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Активно (без набиране) Фаза 3 NCT04988295

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

Фаза 3 – широко изпитване преди одобрение
Заболявания: Carcinoma, Non-Small-Cell Lung

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.
Кой може да участва
Inclusion Criteria: * Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated * Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation * A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease * Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 * Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade \<= 2 peripheral neuropathy, or Grade \<= 2 hypothyroidism stable on hormone replacement) * A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study * Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8) Exclusion Criteria: * Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization * Participant with symptomatic or progressive brain metastases * Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation * Participant has known small cell transformation * Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis * Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines
Интервенции
Lazertinib
DRUG
Amivantamab
DRUG
Pemetrexed
DRUG
Carboplatin
DRUG
Места на провеждане 249
Argentina (8)
CINME Centro de Investigaciones Metabolicas
Caba
IADT Instituto Argentino de Diagnostico y Tratamiento
CABA
Centro Medico Fleischer
CABA
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
CABA
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba
Hospital Privado Universitario De Cordoba
Córdoba
Hospital Privado de la Comunidad
Mar del Plata
Clínica Viedma
Viedma
Белгия (7)
Grand Hopital De Charleroi Site Les Viviers
Charleroi
UZA
Edegem
UZ Gent
Ghent
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt
UZ Leuven
Leuven
CHU Sart-Tilman
Liège
Clinique Saint Pierre
Ottignies
Бразилия (21)
Cetus Oncologia
Belo Horizonte
CIONC Centro Integrado de Oncologia de Curitiba
Curitiba
Ynova Pesquisa Clinica
Florianópolis
Fundacao Sao Francisco Xavier
Ipatinga
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas
Associacao Hospitalar Moinhos de Vento
Porto Alegre
Hospital Ernesto Dornelles
Porto Alegre
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro
Nucleo de Oncologia da Bahia
Salvador
Hospital Sao Rafael
Salvador
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo
Hospital Paulistano
São Paulo
Hospital Alemao Oswaldo Cruz
São Paulo
Hospital Nove de Julho
São Paulo
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo
Onco Star SP Oncologia Ltda
São Paulo
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
Sorocaba
COT - Centro Oncologico do Triangulo S.A
Uberlândia
България (4)
Multifunctional Hospital for Active Treatment 'Serdika'
Sofia
Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
Sofia
Specialized Hospital for Active Treatment in Oncology
Sofia
UMHAT Sofia Med
Sofia
Канада (3)
Arthur J E Child Comprehensive Cancer Centre
Calgary , Alberta
McGill University Health Centre
Montreal , Quebec
British Columbia Cancer Agency
Vancouver , British Columbia
Китай (33)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Peking University People's Hospital
Beijing
Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II
Beijing
Beijing Cancer Hospital
Beijing
Chinese PLA General Hospital
Beijing
Beijing Chest hospital, Capital medical university
Beijing
Hunan Cancer Hospital Chest Tumor Internal Medicine dept. II
Changsha
Hunan Cancer hospital
Changsha
Sichuan Cancer Hospital
Chengdu
West China Hospital Sichuan University
Chengdu
Chongqing University Cancer Hospital
Chongqing
Southwest Hospital
Chongqing
Daping Hospital Army Characteristic Medical Center
Chongqing
The First Affiliated Hospital Sun Yat sen University
Guangzhou
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
Guangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou
Zhejiang Cancer Hospital
Hangzhou
Harbin medical university cancer hospital
Harbin
Huizhou Municipal Central Hospital
Huizhou
Taizhou Hospital of Zhejiang Province
Linhai
Affiliated Hospital of North Sichuan Medical College
Nanchong
Ruijin Hospital Shanghai Jiao Tong University
Shanghai
Fudan University Shanghai Cancer Center
Shanghai
Shanghai East Hospital
Shanghai
Shenzhen university General Hospital
Shenzhen
Cancer Hospital Chinese Academy of Medical Sciences
Shenzhen
Tianjin Medical University General Hospital
Tianjin
Weifang People's Hospital
Weifang
The First Affiliated Hospital of Xian Jiaotong University
Xi'an
Yantai Yuhuangding Hospital
Yantai
Henan Cancer Hospital
Zhengzhou
Чехия (3)
Fakultni nemocnice Olomouc - I.P.Pavlova 6
Olomouc
Vitkovicka nemocnice a.s.
