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LIBRETTO-431: A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04194944
Collaborator
Eli Lilly and Company (Industry)
250
Enrollment
206
Locations
3
Arms
66
Anticipated Duration (Months)
1.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Actual Study Start Date :
Feb 17, 2020
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Aug 18, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Selpercatinib

Selpercatinib administered orally.

Drug: Selpercatinib
Administered orally
Other Names:
  • LY3527723
  • LOXO-292

    		•
    Active Comparator: Pemetrexed with or without Pembrolizumab

    Pemetrexed administered intravenously (IV) plus the investigator's discretion of carboplatin IV or cisplatin IV with or without pembrolizumab IV.

    Drug: Carboplatin
    Administered IV

    Drug: Cisplatin
    Administered IV

    Drug: Pemetrexed
    Administered IV

    Drug: Pembrolizumab
    Administered IV
    Active Comparator: Pemetrexed with Pembrolizumab

    Pemetrexed administered IV plus the investigator's discretion of carboplatin IV or cisplatin IV with pembrolizumab IV.

    Drug: Carboplatin
    Administered IV

    Drug: Cisplatin
    Administered IV

    Drug: Pemetrexed
    Administered IV

    Drug: Pembrolizumab
    Administered IV

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (with Pembrolizumab) [Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)]

      PFS by BICR (with Pembrolizumab)

    2. PFS by BICR (with or without Pembrolizumab) [Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)]

      PFS by BICR (with or without Pembrolizumab)

    Secondary Outcome Measures

    1. Disease Control Rate (DCR) by BICR (with Pembrolizumab) [Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)]

      DCR by BICR (with Pembrolizumab)

    2. DCR by BICR (with or without Pembrolizumab) [Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)]

      DCR by BICR (with or without Pembrolizumab)

    3. PFS2 (with Pembrolizumab) [Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months)]

      PFS2 (with Pembrolizumab)

    4. PFS2 (with or without Pembrolizumab) [Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months)]

      PFS2 (with or without Pembrolizumab)

    5. Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR (with Pembrolizumab) [Baseline through Disease Progression or Death (Estimated at up to 24 Months)]

      ORR: Percentage of Participants with CR or PR by BICR (with Pembrolizumab)

    6. ORR: Percentage of Participants with CR or PR by BICR (with or without Pembrolizumab) [Baseline through Disease Progression or Death (Estimated at up to 24 Months)]

      ORR: Percentage of Participants with CR or PR by BICR (with or without Pembrolizumab)

    7. Duration of Response (DoR) by BICR (with Pembrolizumab) [Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 24 Months)]

      DOR by BICR (with Pembrolizumab)

    8. DOR by BICR (with or without Pembrolizumab) [Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 24 Months)]

      DOR by BICR (with or without Pembrolizumab)

    9. Overall Survival (OS) (with Pembrolizumab) [Baseline to Date of Death from Any Cause (Estimated at up to 48 Months)]

      OS (with Pembrolizumab)

    10. OS (with or without Pembrolizumab) [Baseline to Date of Death from Any Cause (Estimated at up to 48 Months)]

      OS (with or without Pembrolizumab)

    11. Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (with Pembrolizumab) [Baseline through Central Nervous System (CNS) Progression or Death (Estimated at up to 24 Months)]

      Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab)

    12. Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab) [Baseline through CNS Progression or Death (Estimated at up to 24 Months)]

      Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab)

    13. Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab) [Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)]

      Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)

    14. Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab) [Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)]

      Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab)

    15. Time to Deterioration of Pulmonary Symptoms (with Pembrolizumab) [Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 Months)]

      Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) (with Pembrolizumab)

    16. Time to Deterioration of Pulmonary Symptoms (with or without Pembrolizumab) [Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 Months)]

      Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-SAQ (with or without Pembrolizumab)

    17. The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement) [Baseline]

      The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)

    18. Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab) [Baseline through CNS Progression or Death (Estimated at up to 24 Months)]

      Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab)

    19. Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab) [Baseline through CNS Progression or Death (Estimated at up to 24 Months)]

      Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab)

    20. Intracranial ORR: Percentage of Participants with Intracranial CR or PR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (with Pembrolizumab) [Baseline through CNS Progression or Death (Estimated at up to 24 Months)]

      Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with Pembrolizumab)

    21. Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab) [Baseline through CNS Progression or Death (Estimated at up to 24 Months)]

      Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab)

    22. Intracranial DOR per RANO-BM by BICR (with Pembrolizumab) [Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)]

      Intracranial DOR per RANO-BM by BICR (with Pembrolizumab)

    23. Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab) [Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)]

      Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab)

    Eligibility Criteria

    Criteria

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

    • Histologically or cytologically confirmed, Stage IIIB-IIIC or Stage IV non-squamous NSCLC that is not suitable for radical surgery or radiation therapy.

    • A RET gene fusion in tumor and/or blood from a qualified laboratory.

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

    • Adequate hematologic, hepatic and renal function.

    • Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of treatment and for 6 months after.

    • Ability to swallow capsules.

    Exclusion Criteria:

    • Additional validated oncogenic drivers in NSCLC if known.

    • Prior systemic therapy for metastatic disease. Treatment (chemotherapy, immunotherapy, or biological therapy) in the adjuvant/neoadjuvant setting is permitted if it was completed at least 6 months prior to randomization.

    • Major surgery within 3 weeks prior to planned start of selpercatinib.

    • Radiotherapy for palliation within 1 week of the first dose of study treatment or any radiotherapy within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung.

    • Symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or untreated spinal cord compression.

    • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 milliseconds.

    • Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.

    • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.

    • Pregnancy or lactation.

    • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed ≥2 years previously and not currently active.

    • Uncontrolled, disease related pericardial effusion or pleural effusion.

    • Requiring chronic treatment with steroids.

    Exclusion Criteria for Participants Receiving Pembrolizumab:

    • History of interstitial lung disease or interstitial pneumonitis.

    • Active autoimmune disease or any illness or treatment that could compromise the immune system.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro de Oncología e Investigación de Buenos Aires Berazategui Buenos Aires Argentina B1884BBF
    2 Fundacion CENIT para la Investigacion en Neurociencias Caba Buenos Aires Argentina C1125ABD
    3 Clinica Viedma S. A Viedma Río Negro Argentina R8500ACE
    4 Instituto Alexander Fleming Ciudad de Buenos Aires Argentina 1426
    5 Clínica El Castaño San Juan Argentina J5400ARW
    6 Chris O'Brien Lifehouse Camperdown New South Wales Australia 2050
    7 Calvary Mater Newcastle Waratah New South Wales Australia 2298
    8 Westmead Hospital Westmead New South Wales Australia 2145
    9 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    10 Monash Medical Centre Clayton Victoria Australia 3168
    11 Slade Pharmacy Frankston Victoria Australia 3149
    12 Peter MacCallum Cancer Centre Melbourne Victoria Australia 3000
    13 St Vincent's Hospital Melbourne Victoria Australia 3065
    14 Peninsula & South Eastern Haematology and Oncology Group Frankston Australia 3199
    15 ZNA Middelheim Antwerp Antwerpen Belgium 2020
    16 Universitair Ziekenhuis Brussel Jette Brussel Belgium 1090
    17 AZ Delta Roeselare West Flanders Belgium 8800
    18 UZ Gent Hospital Gent Belgium 9000
    19 Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium 3000
    20 AZ Sint-Maarten, Campus Leopoldstraat 2 Mechelen Belgium 2800
    21 CHU UCL Namur/Site Sainte Elisabeth Namur Belgium 5000
    22 VITAZ Sint Niklaas Belgium 9100
    23 Núcleo de Oncologia da Bahia Salvador Bahia Brazil 41170-110
    24 Oncocentro BH Belo Horizonte Minas Gerais Brazil 30260-680
    25 Hospital de Cancer de Londrina Londrina Paraná Brazil 86015-520
    26 Hospital São Lucas da PUCRS Porto Alegre Rio Grande Do Sul Brazil 90610-000
    27 Instituto de Educação, Pesquisa e Gestão em Saúde Rio de Janeiro RJ Brazil 22793-080
    28 Fundação Pio XII - Hospital de Câncer de Barretos Barretos Sao Paulo Brazil 14784-400
    29 Clinica Onco Star Sao Paulo SP Brazil 04501-000
    30 Hospital PUC-CAMPINAS Campinas São Paulo Brazil 13060-904
    31 Hospital das Clinicas da FMRP Ribeirao Preto São Paulo Brazil 14048-900
    32 INCA Hospital do Câncer III Rio de Janeiro Brazil 20231
    33 Oncoclinicas Rio de Janeiro S.A. Rio de Janeiro Brazil 22250-905
    34 Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology Sao Paolo Brazil 01308-050
    35 Icesp - Instituto Do Câncer Do Estado de São Paulo Sao Paulo Brazil 01246000
    36 Centro Paulista de Oncologia São Paulo Brazil 04538-133
    37 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    38 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    39 Beijing Cancer hospital Beijing Beijing China 100142
    40 First affiliated Hospital of Sun Yat-Sen University Guangzhou Guangdong China 510080
    41 The First Affiated Hospital Of Guangzhou Medical Collage Guangzhou Guangzhou China 510120
    42 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150081
    43 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei China 430022
    44 Hunan Cancer Hospital Changsha Hunan China 410013
    45 Changzhou No.2 People's Hospital Changzhou Jiangsu China
    46 Xuzhou Central Hospital Xuzhou Jiangsu China 221018
    47 Jilin Cancer Hospital Changchun Jilin China
    48 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032
    49 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433
    50 West China Hospital of Sichuan University Cheng Du Sichuan China 610041
    51 Xinjiang Medical University Cancer Hospital Urumqi Xinjiang China 830000
    52 Sir Run Run Shaw Hospital Hangzhou Zhejiang China 310016
    53 Zhejiang Cancer Hospital Hangzhou Zhejiang China
    54 People's Hospital of Hunan Province Changsha China 410002
    55 First Affiliated Hosp of College of Med, Zhejiang University Hangzhou China 310003
    56 Shanghai Chest Hospital Shanghai China 200030
    57 Fakultni nemocnice Olomouc Olomouc Czechia 779 00
    58 Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni Ostrava - Vitkovice Czechia 70384
    59 Fakultni nemocnice Bulovka Praha 8 Czechia 180 81
    60 Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne Clermont-Ferrand Puy-de-Dôme France 63011
    61 Centre Leon Berard Lyon Rhône-Alpes France 69008
    62 CHU Grenoble Alpes- Hopital Albert Michallon Cs10217 Grenoble Cedex 9 France 38049
    63 Assistance Publique Hôpitaux de Marseille - Hôpital Nord Marseille Cedex 20 France 13915
    64 Institut du Cancer de Montpellier - Val d'aurelle Montpellier Cedex 5 France 34298
    65 Hopital Cochin Paris France 75014
    66 Thoraxklinik-Heidelberg gGmbH Heidelberg Baden-Württemberg Germany 69126
    67 Asklepios Fachkliniken München-Gauting Gauting Bayern Germany 82131
    68 Klinikverbund Kempten-Oberallgäu Immenstadt Bayern Germany 87509
    69 Franziskus-Hospital Harderberg Georgsmarienhütte Niedersachsen Germany 49124
    70 Universitätsmedizin Göttingen Göttingen Niedersachsen Germany 37075
    71 Universitätsklinikum Köln Köln Nordrhein-Westfalen Germany 50937
    72 LungenClinic Grosshansdorf Grosshansdorf Schleswig-Holstein Germany 22927
    73 Charité Campus Virchow-Klinikum Berlin Germany 12203
    74 Sotiria Thoracic Diseases Hospital of Athens Athens Attikí Greece 11527
    75 University General Hospital of Heraklion Heraklion Irakleío Greece 711 10
    76 European Interbalkan Medical Center Thessaloniki Thessaloníki Greece 570 01
    77 G. Papanikolaou General Hospital Thessaloniki Thessaloníki Greece 570 10
    78 Hong Kong United Oncology Centre Jordan Kowloon Hong Kong 999077
    79 Prince of Wales Hospital Shatin Hong Kong 852
    80 Soroka Medical Center - Pediatric Outpatient Clinic Beer-Sheva Israel 8410101
    81 Rambam Medical Center Haifa Israel 3525408
    82 Shaare Zedek Medical Center Jerusalem Israel 9103102
    83 Hadassah Medical Center Jerusalem Israel 9112001
    84 Sheba Medical Center Ramat Gan Israel 5262000
    85 Istituto Nazionale Tumori IRCCS Fondazione Pascale Napoli Campania Italy 80131
    86 Azienda Ospedaliera San Camillo Forlanini Roma Lazio Italy 00152
    87 Policlinico Gemelli - Università Cattolica del Sacro Cuore Roma Lazio Italy 00168
    88 ASST Grande Ospedale Metropolitano Niguarda Milan Milano Italy 20162
    89 Azienda Ospedaliera San Gerardo Monza Milano Italy 20052
    90 Istituto Clinico Humanitas Rozzano Milano Italy 20089
    91 Centro di Riferimento Oncologico Aviano Pordenone Italy 33081
