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MARIPOSA-2: 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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04988295
Collaborator
(none)
600
Enrollment
304
Locations
3
Arms
48
Anticipated Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy of lazertinib, amivantamab, carboplatin, and pemetrexed (LACP) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP), respectively, 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 17, 2021
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Nov 17, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: LACP (Lazertinib, Amivantamab, Carboplatin, and Pemetrexed)

Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin as intravenous (IV) infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Lazertinib, Pemetrexed, and Amivantamab as maintenance until disease progression.

Drug: Lazertinib
Lazertinib will be administered orally.
Other Names:
  • JNJ-73841937
  • YH-25448

    • Drug: Amivantamab
    Amivantamab will be administered as an IV infusion.
    Other Names:
  • JNJ-61186372

    • Drug: Pemetrexed
    Pemetrexed will be administered as an IV infusion.

    Drug: Carboplatin
    Carboplatin will be administered as an IV infusion.
    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.

    Drug: Pemetrexed
    Pemetrexed will be administered as an IV infusion.

    Drug: Carboplatin
    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.

    Drug: Amivantamab
    Amivantamab will be administered as an IV infusion.
    Other Names:
  • JNJ-61186372

    • Drug: Pemetrexed
    Pemetrexed will be administered as an IV infusion.

    Drug: Carboplatin
    Carboplatin will be administered as an IV infusion.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) According to RECIST v1.1 Guidelines as Assessed by Blinded Independent Central Review (BICR) [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.

    Secondary Outcome Measures

    1. Objective Response as Assessed by BICR [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.

    2. Overall Survival (OS) [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.

    3. Duration of Response (DoR) [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.

    4. Time to Subsequent Therapy (TTST) [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.

    5. Progression-Free Survival After First Subsequent Therapy (PFS2) [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.

    6. Time to Symptomatic Progression (TTSP) [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.

    7. Intracranial PFS [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.

    8. Number of Participants with Adverse Events (AEs) [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.

    9. Number of Participants with Clinical Laboratory Abnormalities [Up to 48 months]

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

    10. Serum Concentration of Amivantamab [Up to 17 months]

      Serum samples will be analyzed to determine concentrations of amivantamab.

    11. Plasma Concentration of Lazertinib [Up to 17 months]

      Plasma samples will be analyzed to determine concentrations of lazertinib.

    12. Number of Participants with Anti-Amivantamab Antibodies [Up to 17 months]

      Number of participants with anti-amivantamab antibodies will be reported.

    13. Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ) [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.

    14. European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Score [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.

    15. Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) [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.

    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Carl T. Hayden Veterans Administration Medical Center Phoenix Arizona United States 85012
    2 City of Hope Duarte California United States 91010
    3 University Of California San Diego La Jolla California United States 92037
    4 Pacific Shores Medical Group in Long Beach Long Beach California United States 90813
    5 Cedars-Sinai Medical Center Los Angeles California United States 90048
    6 University of California, Irvine Orange California United States 92868
    7 St Joseph Heritage Healthcare Santa Rosa California United States 95403
    8 Yale Cancer Center New Haven Connecticut United States 06510
    9 Hartford Hospital Plainville Connecticut United States 06062
    10 University of Miami/Sylvester Cancer Center Aventura Florida United States 33180
    11 Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center Fort Lauderdale Florida United States 33308
    12 University of Florida Gainesville Florida United States 32610
    13 Mayo Clinic Jacksonville Florida United States 32224
    14 University Cancer & Blood Center, LLC Athens Georgia United States 30607
    15 Pacific Health Research and Education Institute Honolulu Hawaii United States 96819
    16 Sinai Cancer Care Chicago Illinois United States 60608
    17 Cancer Care Specialists of Central Illinois Decatur Illinois United States 62526
    18 Indiana University Indianapolis Indiana United States 46202
    19 East Jefferson General Hospital Metairie Louisiana United States 70006
    20 Henry Ford Hospital Detroit Michigan United States 48202
    21 Mayo Clinic Rochester Minnesota United States 55905
    22 University of Mississippi Medical Center Jackson Mississippi United States 39216
    23 Saint Louis University Saint Louis Missouri United States 63110
    24 Nebraska Cancer Specialists Grand Island Nebraska United States 68803
    25 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169
    26 VA Sierra Nevada Health Care System Reno Nevada United States 89502
    27 Astera Cancer Care East Brunswick New Jersey United States 08816
    28 North Shore-Long Island Jewish Health System Lake Success New York United States 11042
    29 Icahn School of Medicine at Mt. Sinai New York New York United States 10029
    30 TriHealth Network Cincinnati Ohio United States 45220
    31 Oklahoma Cancer Specialists and Research Institute, LLC Tulsa Oklahoma United States 74146
    32 Providence Portland Medical Center Portland Oregon United States 97213
    33 Kaiser Permanente Northwest Portland Oregon United States 97227
    34 Alliance Cancer Specialists Horsham Pennsylvania United States 19044
    35 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    36 MUSC-Hollings Cancer Center Charleston South Carolina United States 29425
    37 Sanford Health Sioux Falls South Dakota United States 57117
    38 University of Tennessee Health Sciences Center Memphis Tennessee United States 38103
    39 Baptist Cancer Center Memphis Tennessee United States 38120
    40 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    41 Texas Oncology-Medical City Dallas Dallas Texas United States 75230
    42 Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    43 UT Southwestern Medical Center Dallas Texas United States 75390
    44 Oncology Consultants - Texas Houston Texas United States 77030
    45 UT MD Anderson Cancer Center Houston Texas United States 77030
    46 University of Vermont Medical Center Burlington Vermont United States 05401
    47 University of Virginia Charlottesville Virginia United States 22908
    48 Virginia Cancer Specialists Fairfax Virginia United States 22031
    49 Blue Ridge Cancer Care Wytheville Virginia United States 24382
    50 NorthWest Medical Specialties, PLLC Puyallup Washington United States 98373
    51 IADT Instituto Argentino de Diagnostico y Tratamiento Caba Argentina C1122
    52 Centro Medico Fleischer Caba Argentina C1414
    53 CEMIC (Centro de Educación Médica e Investigaciones Clínicas) Caba Argentina C1431FWO
    54 CINME - Centro de Investigaciones Metabolicas Ciudad Autonoma de Buenos Aires Argentina C1027AAP
    55 Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Córdoba Argentina 5000
    56 Hospital Privado Universitario de Córdoba Córdoba Argentina X5016KEH
    57 Hospital Privado de la Comunidad Mar del Plata Argentina B7602CBM
    58 Centro de Investigaciones Clinicas-CIC-IESR Rosario Argentina 2000
    59 Clínica Viedma Viedma Argentina R8500ACE
    60 Grand Hôpital de Charleroi, site Notre Dame Charleroi Belgium 6000
    61 UZA Edegem Belgium 2650
    62 UZ Gent Gent Belgium 9000
    63 Jessa Ziekenhuis - Campus Virga Jesse Hasselt Belgium 3500
    64 UZ Leuven Leuven Belgium 3000
    65 CHU Sart-Tilman Liege Belgium 4000
    66 Clinique Saint Pierre Ottignies Belgium 1340
    67 Cetus Oncologia Belo Horizonte Brazil 30110-017
    68 CIONC - Centro Integrado de Oncologia de Curitiba Curitiba Brazil 80810-050
    69 Ynova Pesquisa Clinica Florianopolis Brazil 88020-210
    70 Fundação São Francisco Xavier Ipatinga Brazil 35162 189
    71 UPCO Unidade de Pesquisa Clinica em Oncologia Pelotas Brazil 96020 080
    72 Hospital Moinhos de Vento Porto Alegre Brazil 90035-901
    73 Hospital Ernesto Dornelles Porto Alegre Brazil 90160-093
    74 Oncoclínicas Rio de Janeiro Brazil 22250-905
    75 Instituto D'Or de Pesquisa e Ensino (IDOR) Rio de Janeiro Brazil 22281-100
    76 Instituto COI Rio de Janeiro Brazil 22793080
    77 Núcleo de Oncologia da Bahia Salvador Brazil 40170-110
    78 Hospital Sao Rafael Salvador Brazil 41253-190
    79 CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia Santo André Brazil 09060-650
    80 Fundação Antônio Prudente - A.C. Camargo Cancer Center Sao Paulo Brazil 01509-010
    81 IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado Sorocaba Brazil 18030-005
    82 Hospital Paulistano São Paulo Brazil 01323-000
    83 BP - Beneficencia Portuguesa de São Paulo São Paulo Brazil 01323-001
    84 Hospital Alemão Oswaldo Cruz São Paulo Brazil 01327-001
    85 Hospital Nove de Julho São Paulo Brazil 01409902
    86 Onco Star SP Oncologia Ltda São Paulo Brazil 04543-000
    87 Oncoclínicas Uberlândia Brazil 38408-150
    88 Multifunctional Hospital for Active Treatment 'Serdika' Sofia Bulgaria 1303
    89 Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia' Sofia Bulgaria 1407
    90 Specialized Hospital for Active Treatment in Oncology Sofia Bulgaria 1756
    91 UMHAT Sofia Med Sofia Bulgaria 1797
    92 Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD Varna Bulgaria 9010
    93 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    94 British Columbia Cancer Agency Vancouver British Columbia Canada V5Z 4E6
    95 Princess Margaret Cancer Centre University Health Network Toronto Ontario Canada M5G 1Z5
    96 McGill University Health Centre Montreal Quebec Canada H4A 3J1
    97 Cancer Hospital, Chinese Academy of Medical Sciences Beijing China 100021
    98 Peking University People's Hospital Beijing China 100044
    99 Beijing Cancer Hospital Beijing China 100142
    100 Chinese PLA General Hospital Beijing China 100853
    101 Beijing Chest hospital, Capital medical university Beijing China 101199
    102 Hunan Cancer hospital Changsha China 410013
    103 The First People's Hospital Of Changzhou Changzhou China 213003
    104 Sichuan Cancer Hospital Chengdu China 610041
    105 West China Hospital, Sichuan University Chengdu China 610041
    106 Southwest Hospital ChongQing China 400038
    107 Chongqing University Cancer Hospital Chongqing China
    108 The First Affiliated Hospital, Sun Yat-sen University Guang Zhou China 510080
    109 Sun Yat-Sen Memorial Hospital Sun Yat-sen University Guangzhou China 510120
    110 Zhejiang Cancer Hospital Hang Zhou China 310022
    111 Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou China 310009
    112 The Second Affiliated Hospital of Zhejiang University College of Medicine Hangzhou China 310009
    113 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou China 310016
    114 Harbin medical university cancer hospital Harbin China 150000
    115 The First Affiliated hospital of Anliui Medical University Hefei China 230022
    116 Huizhou Municipal Central Hospital Huizhou China 516001
    117 Taizhou Hospital of Zhejiang Province Linhai China 317000
    118 Affiliated Hospital of North Sichuan Medical College Nanchong China
    119 Ruijin Hospital, Shanghai Jiao Tong University Shanghai China 200025
    120 Fudan University Shanghai Cancer Center Shanghai China 200032
    121 Shanghai East Hospital Shanghai China 310000
    122 Shenzhen university General Hospital Shenzhen China 518055
    123 Cancer Hospital Chinese Academy of Medical Sciences Shenzhen China 518116
    124 Tianjin Medical University General Hospital Tianjin China 300052
    125 Weifang People's Hospital Weifang China 261000
    126 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China 710061
    127 Yantai Yuhuangding Hospital Yantai China 264000
    128 Daping Hospital Army Characteristic Medical Center Yuzhong District China 400042
    129 Henan Cancer Hospital Zhengzhou China 450008
    130 Fakultni nemocnice Olomouc - I.P.Pavlova 6 Olomouc Czechia 775 20
    131 Vitkovicka nemocnice a.s. Ostrava- Vitkovice Czechia 70300
    132 Fakultni nemocnice Plzen Plzen Czechia 30599
    133 Aarhus Universitetshospital Aarhus Denmark DK-8200
    134 Rigshospitalet Copenhagen Denmark DK-2100
    135 Institut Sainte Catherine Avignon Cedex 9 France 84918
    136 Hospices Civils de Lyon HCL Bron France 69500
    137 CHU de Grenoble - Hôpital Albert Michallon La Tronche France 38700
    138 Centre Hospitalier Le Mans le mans Cedex 9 France 72037
    139 CHR Hôpital Calmette Lille France 59000
    140 Hopital Nord Marseille Cedex 20 France 13915
    141 CHU de Montpellier - Arnaud de Villeneuve Montpellier Cedex 5 France 34295
    142 Institut Curie Paris France 75005
    143 CHU Bordeaux Pessac France 33604
    144 CHRU Hôpital de Pontchaillou Rennes France 35033
    145 CHU Nantes Sain-Herblain France 44800
    146 Nouvel Hopital Civil - CHU Strasbourg Strasbourg cedex France 67091
    147 CHU Bretonneau Tours France 37000
    148 Evangelische Lungenklinik Berlin Berlin Germany 13125
    149 Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main Germany 60590
    150 Asklepios Klinikum Harburg Hamburg Germany 21075
    151 Thoraxklinik am Universitätsklinikum Heidelberg Heidelberg Germany 69126
    152 Onkologische Schwerpunktpraxis Heilbronn Germany 74072
    153 ViDia Christliche Kliniken Karlsruhe/St. Vincentius-Kliniken Karlsruhe Germany 76135
    154 POIS Sachsen GmbH iG Leipzig Germany 04357
    155 Bethanien Krankenhaus Moers Germany 47441
    156 Klinikum der Universität München München Germany 80336
    157 Pius-Hospital Oldenburg Oldenburg Germany 26121
    158 Oncologianova GmbH Recklinghausen Germany 45659
    159 Universitaetsklinikum Regensburg Regensburg Germany 93053
    160 Queen Mary Hospital Hong Kong Hong Kong 999077
    161 Health Care Global Enterprises pvt Ltd Bangalore India 560027
    162 Artemis Hospital Gurugram India 122001
    163 Tata Medical Center Kolkata India 700160
    164 Tata Memorial Hospital Mumbai India 400012
    165 Kokilaben Dhirubhai Ambani Hosp. & Med. Research Inst Mumbai India 400053
    166 Central India Cancer Research Institute Nagpur India 440010
    167 HCG Manavta Cancer Centre Nasik India 422002
    168 Action Cancer Hospital New Delhi India 110063
    169 Rajiv Gandhi Cancer Institute and Research Centre New Delh India 110085
    170 Noble Hospital Pvt Ltd Pune India 411013
    171 Bhaktivedanta Hospital & Research Institute Thane India 411107
    172 Soroka University Medical Center Beersheba Israel 84101
    173 Rambam Health Corporation Haifa Israel 3109601
    174 Shaare Zedek Medical Center Jerusalem Israel 91031
    175 Meir Medical Center Kfar Saba Israel 44281
    176 Rabin Medical Center Petah Tikva Israel 49100
    177 Chaim Sheba Medical Center Ramat Gan Israel 5262100
    178 Tel-Aviv Sourasky Medical Center Tel-Aviv Israel 6423906
    179 CRO, IRCCS, Istituto Nazionale Tumori Aviano Italy 33081
    180 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy 47014
    181 Istituto Europeo di Oncologia Milano Italy 20141
    182 Azienda Ospedaliero-Universitaria Di Parma Parma Italy 43126
    183 Ospedale S. Maria Delle Croci Ravenna Italy 48121
    184 Istituto Nazionale Tumori Regina Elena Roma Italy 00144
    185 Policlinico G.B.Rossi Verona Italy 37134
    186 National Hospital Organization Shibukawa Medical Center Gunma Japan 377-0280
    187 Kobe City Medical Center General Hospital Hyogo Japan 650-0047
    188 Hyogo Cancer Center Hyogo Japan 673-8558
    189 Kanagawa Cancer Center Kanagawa Japan 241-8515
    190 Kurume University Hospital Kurume Japan 830-0011
    191 National Hospital Organization Nagoya Medical Center Nagoya-shi Japan 460-0001
    192 Niigata Cancer Center Hospital Niigata Japan 951-8566
    193 Osaka International Cancer Institute Osaka Japan 541-8567
    194 Shizuoka Cancer Center Shizuoka Japan 411-8777
    195 Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo Japan 113-8677
    196 The Cancer Institute Hospital of JFCR Tokyo Japan 135-8550
    197 Ehime University Hospital Toon-shi Japan 791-0295
    198 Wakayama Medical University Hospital Wakayama Japan 641-8510
    199 National Hospital Organization Iwakuni Clinical Center Yamaguchi Japan 740-8510
    200 National Hospital Organization Yamaguchi Ube Medical Center Yamaguchi Japan 755-0241
    201 National Cancer Center Gyeonggi-do Korea, Republic of 10408
    202 CHA Bundang Medical Center, CHA University Gyeonggi-do Korea, Republic of 13496
    203 Seoul National University Bundang Hospital Gyeonggi-do Korea, Republic of 13620
    204 GyeongSang National University Hospital Gyeongsangnam-do Korea, Republic of 52727
    205 Korea University Anam Hospital Seoul Korea, Republic of 02841
    206 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    207 Asan Medical Center Seoul Korea, Republic of 05505
    208 Samsung Medical Center Seoul Korea, Republic of 06351
    209 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    210 University Malaya Medical Centre Kuala Lumpur Malaysia
    211 Hospital Tengku Ampuan Afzan Kuantan Malaysia 25100
    212 Beacon Hospital Sdn. Bhd. Petaling Jaya Malaysia 46050
    213 Subang Jaya Medical Centre Subang Jaya Malaysia 47500
    214 Mount Miriam Cancer Hospital Tanjung Bungah Malaysia 11200
    215 Hospital Civil de Guadalajara Fray Antonio Alcalde Guadalajara Mexico 44280
    216 CIMOVA, Morals Vargas Centro de Investigación SC Leon Mexico 37000
    217 Health Pharma Professional Research Mexico Mexico 03100
    218 Instituto Nacional de Cancerologia Mexico Mexico 14080
    219 Oncologia Integral Satelite Naucalpan Mexico 53100
    220 NKI-AVL, Amsterdam Amsterdam Netherlands 1066 CX
    221 VUMC Amsterdam Amsterdam Netherlands 1081 HV
    222 Ziekenhuis St Jansdal Harderwijk Netherlands 3844 DG
    223 Erasmus MC Rotterdam Netherlands 3015 GD
    224 Centrum Onkologii im. Prof. F. Lukaszczyka Bydgoszcz Poland 85-796
    225 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-952
    226 Szpitale Pomorskie Sp. z o.o. Gdynia Poland 81-519
    227 Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Olsztyn Poland 10-357
    228 Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow Poznan Poland 60-569
    229 Private Specialist Hospitals - MedPolonia Poznan Poland 60-693
    230 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa Poland 02-781
    231 Dolnoslaskie Centrum Onkologii Wroclaw Poland 53-439
    232 Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente Lisboa Portugal 1769-001
    233 Hospital Beatriz Angelo Loures Portugal 2674-514
    234 Centro Hospitalar Universitario do Porto, EPE Porto Portugal 4099-001
    235 Instituto Portugues de Oncologia Porto Portugal 4200072
    236 Pan American Center for Oncology Trials LLC Rio Piedras Puerto Rico 00917
    237 Krasnoyarsk Regional Oncology Dispensary Krasnoyarsk Russian Federation 660133
    238 LLC VitaMed Moscow Russian Federation 121309
    239 Central Clinical Hospital Moscow Russian Federation 121359
    240 Main Administration for Service to the Diplomatic Corps under the MoFA of the RF Moscow Russian Federation 125284
    241 Moscow City Oncology Hospital № 62 Moskovskaya Oblast', Krasnogo Russian Federation 143423
    242 City Clinical Hospital #1 Nalchik Russian Federation 360000
    243 Nizhny Novgorod Regional Oncological Dispensary Nizhniy Novgorod Russian Federation 603000
    244 Omsk Clinical Oncology Dispensary Omsk Russian Federation 664013
    245 Llc, Eurocityclinic Saint Petersburg Russian Federation 197022
    246 N.N. Petrov Research Institute Of Oncology Saint Petersburg Russian Federation 197758
    247 Oncology Medical Clinics AV Medical group St-Petersburg Russian Federation 196006
    248 Tambov Regional Oncology Clinical Dispansary Tambov Russian Federation 392013
    249 Tomsk Cancer Research Institute Tomsk Russian Federation 634050
    250 Multifunctional clinical medical center 'Medical city' Tyumen Russian Federation 625041
    251 Bashkir State Medical University Ufa Russian Federation 450083
    252 Hosp. Univ. A Coruña A Coruña Spain 15006
    253 Hosp. de La Santa Creu I Sant Pau Barcelona Spain 08025
    254 Hosp. Univ. Quiron Dexeus Barcelona Spain 08028
    255 Hosp. Univ. Vall D Hebron Barcelona Spain 08035
    256 Hosp. Clinic I Provincial de Barcelona Barcelona Spain 08036
    257 Hosp. Univ. Insular de Gran Canaria Las Palmas de Gran Canaria Spain 35016
    258 Hosp. Gral. Univ. Gregorio Marañon Madrid Spain 28007
    259 Hosp. Univ. Fund. Jimenez Diaz Madrid Spain 28040
    260 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    261 Hosp. Univ. La Paz Madrid Spain 28046
    262 Hosp. Univ. Hm Sanchinarro Madrid Spain 28050
    263 Hosp. Univ. Pta. de Hierro Majadahonda Majadahonda Spain 28222
    264 Hosp. Regional Univ. de Malaga Málaga Spain 29010
    265 Clinica Univ. de Navarra Pamplona Spain 31008
    266 Hosp. Virgen Del Rocio Seville Spain 41013
    267 Hosp. Gral. Univ. Valencia Valencia Spain 46014
    268 Hosp. Univ. I Politecni La Fe Valencia Spain 46026
    269 Sahlgrenska Universitetssjukhuset Goteborg Sweden 413 45
    270 Linkoping University Hospital Linkoping Sweden 581 85
    271 Skanes universitetssjukhus Lund Sweden 221 85
    272 Norrlands Universitetssjukhus Umea Sweden 901 85
    273 Akademiska Sjukhuset Uppsala Sweden 75181
    274 Changhua Christian Hospital Changhua Taiwan 500
    275 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    276 Taipei Medical University Shuang Ho Hospital New Taipei City Taiwan 23561
    277 Chung Shan Medical University Hospital Taichung Taiwan 402
    278 Taichung Veterans General Hospital Taichung Taiwan 40705
    279 National Cheng Kung University Hospital Tainan Taiwan 704
    280 National Taiwan University Hospital Taipei Taiwan 100
    281 Adana City Hospital Adana Turkey 01060
    282 Memorial Ankara Hastanesi Ankara Turkey 06520
    283 Gazi University Hospital Ankara Turkey 06560
    284 Ankara Bilkent City Hospital Ankara Turkey 06590
    285 Trakya University Medical Faculty Edirne Turkey 22030
    286 Istanbul University Cerrahpasa Medical Faculty Istanbul Turkey 34098
    287 Bakirkoy Training and Research Hospital Istanbul Turkey 34147
    288 Medipol Mega University Hospital Istanbul Turkey 34214
    289 Acıbadem Maslak Hospital Istanbul Turkey 34457
    290 Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Istanbul Turkey 34722
    291 Izmir Medical Park Hospital Izmir Turkey 35575
    292 Queen Elizabeth Hospital Birmingham United Kingdom B15 2WG
    293 Birmingham Heartlands Hospital Birmingham United Kingdom B9 5SS
    294 Velindre Hospital Cardiff United Kingdom CF14 2TL
    295 Edinburgh Cancer Centre Western General Edinburgh United Kingdom EH4 2XU
    296 Royal Surrey County Hospital NHS Trust Guildford United Kingdom GU2 7XX
    297 Rutherford Cancer Centre North West Liverpool United Kingdom L7 3EW
    298 Barts Heart Centre, St. Bartholomew's Hospital London United Kingdom EC1A 7BE
    299 UCL Cancer Institute London United Kingdom NW1 2PG
    300 Guy's and St Thomas' NHS Foundation Trust London United Kingdom SE1 9RT
    301 The Royal Marsden NHS Trust London United Kingdom SW3 6JJ
    302 The Christie Nhs Foundation Trust Manchester United Kingdom M20 4BX
    303 Rutherford Cancer Centre South Wales Newport United Kingdom NP10 8FZ
    304 Rutherford Cancer Centre Thames Valley Reading United Kingdom RG2 9LH

    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:
    NCT04988295
    Other Study ID Numbers:
    • CR109061
    • 2021-001825-33
    • 61186372NSC3002
    First Posted:
    Aug 3, 2021
    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
    Carboplatin
    Pemetrexed
    Amivantamab-vmjw
    Lazertinib

    Study Results

    No Results Posted as of Aug 18, 2022