- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 (MARIPOSA-2)
March 26, 2024 updated by: Janssen Research & Development, LLC
A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer.
NSCLC accounts for approximately 85 percent (%) of lung cancers.
Advanced NSCLC is a serious terminal illness that accounts for approximately 20% of all cancer mortality, and until recently had a median overall survival (OS) of approximately 1 year.
Amivantamab (JNJ-61186372) is a low fucose, fully human immunoglobulin (IgG)1-based bispecific antibody directed against EGFR and mesenchymal-epithelial transition (MET) tyrosine kinase receptors.
It shows clinical activity against tumors with primary activating EGFR mutations Exon 19del and Exon 21 L858R substitution.
Lazertinib (JNJ-73841937; YH-25448) is an oral, highly potent, third-generation EGFR tyrosine kinase inhibitor (TKI).
It selectively inhibits both primary activating EGFR mutations (Exon 19del, Exon 21 L858R substitution) and the EGFR T790M resistance mutation, with less inhibition of wild-type EGFR.
The study consists of a Screening Phase (up to 28 days), a Treatment Phase (from randomization until the End of Treatment visit) and a Follow-up Phase (from End of Treatment Visit until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first).
Safety will be assessed by physical examinations, laboratory tests, vital signs, electrocardiograms, Eastern Cooperative Oncology Group (ECOG) performance status, and monitoring of adverse events (AEs).
The total duration of the study is up to 48 months.
Study Type
Interventional
Enrollment (Actual)
776
Phase
- Phase 3
Expanded Access
Approved for sale to the public.
See expanded access record.
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Contact
- Phone Number: 844-434-4210
- Email: Participate-In-This-Study@its.jnj.com
Study Locations
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Caba, Argentina, C1122
- IADT Instituto Argentino de Diagnostico y Tratamiento
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Caba, Argentina, C1414
- Centro Medico Fleischer
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Caba, Argentina, C1431FWO
- CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
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Caba, Argentina, C1027AAP
- CINME Centro de Investigaciones Metabolicas
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Córdoba, Argentina, 5000
- Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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Córdoba, Argentina, X5016KEH
- Hospital Privado Universitario de Cordoba
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Mar del Plata, Argentina, B7602CBM
- Hospital Privado de la Comunidad
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Viedma, Argentina, R8500ACE
- Clinica Viedma
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Charleroi, Belgium, 6000
- Grand Hopital de Charleroi, site Notre Dame
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Edegem, Belgium, 2650
- UZA
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Gent, Belgium, 9000
- UZ Gent
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Hasselt, Belgium, 3500
- Jessa Ziekenhuis - Campus Virga Jesse
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Leuven, Belgium, 3000
- UZ Leuven
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Liege, Belgium, 4000
- CHU Sart-Tilman
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Ottignies, Belgium, 1340
- Clinique Saint Pierre
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Belo Horizonte, Brazil, 30110-017
- Cetus Oncologia
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Curitiba, Brazil, 80810 050
- CIONC Centro Integrado de Oncologia de Curitiba
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Florianopolis, Brazil, 88020-210
- YNOVA Pesquisa Clinica
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Ipatinga, Brazil, 35162 189
- Fundação São Francisco Xavier
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Pelotas, Brazil, 96020 080
- UPCO Unidade de Pesquisa Clinica em Oncologia
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Porto Alegre, Brazil, 90160-093
- Hospital Ernesto Dornelles
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Porto Alegre, Brazil, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Rio de Janeiro, Brazil, 22775-001
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Rio de Janeiro, Brazil, 22250-905
- Oncoclinicas Rio de Janeiro S A
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Rio de Janeiro, Brazil, 22281-100
- Instituto D Or de Pesquisa e Ensino (IDOR)
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Salvador, Brazil, 41253-190
- Hospital Sao Rafael
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Salvador, Brazil, 40170 110
- Núcleo de Oncologia da Bahia
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Santo André, Brazil, 09060-650
- CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
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Sao Paulo, Brazil, 01323-000
- Hospital Paulistano
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Sao Paulo, Brazil, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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Sao Paulo, Brazil, 01327 001
- Hospital Alemao Oswaldo Cruz
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Sao Paulo, Brazil, 01323-900
- Real e Benemérita Associação Portuguesa de Beneficência
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Sorocaba, Brazil, 18030-005
- IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
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São Paulo, Brazil, 01409902
- Hospital Nove de Julho
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São Paulo, Brazil, 04543-000
- Onco Star SP Oncologia Ltda
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Uberlandia, Brazil, 38408-150
- COT - Centro Oncologico do Triangulo S.A
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Sofia, Bulgaria, 1407
- Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
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Sofia, Bulgaria, 1756
- Specialized Hospital for Active Treatment in Oncology
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Sofia, Bulgaria, 1797
- UMHAT Sofia Med
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Sofia, Bulgaria, 1303
- Multifunctional Hospital for Active Treatment 'Serdika'
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre
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Beijing, China, 100142
- Beijing Cancer Hospital
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Beijing, China, 100853
- Chinese PLA General Hospital
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Beijing, China, 100044
- Peking University People's Hospital
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Beijing, China, 100021
- Cancer Hospital, Chinese Academy of Medical Sciences
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Beijing, China, 101199
- Beijing Chest Hospital, Capital Medical University
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Changsha, China, 410013
- Hunan Cancer Hospital
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Chengdu, China, 610041
- Sichuan Cancer Hospital
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Chengdu, China, 610041
- West China Hospital Sichuan University
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ChongQing, China, 400038
- Southwest Hospital
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Chongqing, China, 400000
- Chongqing University Cancer Hospital
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Guang Zhou, China, 510080
- The First Affiliated Hospital, Sun Yat-sen University
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Guangzhou, China, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen University
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Hang Zhou, China, 310022
- Zhejiang Cancer Hospital
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Hangzhou, China, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Hangzhou, China, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Hangzhou, China, 310009
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Harbin, China, 150000
- Harbin Medical University Cancer Hospital
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Huizhou, China, 516001
- Huizhou Municipal Central Hospital
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Linhai, China, 317000
- Taizhou Hospital of Zhejiang Province
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Nanchong, China
- Affiliated Hospital of North Sichuan Medical College
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Shanghai, China, 200025
- Ruijin Hospital, Shanghai Jiao Tong University
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Shanghai, China, 310000
- Shanghai East Hospital
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Shenzhen, China, 518055
- Shenzhen university General Hospital
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Shenzhen, China, 518116
- Cancer Hospital Chinese Academy of Medical Sciences
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Tianjin, China, 300052
- Tianjin Medical University General Hospital
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Weifang, China, 261000
- Weifang People's Hospital
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XI An, China, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Yantai, China, 264000
- Yantai Yuhuangding Hospital
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Yuzhong District, China, 400042
- Daping Hospital Army Characteristic Medical Center
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Zhengzhou, China, 450008
- Henan Cancer Hospital
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Olomouc, Czechia, 775 20
- Fakultni nemocnice Olomouc - I.P.Pavlova 6
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Ostrava- Vitkovice, Czechia, 70300
- Vitkovicka nemocnice a.s.
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Plzen, Czechia, 30599
- Fakultni nemocnice Plzen
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Copenhagen, Denmark, DK-2100
- Rigshospitalet
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Avignon Cedex 9, France, 84918
- Institut Sainte Catherine
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Bron, France, 69500
- Hospices Civils de Lyon HCL
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La Tronche, France, 38700
- CHU de Grenoble Hopital Albert Michallon
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Lille, France, 59000
- CHR Hôpital Calmette
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Marseille Cedex 20, France, 13915
- Hopital Nord
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Montpellier Cedex 5, France, 34295
- CHU de Montpellier - Arnaud de Villeneuve
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Paris, France, 75005
- Institut Curie
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Pessac, France, 33604
- CHU Bordeaux
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Rennes, France, 35033
- CHRU Hopital de Pontchaillou
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Sain-Herblain, France, 44800
- CHU Nantes
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Strasbourg cedex, France, 67091
- Nouvel Hopital Civil - CHU Strasbourg
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Tours, France, 37000
- CHU Bretonneau
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le Mans, France, 72000
- Centre Hospitalier du Mans
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Berlin, Germany, 13125
- Evangelische Lungenklinik Berlin
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Hamburg, Germany, 21075
- Asklepios Klinikum Harburg
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Heidelberg, Germany, 69126
- Thoraxklinik am Universitätsklinikum Heidelberg
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Heilbronn, Germany, 74072
- Onkologische Schwerpunktpraxis
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Leipzig, Germany, 04357
- POIS Sachsen GmbH iG
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Moers, Germany, 47441
- Bethanien Krankenhaus
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München, Germany, 80336
- Klinikum der Universitaet Muenchen
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Recklinghausen, Germany, 45659
- Oncologianova GmbH
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Regensburg, Germany, 93053
- Universitaetsklinikum Regensburg
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Hong Kong, Hong Kong, 999077
- Queen Mary Hospital
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Bangalore, India, 560027
- Health Care Global Enterprises pvt Ltd
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Gurugram, India, 122001
- Artemis Hospital
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Kolkata, India, 700160
- Tata Medical Center
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Mumbai, India, 400012
- Tata Memorial Hospital
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Nasik, India, 422002
- HCG Manavta Cancer Centre
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New Delh, India, 110085
- Rajiv Gandhi Cancer Institute And Research Centre
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Pune, India, 411013
- Noble Hospital Pvt Ltd
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Thane, India, 411107
- Bhaktivedanta Hospital & Research Institute
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Beersheba, Israel, 84101
- Soroka University Medical Center
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Haifa, Israel, 3109601
- Rambam Health Corporation
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Jerusalem, Israel, 91031
- Shaare Zedek Medical Center
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Kfar Saba, Israel, 44281
- Meir Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center
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Ramat Gan, Israel, 5262100
- Chaim Sheba Medical Center
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Tel-Aviv, Israel, 6423906
- Tel-Aviv Sourasky Medical Center
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Aviano, Italy, 33081
- CRO, IRCCS, Istituto Nazionale Tumori
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Meldola, Italy, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milano, Italy, 20141
- Istituto Europeo di Oncologia
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Parma, Italy, 43126
- Azienda Ospedaliero-Universitaria Di Parma
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Ravenna, Italy, 48121
- Ospedale S. Maria Delle Croci
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Roma, Italy, 00144
- Istituto Nazionale Tumori Regina Elena
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Verona, Italy, 37134
- Policlinico G.B.Rossi
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Gunma, Japan, 377-0280
- National Hospital Organization Shibukawa Medical Center
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Hyogo, Japan, 650-0047
- Kobe City Medical Center General Hospital
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Hyogo, Japan, 673-8558
- Hyogo Cancer Center
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Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center
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Kurume, Japan, 830-0011
- Kurume University Hospital
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Nagoya-shi, Japan, 460-0001
- National Hospital Organization Nagoya Medical Center
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Japan, 541-8567
- Osaka International Cancer Institute
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japan, 113-8677
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Tokyo, Japan, 135 8550
- The Cancer Institute Hospital of JFCR
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Toon-shi, Japan, 791-0295
- Ehime University Hospital
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Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
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Yamaguchi, Japan, 740-8510
- National Hospital Organization Iwakuni Clinical Center
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Yamaguchi, Japan, 755-0241
- National Hospital Organization Yamaguchi Ube Medical Center
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Gyeonggi-do, Korea, Republic of, 10408
- National Cancer Center
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Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Korea, Republic of, 13496
- CHA Bundang Medical Center, CHA University
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Gyeongsangnam-do, Korea, Republic of, 52727
- Gyeongsang National University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 02841
- Korea University Anam Hospital
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Seoul, Korea, Republic of, 06591
- The Catholic University of Korea Seoul St. Mary's Hospital
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Kuala Lumpur, Malaysia
- University Malaya Medical Centre
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Kuantan, Malaysia, 25100
- Hospital Tengku Ampuan Afzan
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Petaling Jaya, Malaysia, 46050
- Beacon Hospital Sdn Bhd
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Subang Jaya, Malaysia, 47500
- Subang Jaya Medical Centre
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Tanjung Bungah, Malaysia, 11200
- Mount Miriam Cancer Hospital
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Guadalajara, Mexico, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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Leon, Mexico, 37000
- CIMOVA, Morals Vargas Centro de Investigación SC
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Mexico, Mexico, 03100
- Health Pharma Professional Research
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Mexico, Mexico, 14080
- Instituto Nacional de Cancerologia
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Naucalpan, Mexico, 53100
- Oncologia Integral Satelite
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Amsterdam, Netherlands, 1081 HV
- VUMC Amsterdam
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Harderwijk, Netherlands, 3844 DG
- Ziekenhuis St Jansdal
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Rotterdam, Netherlands, 3015 GD
- Erasmus MC
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Bydgoszcz, Poland, 85-796
- Centrum Onkologii im. Prof. F. Lukaszczyka
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Gdansk, Poland, 80-952
- Uniwersyteckie Centrum Kliniczne
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Gdynia, Poland, 81-519
- Szpitale Pomorskie Sp z o o
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Olsztyn, Poland, 10-357
- Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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Poznan, Poland, 60-693
- Private Specialist Hospitals - MedPolonia
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Poznan, Poland, 60 569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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Warszawa, Poland, 02-781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Lisboa, Portugal, 1769-001
- Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente
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Loures, Portugal, 2674 514
- Hospital Beatriz Angelo
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Porto, Portugal, 4099-001
- Centro Hospitalar Universitario do Porto, EPE
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Porto, Portugal, 4200072
- Instituto Portugues de Oncologia
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Rio Piedras, Puerto Rico, 00917
- Pan American Center for Oncology Trials LLC
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Nalchik, Russian Federation, 360000
- City Clinical Hospital #1
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Saint Petersburg, Russian Federation, 197022
- Llc, Eurocityclinic
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A Coruña, Spain, 15006
- Hosp. Univ. A Coruna
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Barcelona, Spain, 08035
- Hosp. Univ. Vall D Hebron
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Barcelona, Spain, 08025
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Spain, 08028
- Hosp. Univ. Quiron Dexeus
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Barcelona, Spain, 08036
- Hosp. Clinic de Barcelona
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Las Palmas de Gran Canaria, Spain, 35016
- Hosp. Univ. Insular de Gran Canaria
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Madrid, Spain, 28040
- Hosp. Univ. Fund. Jimenez Diaz
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Madrid, Spain, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spain, 28046
- Hosp. Univ. La Paz
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Madrid, Spain, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spain, 28050
- Hosp. Univ. Hm Sanchinarro
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Majadahonda, Spain, 28222
- Hosp. Univ. Pta. de Hierro Majadahonda
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Málaga, Spain, 29010
- Hosp. Regional Univ. de Malaga
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Pamplona, Spain, 31008
- Clinica Univ. de Navarra
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Seville, Spain, 41013
- Hosp. Virgen Del Rocio
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Valencia, Spain, 46014
- Hosp. Gral. Univ. Valencia
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Valencia, Spain, 46026
- Hosp. Univ. I Politecni La Fe
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Goteborg, Sweden, 413 45
- Sahlgrenska Universitetssjukhuset
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Linkoping, Sweden, 581 85
- Linkoping University Hospital
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Lund, Sweden, 221 85
- Skånes universitetssjukhus
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Umea, Sweden, 901 85
- Norrlands Universitetssjukhus
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Uppsala, Sweden, 75181
- Akademiska Sjukhuset
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Changhua, Taiwan, 500
- Changhua Christian Hospital
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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New Taipei City, Taiwan, 23561
- Taipei Medical University Shuang Ho Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taichung, Taiwan, 402
- Chung Shan Medical University Hospital
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Adana, Turkey, 01060
- Adana City Hospital
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Ankara, Turkey, 06520
- Memorial Ankara Hastanesi
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Ankara, Turkey, 06560
- Gazi University Hospital
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Ankara, Turkey, 06800
- Ankara Bilkent City Hospital
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Edirne, Turkey, 22030
- Trakya University Medical Faculty
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Istanbul, Turkey, 34098
- Istanbul University Cerrahpasa Medical Faculty
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Istanbul, Turkey, 34214
- Medipol Mega University Hospital
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Istanbul, Turkey, 34147
- Bakirkoy Training and Research Hospital
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Istanbul, Turkey, 34722
- Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
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Izmir, Turkey, 35575
- Medical Point
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Cardiff, United Kingdom, CF14 2TL
- Velindre Hospital
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Edinburgh, United Kingdom, EH4 2XU
- Edinburgh Cancer Centre Western General
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London, United Kingdom, SE1 9RT
- Guy's and St Thomas' NHS Foundation Trust
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London, United Kingdom, NW1 2PG
- UCL Cancer Institute
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London, United Kingdom, SW3 6JJ
- The Royal Marsden NHS Trust
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Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust
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Alabama
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Mobile, Alabama, United States, 36608
- Southern Cancer Center, PC
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Arizona
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Tucson, Arizona, United States, 85711
- Arizona Oncology Associates
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California
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Duarte, California, United States, 91010
- City of Hope
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
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Orange, California, United States, 92868
- University of California Irvine
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers
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Florida
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Fort Lauderdale, Florida, United States, 33308
- Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
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Georgia
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Athens, Georgia, United States, 30607
- University Cancer & Blood Center, LLC
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Nebraska
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Grand Island, Nebraska, United States, 68803
- Nebraska Cancer Specialists
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New Jersey
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East Brunswick, New Jersey, United States, 08816
- Astera Cancer Care
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Ohio
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Cincinnati, Ohio, United States, 45220
- TriHealth Network
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Oregon
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Portland, Oregon, United States, 97213
- Providence Portland Medical Center
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Portland, Oregon, United States, 97227
- Kaiser Permanente Northwest
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Pennsylvania
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Horsham, Pennsylvania, United States, 19044
- Alliance Cancer Specialists
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Memphis, Tennessee, United States, 38120
- Baptist Cancer Center
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Texas
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Dallas, Texas, United States, 75246
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
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Dallas, Texas, United States, 75230
- Texas Oncology-Medical City Dallas
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Grapevine, Texas, United States, 76051
- Texas Oncology
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Houston, Texas, United States, 77030
- Oncology Consultants - Texas
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Longview, Texas, United States, 75601
- Texas Oncology - Northeast
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Vermont
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Burlington, Vermont, United States, 05401
- University of Vermont Medical Center
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Fairfax, Virginia, United States, 22031
- Virginia Cancer Specialists
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Wytheville, Virginia, United States, 24382
- Blue Ridge Cancer Care
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Washington
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Puyallup, Washington, United States, 98373
- NorthWest Medical Specialties, PLLC
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Vancouver, Washington, United States, 98684
- Compass Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 woman 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm B: CP (Carboplatin and Pemetrexed)
Participants will receive Pemetrexed in combination with Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days).
After 4 cycles, participants will receive Pemetrexed as maintenance until disease progression.
|
Pemetrexed will be administered as an IV infusion.
Carboplatin will be administered as an IV infusion.
|
Experimental: Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)
Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days).
After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.
|
Amivantamab will be administered as an IV infusion.
Other Names:
Pemetrexed will be administered as an IV infusion.
Carboplatin will be administered as an IV infusion.
|
Experimental: Arm A: LACP/ACP-L
LACP dosing (from study start until 6 November 2022): Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin starting on Cycle 1 Day 1 for 4 cycles (each cycle consists of 21 days).
After 4 cycles, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression.
ACP-L dosing (from 7 November 2022 until study completion): Participants will receive Amivantamab, Pemetrexed, and Carboplatin starting on Cycle 1 Day 1 for 4 cycles (each cycle consists of 21 days).
Lazertinib in ACP-L will start on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4 (each cycle consists of 21 days).
Beginning with Cycle 5 Day 1, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression.
|
Lazertinib will be administered orally.
Other Names:
Amivantamab will be administered as an IV infusion.
Other Names:
Pemetrexed will be administered as an IV infusion.
Carboplatin will be administered as an IV infusion.
|
Experimental: Arm A2 (Extension Cohort): ACP-L
Participants will receive Amivantamab and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days), Lazertinib will start on C5D1 or sooner if carboplatin is discontinued earlier).
After 4 cycles, participants will receive Pemetrexed, Amivantamab, Lazertinib as maintenance until disease progression.
|
Lazertinib will be administered orally.
Other Names:
Amivantamab will be administered as an IV infusion.
Other Names:
Pemetrexed will be administered as an IV infusion.
Carboplatin will be administered as an IV infusion.
|
Experimental: Arm C2 (Extension Cohort): ACP
Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days).
After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.
|
Amivantamab will be administered as an IV infusion.
Other Names:
Pemetrexed will be administered as an IV infusion.
Carboplatin will be administered as an IV infusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS) According to RECIST v1.1 Guidelines as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to 17 months
|
PFS is defined as the time from randomization until the date of objective disease progression or death, whichever comes first, using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
|
Up to 17 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Up to 48 months
|
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
|
Up to 48 months
|
Objective Response as Assessed by BICR
Time Frame: Up to 17 months
|
Objective response is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as their best response as defined by BICR using RECIST v1.1 criteria.
|
Up to 17 months
|
Duration of Response (DoR)
Time Frame: Up to 17 months
|
DoR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR.
|
Up to 17 months
|
Time to Subsequent Therapy (TTST)
Time Frame: Up to 17 months
|
TTST is defined as the time from the date of randomization to the start date of the subsequent anti-cancer therapy following study treatment discontinuation, or death whichever comes first.
|
Up to 17 months
|
Progression-Free Survival After First Subsequent Therapy (PFS2)
Time Frame: Up to 17 months
|
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.
|
Up to 17 months
|
Time to Symptomatic Progression (TTSP)
Time Frame: Up to 17 months
|
TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms.
|
Up to 17 months
|
Intracranial PFS
Time Frame: Up to 17 months
|
Intracranial PFS is defined as the time from randomization until the date of objective intracranial disease progression or death, whichever comes first, based on BICR using RECIST v1.1.
|
Up to 17 months
|
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 48 months
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
|
Up to 48 months
|
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Up to 48 months
|
Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urinalysis) will be reported.
|
Up to 48 months
|
Serum Concentration of Amivantamab
Time Frame: Up to 17 months
|
Serum samples will be analyzed to determine concentrations of amivantamab.
|
Up to 17 months
|
Plasma Concentration of Lazertinib
Time Frame: Up to 17 months
|
Plasma samples will be analyzed to determine concentrations of lazertinib.
|
Up to 17 months
|
Number of Participants with Anti-Amivantamab Antibodies
Time Frame: Up to 17 months
|
Number of participants with anti-amivantamab antibodies will be reported.
|
Up to 17 months
|
Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ)
Time Frame: Up to 17 months
|
NSCLC-SAQ is a 7-item PRO measure designed for use in adults to assess symptoms of advanced non-small cell lung cancer (NSCLC).
The NSCLC-SAQ has a seven-day recall period.
It contains five domains and accompanying items that will be identified as symptoms of NSCLC: cough (1 item), pain (2 items), dyspnea (1 item), fatigue (2 items), and appetite (1 item).
Each item uses a response scale between 0 to 4, with higher scores indicating more severe symptomatology.
All five of these domains must be non-missing to compute a total score, with a response range from 0 to 20 with higher scores indicating more severe symptomatology.
|
Up to 17 months
|
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score
Time Frame: Up to 17 months
|
The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items.
The responses are reported using a verbal rating scale.
The item and scale scores are transformed to a 0 to 100 scale.
A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
|
Up to 17 months
|
Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
Time Frame: Up to 17 months
|
PROMIS-PF is used to characterize and better understand overall health, level of physical disability, and general well-being.
Physical function is a foundation for commonly used general and cancer-specific patient reported outcomes (PRO) measures.
|
Up to 17 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2021
Primary Completion (Actual)
July 10, 2023
Study Completion (Estimated)
December 8, 2025
Study Registration Dates
First Submitted
July 30, 2021
First Submitted That Met QC Criteria
July 30, 2021
First Posted (Actual)
August 3, 2021
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- Folic Acid Antagonists
- Carboplatin
- Pemetrexed
- Amivantamab-vmjw
- Lazertinib
Other Study ID Numbers
- CR109061
- 2021-001825-33 (EudraCT Number)
- 61186372NSC3002 (Other Identifier: Janssen Research & Development, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical
trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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