain
facility: Hosp Reina Sofia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hosp. Univ. Insular de Gran Canaria
city: Lugo
country: Spain
facility: Hosp. Univ. Lucus Augusti
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Majadahonda
country: Spain
facility: Hosp. Univ. Pta. de Hierro Majadahonda
city: Málaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Oviedo
country: Spain
facility: Hosp. Univ. Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hosp. Univ. Son Espases
city: Sevilla
country: Spain
facility: Hosp. Virgen Del Rocio
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Kung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Cancer Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital and Medical College
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiangmai
country: Thailand
facility: Chiang Mai University
city: Adana
country: Turkey
facility: Adana City Hospital
city: Adana
country: Turkey
facility: Adana Baskent Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Gazi University Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Acıbadem Maslak Hospital
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Izmir
country: Turkey
facility: IEU Medical Point Hospital
city: Samsun
country: Turkey
facility: Medical Park Samsun Hastanesi
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Freeman Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: