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MARIPOSA: A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04487080
Collaborator
(none)
1,074
Enrollment
267
Locations
3
Arms
61.6
Anticipated Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Worldwide, lung cancer is the most commonly diagnosed cancer. In NSCLC the most prevalent actionable driver mutations result in the activation of epidermal growth factor receptor (EGFR). Osimertinib and Lazertinib are EGFR tyrosine kinase inhibitors (TKIs). Amivantamab is a novel bispecific antibody that targets the extracellular domain of both EGFR and MET and can inhibit tumor growth driven by EGFR and mesenchymal-epithelial transition (MET) receptors. Lazertinib inhibits primary activating Exon 19dell and Exon 21 L858R substitution EGFR mutations, and the EGFR T790M+ resistance mutation. The hypothesis is that the amivantamab and lazertinib combination (Arm A) will demonstrate superior PFS compared with single-agent osimertinib (Arm B). The study consists of 3 phases: Screening Phase, Treatment Phase and Follow-up Phase. Participants will undergo response evaluation criteria in solid tumors (RECIST 1.1), pharmacokinetics, and safety evaluations (adverse events, laboratory tests, vital sign measurements, physical examinations).

Study Design

Study Type:
Interventional
Actual Enrollment :
1074 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Only Arm B and C will be masked to all (Double-blind).
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Actual Study Start Date :
Sep 30, 2020
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Nov 18, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Arm A (Open-label): Amivantamab and Lazertinib

Participants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (<) 80 kilogram (kg) and 1400 mg for body weight greater than or equal to (>=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80*3) orally once daily.

Drug: Amivantamab
Participants will receive amivantamab intravenously.
Other Names:
  • JNJ-61186372

    • Drug: Lazertinib
    Participants will receive lazertinib tablets orally.
    Other Names:
  • JNJ-73841937 and YH-25448

    		•
    Active Comparator: Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib

    Participants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80*3) orally once daily.

    Drug: Osimertinib
    Participants will receive osimertinib capsules orally.

    Drug: Placebo
    Participants will receive matching placebo orally.
    Experimental: Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib

    Participants will receive lazertinib 240 mg (80*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily.

    Drug: Lazertinib
    Participants will receive lazertinib tablets orally.
    Other Names:
  • JNJ-73841937 and YH-25448

    • Drug: Placebo
    Participants will receive matching placebo orally.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) According to RECIST v1.1 by Blinded Independent Central Review (BICR) [Up to approximately 42 months]

      PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on BICR using response evaluation criteria in solid tumors (RECIST) v1.1.

    Secondary Outcome Measures

    1. Overall Survival (OS) [Up to approximately 60 months (time from the date of randomization until the date of death due to any cause)]

      Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

    2. Objective Response Rate (ORR) [Up to approximately 42 months]

      ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.

    3. Duration of Response (DOR) [Up to approximately 42 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 as determined by the investigator using RECIST v1.1 criteria.

    4. Progression-Free Survival After First Subsequent Therapy (PFS2) [Up to approximately 42 months]

      The 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.

    5. Time to Symptomatic Progression (TTSP) [Up to approximately 42 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.

    6. Intracranial PFS [Up to approximately 42 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.

    7. Incidence and Severity of Adverse Events (AEs) [Up to approximately 60 months]

      Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 30 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent.

    8. Number of Participants with Clinical Laboratory Abnormalities [Up to approximately 60 months]

      Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.

    9. Number of Participants with Vital Signs Abnormalities [Up to approximately 60 months]

      Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported.

    10. Number of Participants with Physical Examination Abnormalities [Up to approximately 60 months]

      Number of participants with physical examination abnormalities will be reported.

    11. Serum Concentration of Amivantamab [Up to approximately 42 months]

      Serum samples will be analyzed to determine concentrations of amivantamab.

    12. Plasma Concentration of Lazertinib [Up to approximately 42 months]

      Plasma samples will be analyzed to determine concentrations of lazertinib.

    13. Number of Participants with Anti-Amivantamab Antibodies [Up to approximately 42 months]

      Number of participants with antibodies to amivantamab will be reported.

    14. Change from Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ) [Baseline Up to approximately 42 months]

      The NSCLC-SAQ contains 7 items that assess cough, pain, dyspnea, fatigue, and poor appetite over a 7-day recall period. Each multi-item scale and individual item will be summarized using count and percent by visit.

    15. Change from Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) [Baseline Up to approximately 42 months]

      EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation

    • The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care

    • Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis)

    • Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level

    • Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy

    Exclusion Criteria:

    • Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease)

    • Participant has an active or past medical history of leptomeningeal disease

    • Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment less than or equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent

    • Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis

    • Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib

    • Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Oncology Associates, PC - HAL Goodyear Arizona United States 85395
    2 Yuma Regional Medical Center Yuma Arizona United States 85364
    3 City of Hope Long Beach Elm Long Beach California United States 90813
    4 University of California, Irvine Orange California United States 92868
    5 Rocky Mountain Cancer Centers Lone Tree Colorado United States 80124
    6 Cancer Specialists of North Florida Jacksonville Florida United States 32256
    7 University Cancer & Blood Center, LLC Athens Georgia United States 30607
    8 East Jefferson General Hospital Metairie Louisiana United States 70006
    9 Maryland Oncology Hematology, PA Columbia Maryland United States 21044
    10 Henry Ford Hospital Detroit Michigan United States 48202
    11 Minnesota Oncology Hematology, P.A. Edina Minnesota United States 55435
    12 Mayo Clinic Rochester Minnesota United States 55905
    13 Washington University School of Medicine Saint Louis Missouri United States 63110
    14 Astera Cancer Care East Brunswick New Jersey United States 08816
    15 Willamette Valley Cancer Institute and Research Center Eugene Oregon United States 97401
    16 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    17 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    18 Texas Oncology P.A. Austin Texas United States 78745
    19 Oncology Consultants - Texas Houston Texas United States 77030
    20 Virginia Cancer Specialists Fairfax Virginia United States 22031
    21 Instituto Alexander Fleming Buenos Aires Argentina C1428ANZ
    22 Centro Oncológico Korben Ciudad Autónoma de Buenos Aires Argentina C1426AGE
    23 Hospital Privado Centro Medico de Cordoba Cordoba Argentina X5016KEH
    24 Centro Oncologico Riojano Integral (Cori) La Rioja Argentina F5300COE
    25 Clínica Viedma Viedma Argentina R8500ACE
    26 Flinders Medical Centre Bedford Park Australia 5042
    27 Austin Hospital Heidelberg Australia 3084
    28 Cabrini Medical Centre Malvern Australia 3144
    29 St John of God Hospital Murdoch Murdoch Australia 6150
    30 Sir Charles Gairdner Hospital Nedlands Australia 6009
    31 Westmead Hospital Westmead Australia 2145
    32 Southern Medical Day Care Centre Wollongong Australia 2500
    33 Princess Alexandra Hospital Woolloongabba Australia 4102
    34 Cliniques Universitaires Saint-Luc Brussel Belgium 1200
    35 Grand Hôpital de Charleroi, site Notre Dame Charleroi Belgium 6000
    36 UZ Leuven Leuven Belgium 3000
    37 Clinique Saint Pierre Ottignies Belgium 1340
    38 Algemeen Ziekenhuis Delta Roeselare Belgium 8800
    39 Fundacao Pio Xii - Hospital De Cancer De Barretos Barretos Brazil 14784-400
    40 Cetus Oncologia Belo Horizonte Brazil 30110-017
    41 Hospital Evangélico de Cachoeiro de Itapemirim Cachoeiro de Itapemirim Brazil 29308020
    42 Ynova Pesquisa Clinica Florianopolis Brazil 88020-210
    43 Hospital de Caridade de Ijui Ijuí Brazil 98700-000
    44 Liga Norte Riograndense Contra O Cancer Natal Brazil 59062-000
    45 UPCO Unidade de Pesquisa Clinica em Oncologia Pelotas Brazil 96020 080
    46 Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil 90020-090
    47 Centro de Pesquisa em Oncologia - PUCRS Porto Alegre Brazil 90610 000
    48 INCA - Instituto Nacional Do Cancer Rio de Janeiro Brazil 20231-050
    49 Oncoclínicas Rio de Janeiro Brazil 22250 905
    50 Instituto D'Or de Pesquisa e Ensino (IDOR) Rio de Janeiro Brazil 22281-100
    51 Fundação Antônio Prudente - A.C. Camargo Cancer Center Sao Paulo Brazil 01509-010
    52 Núcleo de Pesquisa São Camilo Sao Paulo Brazil 04014-002
    53 IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado Sorocaba Brazil 18030-075
    54 Instituto do Cancer do Estado de Sao Paulo ICESP São Paulo Brazil 01246-000
    55 William Osler Health System Brampton Ontario Canada L6R 3J7
    56 Juravinski Cancer Centre Hamilton Ontario Canada L8V 5C2
    57 The Ottawa Hospital Cancer Centre Ottawa Ontario Canada K1H 8L6
    58 McGill University Health Centre Montreal Quebec Canada H4A 3J1
    59 Beijing Friendship Hospital, Capital Medical University Beijing China 100050
    60 Beijing Cancer Hospital Beijing China 100142
    61 Chinese PLA General Hospital Beijing China 100853
    62 Beijing Chest hospital, Capital medical university Beijing China 101199
    63 Jilin cancer hospital Changchun China 130000
    64 Hunan Cancer hospital Changsha China 410013
    65 The First People's Hospital Of Changzhou Changzhou China 213003
    66 Sichuan Cancer Hospital Chengdu China 610041
    67 West China Hospital, Sichuan University Chengdu China 610041
    68 Southwest Hospital ChongQing China 400038
    69 The First Affiliated Hospital, Sun Yat-sen University Guang Zhou China 510080
    70 Sun Yat-Sen Memorial Hospital Sun Yat-sen University Guangzhou China 510120
    71 Zhejiang Cancer Hospital Hang Zhou China 310022
    72 Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou China 310009
    73 The Second Affiliated Hospital of Zhejiang University College of Medicine Hangzhou China 310009
    74 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou China 310016
    75 Harbin medical university cancer hospital Harbin China 150081
    76 Huizhou Municipal Central Hospital Huizhou China 516001
    77 Taizhou Hospital of Zhejiang Province Linhai China 317000
    78 Nantong Tumor Hospital Nantong China 226300
    79 Ruijin Hospital, Shanghai Jiao Tong University Shanghai China 200025
    80 Shanghai Chest Hospital Shanghai China 200030
    81 Fudan University Shanghai Cancer Center Shanghai China 200032
    82 Shanghai East Hospital Shanghai China 200123
    83 Shengjing Hospital of China Medical University Shenyang China 110022
    84 Tianjin Medical University General Hospital Tianjin China 300052
    85 Cancer Hospital of Xinjiang Medical University Urumchi China 830000
    86 The First Affiliated Hospital of Wenzhou Medical University Wenzhou China 325000
    87 TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology Wuhan China 430030
    88 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China 710061
    89 Yantai Yuhuangding Hospital Yantai China 264000
    90 Henan Cancer Hospital Zhengzhou China 450008
    91 Institut Bergonié Bordeaux France 33000
    92 Hospices Civils de Lyon HCL Bron France 69500
    93 CHU de Grenoble - Hôpital Albert Michallon La Tronche France 38700
    94 Institute Coeur Poumon Lille France 59000
    95 CHU de Limoges Limoges France 87000
    96 Hopital Nord Marseille Cedex 20 France 13915
    97 Institut Curie Paris France 75005
    98 Hôpital Tenon Paris France 75970
    99 CHU Bordeaux Pessac France 33604
    100 CHU Nantes Sain-Herblain France 44800
    101 HIA Begin Saint Mande France 94163
    102 CHU Bretonneau Tours France 37000
    103 Institut Gustave Roussy Villejuif Cedex France 94805
    104 Zentralklinik Bad Berka GmbH Bad Berka Germany 99437
    105 Helios Klinikum Emil von Behring GmbH Berlin Germany 14165
    106 Universitaetsklinikum Essen Essen Germany 45147
    107 Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting Gauting Germany 82131
    108 Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH Halle (Saale) Germany 06120
    109 Thoraxklinik am Universitätsklinikum Heidelberg Heidelberg Germany 69126
    110 Onkologische Schwerpunktpraxis Heilbronn Germany 74072
    111 Kliniken der Stadt Koeln gGmbH Koeln Germany 51109
    112 POIS Leipzig GbR Leipzig Germany 04357
    113 Pius-Hospital Oldenburg Oldenburg Germany 26121
    114 Robert-Bosch-Krankenhaus - Klinik Schillerhoehe Stuttgart Germany 70376
    115 Orszagos Koranyi Tbc es Pulmonologiai Intezet Budapest Hungary H-1529
    116 Veszprém Megyei Tudőgyógyintézet Farkasgyepü Hungary 8582
    117 Mátrai Gyógyintézet-Bronchológia Gyöngyös Hungary 3233
    118 Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz Szekesfehervar Hungary 8000
    119 Markusovszky Egyetemi Oktatokorhaz Szombathely Hungary 9700
    120 Tudogyogyintezet Torokbalint Torokbalint Hungary 2045
    121 Basavatarakam Indo-American Hospital Hyderabad India 500034
    122 Tata Medical Center Kolkata India 700160
    123 Tata Memorial Hospital Mumbai India 400012
    124 HCG Manavta Cancer Centre Nasik India 422002
    125 Noble Hospital Pvt Ltd Pune India 411013
    126 Rambam Health Corporation Haifa Israel 3109601
    127 Hadassah Medical Center Jerusalem Israel 9112001
    128 Meir Medical Center Kfar Saba Israel 44281
    129 Rabin Medical Center Petah Tikva Israel 49100
    130 Chaim Sheba Medical Center Ramat Gan Israel 5262100
    131 Tel-Aviv Sourasky Medical Center Tel-Aviv Israel 6423906
    132 Ospedale San Giuseppe Moscati di Avellino Avellino Italy 83100
    133 Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico Catania Italy 95123
    134 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy 47014
    135 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy 20122
    136 IRCCS Ospedale San Raffaele Milano Italy 20132
    137 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy 20133
    138 Istituto Europeo di Oncologia Milano Italy 20141
    139 San Gerardo Hospital Monza Italy 20052
    140 Ospedale Monaldi Napoli Italy 80100
    141 Aou San Luigi Gonzaga Orbassano Italy 10043
    142 Ospedale S. Maria Delle Croci Ravenna Italy 48121
    143 Irccs Gemelli Roma Italy 00168
    144 Istituto Clinico Humanitas Rozzano Italy 20089
    145 Juntendo University Hospital Bunkyo-Ku Japan 113-8431
    146 National Cancer Center Hospital Chuo-Ku Japan 104-0045
    147 National Hospital Organization Kyushu Medical Center Fukuoka Japan 810-8563
    148 National Hospital Organization Himeji Medical Center Himeji Japan 670-8520
    149 Kansai Medical University Hospital Hirakata Japan 573-1191
    150 Kanazawa University Hospital Kanazawa Japan 920-8641
    151 National Cancer Center Hospital East Kashiwa Japan 277-8577
    152 Kurume University Hospital Kurume Japan 830-0011
    153 Matsusaka Municipal Hospital Matsusaka Japan 515-8544
    154 Niigata Cancer Center Hospital Niigata Japan 951-8566
    155 Okayama University Hospital Okayama Japan 700-8558
    156 Kindai University Hospital Osaka-Sayama-shi Japan 589-8511
    157 National Hospital Organization Shibukawa Medical Center Shibukawa Japan 377-0280
    158 The Cancer Institute Hospital of JFCR Tokyo Japan 135-8550
    159 National Hospital Organization Tokyo Medical Center Tokyo Japan 152-8902
    160 Ehime University Hospital Toon-shi Japan 791-0295
    161 National Hospital Organization Osaka Toneyama Medical Center Toyonaka-shi Japan 560-8552
    162 Wakayama Medical University Hospital Wakayama Japan 641-8510
    163 National Hospital Organization Iwakuni Clinical Center Yamaguchi Japan 740-8510
    164 National Hospital Organization Yamaguchi Ube Medical Center Yamaguchi Japan 755-0241
    165 Inje University Haeundae Paik Hospital Busan Korea, Republic of 48108
    166 Chungbuk National University Hospital Cheongju-si Korea, Republic of 28644
    167 Seoul National University Bundang Hospital Gyeonggi-do Korea, Republic of 13620
    168 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    169 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    170 Asan Medical Center Seoul Korea, Republic of 05505
    171 Samsung Medical Center Seoul Korea, Republic of 06351
    172 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    173 Korea University Guro Hospital Seoul Korea, Republic of 8308
    174 Hospital Pulau Pinang George Town Malaysia 10990
    175 Hospital Sultan Ismail Johor Bahru Malaysia 81100
    176 Hospital Kuala Lumpur Kuala Lumpur Malaysia 50586
    177 University Malaya Medical Centre Kuala Lumpur Malaysia 59100
    178 Hospital Tengku Ampuan Afzan Kuantan Malaysia 25100
    179 Beacon Hospital Sdn. Bhd. Petaling Jaya Malaysia 46050
    180 Mexico Centre for Clinical Research, S.A. de C.V. Ciudad de Mexico Mexico 03100
    181 Health Pharma Professional Research Ciudad de Mexico Mexico 03840
    182 Médica Sur Ciudad de Mexico Mexico 14050
    183 Hospital Civil de Guadalajara Fray Antonio Alcalde Guadalajara Mexico 44280
    184 CIMOVA, Morals Vargas Centro de Investigación SC Leon Mexico 37000
    185 Instituto Nacional de Cancerologia Mexico Mexico 14080
    186 i Can Oncology Center Monterrey Mexico 64710
    187 Oncologia Integral Satelite Naucalpan Mexico 53100
    188 Rijnstate Ziekenhuis Arnhem Netherlands 6815 AD
    189 Ziekenhuis St Jansdal Harderwijk Netherlands 3844 DG
    190 UMC Radboud Nijmegen Netherlands 6525AG
    191 Jeroen Bosch Ziekenhuis s-Hertogenbosch Netherlands 5223 GZ
    192 Centrum Onkologii im. Prof. F. Lukaszczyka Bydgoszcz Poland 85-796
    193 Uniwersyteckie Centrum Kliniczne Gdańsk Poland 80-214
    194 Szpitale Pomorskie Sp. z o.o. Gdynia Poland 81-519
    195 Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Olsztyn Poland 10-357
    196 Private Specialist Hospitals - MedPolonia Poznan Poland 60-693
    197 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa Poland 02-781
    198 Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente Lisboa Portugal 1769-001
    199 Centro Hospitalar Universitario do Porto, EPE Porto Portugal 4099-001
    200 Hospital CUF Porto Porto Portugal 4100-180
    201 Instituto Portugues de Oncologia Porto Portugal 4200-072
    202 Pan American Center for Oncology Trials LLC Rio Piedras Puerto Rico 00935
    203 Irkutsk Regional Oncology Dispensary Irkutsk Russian Federation 664035
    204 Moscow City Oncology Hospital № 62 Krasnogorsk Russian Federation 143423
    205 Krasnoyarsk Regional Oncology Dispensary Krasnoyarsk Russian Federation 660133
    206 Leningrad Regional Oncology Dispensary Kuzmolovsky Russian Federation 188663
    207 MCK Moscow Russian Federation 115533
    208 City Clinical Hospital #1 Nalchik Russian Federation 360000
    209 Nizhny Novgorod Regional Oncological Dispensary Nizhniy Novgorod Russian Federation 603000
    210 Omsk Clinical Oncology Dispensary Omsk Russian Federation 664013
    211 Current medical technologies Saint Petersburg Russian Federation 190121
    212 N.N. Petrov Research Institute Of Oncology Saint Petersburg Russian Federation 197758
    213 Oncology Medical Clinics AV Medical group St-Petersburg Russian Federation 196006
    214 Tambov Regional Oncology Clinical Dispansary Tambov Russian Federation 392013
    215 Tomsk Cancer Research Institute Tomsk Russian Federation 634050
    216 Bashkir State Medical University Ufa Russian Federation 450083
    217 Yaroslavl Regional Clinical Oncology Hospital Yaroslavl Russian Federation 150054
    218 Hosp. Univ. A Coruña A Coruña Spain 15006
    219 Inst. Cat. D'Oncologia-Badalona Badalona Spain 08916
    220 Hosp. de La Santa Creu I Sant Pau Barcelona Spain 08025
    221 Hosp. Univ. Quiron Dexeus Barcelona Spain 08028
    222 Hosp. Univ. Vall D Hebron Barcelona Spain 08035
    223 Hosp. Univ. de Burgos Burgos Spain 09006
    224 Institut Català D'Oncologia Girona Girona Spain 17007
    225 Hosp. Gral. Univ. Gregorio Marañon Madrid Spain 28007
    226 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    227 Hosp. Univ. La Paz Madrid Spain 28046
    228 Hosp. Univ. Pta. de Hierro Majadahonda Majadahonda Spain 28222
    229 Hosp. Regional Univ. de Malaga Málaga Spain 29010
    230 Clinica Univ. de Navarra Pamplona Spain 31008
    231 Hosp. Virgen Del Rocio Seville Spain 41013
    232 Hosp. Gral. Univ. Valencia Valencia Spain 46014
    233 Hosp. Clinico Univ. Lozano Blesa Zaragoza Spain 50009
    234 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    235 E-DA Hospital Kaohsiung Taiwan 824
    236 Chang Gung Medical Foundation Kaohsiung Taiwan 833
    237 Taipei Medical University Shuang Ho Hospital New Taipei Taiwan 23561
    238 Chung Shan Medical University Hospital Taichung Taiwan 402
    239 China Medical University Hospital Taichung Taiwan 40447
    240 National Cheng Kung University Hospital Tainan Taiwan 704
    241 National Taiwan University Hospital Taipei City Taiwan 10002
    242 Phramongkutklao Hospital and Medical College Bangkok Thailand 10400
    243 Siriraj Hospital Bangkok Thailand 10700
    244 Chiang Mai University Chiangmai Thailand 50200
    245 Songklanagarind Hospital, Prince of Songkla University Songkla Thailand 90110
    246 Adana City Hospital Adana Turkey 01060
    247 Başkent University Medical Faculty Adana Application and Research Center Adana Turkey 01250
    248 Gazi University Hospital Ankara Turkey 6560
    249 Ankara Bilkent City Hospital Ankara Turkey 6800
    250 Trakya University Medical Faculty Edirne Turkey 22030
    251 Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd Istanbul Turkey 34098
    252 Medipol Mega University Hospital Istanbul Turkey 34214
    253 T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi Istanbul Turkey 34722
    254 Izmir Ekonomi Universitesi Medical Park Hastanesi Izmir Turkey 35580
    255 Necmettin Erbakan University Meram Medical Faculty Konya Turkey 42080
    256 Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 Dnipro Ukraine 49102
    257 Municipal non-profit enterprise 'Regional Center of Oncology' Kharkiv Ukraine 61070
    258 Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies' Kyiv Ukraine 02091
    259 National Cancer Institute Kyiv Ukraine 03022
    260 Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal Uzhgorod Ukraine 88000
    261 Edinburgh Cancer Centre Western General Edinburgh United Kingdom EH4 2XU
    262 UCL Cancer Institute London United Kingdom NW1 2PG
    263 Chelsea And Westminster Hospital London United Kingdom SW10 9NH
    264 The Royal Marsden NHS Trust London United Kingdom SW3 6JJ
    265 Christie NHS Foundation Trust Manchester United Kingdom M20 4BX
    266 Nottingham University Hospitals NHS Trust Nottingham United Kingdom NG5 1PB
    267 The Royal Marsden NHS Trust Sutton United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04487080
    Other Study ID Numbers:
    • CR108856
    • 2020-000743-31
    • 73841937NSC3003
    First Posted:
    Jul 27, 2020
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Osimertinib
    Amivantamab-vmjw
    Lazertinib

    Study Results

    No Results Posted as of Aug 18, 2022