Ostrava- Vitkovice
Fakultni nemocnice Plzen
Pilsen
Дания (1)
Rigshospitalet
Copenhagen
Франция (13)
Institut Sainte Catherine
Avignon
Hospices Civils de Lyon HCL
Bron
CHU de Grenoble Hopital Albert Michallon
La Tronche
Centre Hospitalier du Mans
Le Mans
CHR Hôpital Calmette
Lille
Hopital Nord
Marseille
CHU de Montpellier - Arnaud de Villeneuve
Montpellier
Institut Curie
Paris
CHU Bordeaux
Pessac
CHRU Hopital de Pontchaillou
Rennes
CHU Nantes
Sain-Herblain
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg
CHU Bretonneau
Tours
Германия (9)
Evangelische Lungenklinik Berlin
Berlin
Asklepios Klinikum Harburg
Hamburg
Thoraxklinik am Universitatsklinikum Heidelberg
Heidelberg
Onkologische Schwerpunktpraxis
Heilbronn
POIS Sachsen GmbH iG
Leipzig
Bethanien Krankenhaus
Moers
Klinikum der Universitaet Muenchen
München
Oncologianova GmbH
Recklinghausen
Universitaetsklinikum Regensburg
Regensburg
Hong Kong (1)
Queen Mary Hospital
Hong Kong
Индия (8)
Health Care Global Enterprises pvt Ltd
Bangalore
Artemis Hospital
Gurugram
Tata Medical Center
Kolkata
Tata Memorial Hospital
Mumbai
HCG Manavta Cancer Centre
Nashik
Rajiv Gandhi Cancer Institute and Research Centre
New Delh
Noble Hospital Pvt Ltd
Pune
Bhaktivedanta Hospital & Research Institute
Thane
Израел (7)
Soroka University Medical Center
Beersheba
Rambam Health Corporation
Haifa
Shaare Zedek Medical Center
Jerusalem
Meir Medical Center
Kfar Saba
Rabin Medical Center
Petah Tikva
Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Италия (7)
CRO IRCCS Istituto Nazionale Tumori
Aviano
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
Istituto Europeo di Oncologia
Milan
Azienda Ospedaliero-Universitaria Di Parma
Parma
Ospedale S. Maria Delle Croci
Ravenna
Istituto Nazionale Tumori Regina Elena
Roma
Policlinico G.B.Rossi
Verona
Япония (15)
National Hospital Organization Shibukawa Medical Center
Gunma
Hyogo Cancer Center
Hyōgo
Kanagawa Cancer Center
Kanagawa
Kobe City Medical Center General Hospital
Kobe
Kurume University Hospital
Kurume
National Hospital Organization Nagoya Medical Center
Nagoya
Niigata Cancer Center Hospital
Niigata
Osaka International Cancer Institute
Osaka
Shizuoka Cancer Center
Shizuoka
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo
The Cancer Institute Hospital of JFCR
Tokyo
Ehime University Hospital
Toon-shi
Wakayama Medical University Hospital
Wakayama
National Hospital Organization Iwakuni Clinical Center
Yamaguchi
National Hospital Organization Yamaguchi Ube Medical Center
Yamaguchi
Malaysia (5)
University Malaya Medical Centre
Kuala Lumpur
Hospital Tengku Ampuan Afzan
Kuantan
Beacon Hospital Sdn Bhd
Petaling Jaya
Subang Jaya Medical Centre
Subang Jaya
Mount Miriam Cancer Hospital
Tanjung Bungah
Mexico (5)
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara
CIMOVA, Morals Vargas Centro de Investigación SC
León
Health Pharma Professional Research
México
Instituto Nacional de Cancerologia
México
Oncologia Integral Satelite
Naucalpan
Нидерландия (3)
VUMC Amsterdam
Amsterdam
Ziekenhuis St Jansdal
Harderwijk
Erasmus MC
Rotterdam
Полша (7)
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz
Uniwersyteckie Centrum Kliniczne
Gdansk
Szpitale Pomorskie Sp z o o
Gdynia
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
Poznan
Private Specialist Hospitals - MedPolonia
Poznan
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw
Португалия (4)
Uls Santa Maria - Hosp. Pulido Valente
Lisbon
Uls Loures Odivelas - Hosp. Loures
Loures
Uls Santo Antonio - Hosp. Santo Antonio
Porto
Instituto Portugues de Oncologia
Porto
Puerto Rico (1)
Pan American Center for Oncology Trials LLC
Rio Piedras
Russia (2)
City Clinical Hospital #1
Nal'chik
Llc, Eurocityclinic
Saint Petersburg
Южна Корея (9)
National Cancer Center
Gyeonggi-do
CHA Bundang Medical Center, CHA University
Gyeonggi-do
Seoul National University Bundang Hospital
Gyeonggi-do
GyeongSang National University Hospital
Gyeongsangnam-do
Korea University Anam Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
The Catholic University of Korea Seoul St Mary s Hospital
Seoul
Испания (17)
Hosp Univ A Coruna
A Coruña
Hosp. de La Santa Creu I Sant Pau
Barcelona
Hosp. Univ. Quiron Dexeus
Barcelona
Hosp Univ Vall D Hebron
Barcelona
Hosp Clinic de Barcelona
Barcelona
Hosp. Univ. Insular de Gran Canaria
Las Palmas de Gran Canaria
Hosp. Gral. Univ. Gregorio Maranon
Madrid
Hosp Univ Fund Jimenez Diaz
Madrid
Hosp. Univ. 12 de Octubre
Madrid
Hosp. Univ. La Paz
Madrid
Hosp Univ Hm Sanchinarro
Madrid
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda
Hosp Regional Univ de Malaga
Málaga
Clinica Univ. de Navarra
Pamplona
Hosp. Virgen Del Rocio
Seville
Hosp. Univ. I Politecni La Fe
Valencia
Hosp. Gral. Univ. Valencia
Valencia
Швеция (5)
Sahlgrenska Universitetssjukhuset
Gothenburg
Linkoping University Hospital
Linköping
Skanes universitetssjukhus
Lund
Norrlands Universitetssjukhus
Umeå
Akademiska Sjukhuset
Uppsala
Taiwan (7)
Changhua Christian Hospital
Changhua
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City
Taipei Medical University Shuang Ho Hospital
New Taipei City
Chung Shan Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Турция (10)
Adana City Hospital
Adana
Memorial Ankara Hastanesi
Ankara
Gazi University Hospital
Ankara
Ankara Bilkent City Hospital
Ankara
Trakya University Medical Faculty
Edirne
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Bakirkoy Training and Research Hospital
Istanbul
Medipol Mega University Hospital
Istanbul
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul
Medical Point
Izmir
Великобритания (6)
Velindre Hospital
Cardiff
Edinburgh Cancer Centre Western General
Edinburgh
UCL Cancer Institute
London
Guys and St Thomas NHS Foundation Trust
London
The Royal Marsden NHS Trust
London
The Christie Nhs Foundation Trust
Manchester
САЩ (28)
University Cancer And Blood Center LLC
Athens , Georgia
University of Vermont Medical Center
Burlington , Vermont
University of Virginia
Charlottesville , Virginia
TriHealth Network
Cincinnati , Ohio
Rocky Mountain Cancer Centers
Colorado Springs , Colorado
Texas Oncology-Medical City Dallas
Dallas , Texas
Texas Oncology Baylor Charles A Sammons Cancer Center
Dallas , Texas
City of Hope
Duarte , California
Astera Cancer Care
East Brunswick , New Jersey
Virginia Cancer Specialists
Fairfax , Virginia
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale , Florida
Nebraska Cancer Specialists
Grand Island , Nebraska
Texas Oncology
Grapevine , Texas
Alliance Cancer Specialists
Horsham , Pennsylvania
Oncology Consultants Texas
Houston , Texas
University of Mississippi Medical Center
Jackson , Mississippi
Texas Oncology - Northeast
Longview , Texas
Cedars Sinai Medical Center
Los Angeles , California
Baptist Cancer Center
Memphis , Tennessee
Southern Cancer Center, PC
Mobile , Alabama
University of California Irvine
Orange , California
University of Pittsburgh Medical Center
Pittsburgh , Pennsylvania
Providence Portland Medical Center
Portland , Oregon
Kaiser Permanente Northwest
Portland , Oregon
NorthWest Medical Specialties, PLLC
Puyallup , Washington
Arizona Oncology Associates
Tucson , Arizona
Compass Oncology
Vancouver , Washington
Blue Ridge Cancer Care
Wytheville , Virginia
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
17.11.2021
Крайна дата
30.11.2027
Регистрационен номер
NCT04988295
Източник
clinicaltrials.gov
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