    92 Azienda Sanitaria Ospedaliera S Luigi Gonzaga Orbassano Torino Italy 10043
    93 Ospedale G. Moscati Avellino Italy 50019
    94 IRCCS - AOU di Bologna Bologna Italy 40138
    95 Azienda Ospedlaliero-Univeristaria Pisana, Stabilimento Ospedaliero di Cisanello Pisa Italy 56125
    96 Ospedale Santa Maria delle Croci Ravenna Italy 48121
    97 I.F.O. Istituto Nazionale Tumori Regina Elena Roma Italy 00144
    98 National Cancer Center Hospital East Kashiwa Chiba Japan 277-8577
    99 Hokkaido University Hospital Sapporo Hokkaido Japan 060-8648
    100 Kanazawa University Hospital Kanazawa Ishikawa Japan 920-8641
    101 Kanagawa cancer center Yokohama Kanagawa Japan 241-8515
    102 Kindai University Hospital Osaka Sayama-shi Osaka Japan 589 8511
    103 Shizuoka Cancer Center Nagaizumi Shizuoka Japan 411-8777
    104 National Cancer Center Hospital Chuo-ku Tokyo Japan 104-0045
    105 Japanese Foundation for Cancer Research Koto Tokyo Japan 135-8550
    106 Tottori University Hospital Yonago Tottori Japan 683-8504
    107 Okayama University Hospital Okayama Japan 700-8558
    108 Osaka International Cancer Institute Osaka Japan 541-8567
    109 National Cancer Center Goyang-si Gyeonggi-do Korea, Republic of 10408
    110 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620
    111 Gyeongsang National University Hospital Jin-ju-si Gyeongsangnam-do Korea, Republic of 52727
    112 Gachon University Gil Medical Center Incheon Korea Korea, Republic of 21565
    113 Asan Medical Center Seoul Korea Korea, Republic of 05505
    114 Seoul St. Mary's Hospital Seoul Korea Korea, Republic of 06591
    115 Seoul National University Hospital Seoul Seoul, Korea Korea, Republic of 03080
    116 Konyang University Hospital Daejon Korea, Republic of 35365
    117 Samsung Medical Center Seoul Korea, Republic of 06351
    118 Seoul Municipal Boramae Hospital Seoul Korea, Republic of 07061
    119 Health Pharma Professional Research S.A. de C.V: Mexico City Federal District Mexico 03100
    120 Actualidad Basada en la Investigación del Cáncer Guadalajara Jalisco Mexico 44680
    121 Oncologico Potosino, S.C. San Luis Potosí Mexico 78209
    122 Ziekenhuis St. Jansdal Harderwijk Gelderland Netherlands 3844 DG
    123 Jeroen Bosch Hospital Den Bosch Noord-Brabant Netherlands 5223 GZ
    124 Vrije Universiteit Medisch Centrum Amsterdam Amsterdam Netherlands 1081 HV
    125 Erasmus Medisch Centrum Rotterdam Netherlands 3015 GD
    126 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-214
    127 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Warszawa Poland 02-781
    128 Institutul Oncologic Bucharest București Romania 22328
    129 Gral Medical SRL Bucuresti București Romania 031422
    130 Cabinet Medical Oncomed Timișoara Timiș Romania 300239
    131 Spitalul Universitar de Urgență București Bucuresti Romania 050098
    132 Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca Cluj-Napoca Romania 400015
    133 Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta Constanta Romania 900591
    134 Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava Romania 720237
    135 GBUZ Republican Clinical Oncological Dispensary Ufa Baškortostan, Respublika Russian Federation 450054
    136 Samara Regional Clinical Oncology Center Samara Samarskaya Oblast' Russian Federation 443031
    137 N.N.Petrov Research Institute of Oncology Saint Petersburg Sankt-Peterburg Russian Federation 197758
    138 Arkhangelsk Clinical Oncological Dispensary Arkhangelsk Russian Federation 163045
    139 SHI Kaluga Regional Hospital Kaluga Russian Federation 248007
    140 Republic Oncology Dispensary of MoH of Republic Tatarstan Kazan Russian Federation 420029
    141 First Moscow State Medical University n.a. Sechenov Moscow Russian Federation 119991
    142 Hadassah Medical LTD Moscow Russian Federation 121205
    143 Murmansk Regional Clinical Hospital Murmansk Russian Federation 183047
    144 St-Petersburg scientifical practical cente spec medical care St. Petersburg Russian Federation 197758
    145 National Cancer Centre Singapore Singapore Central Singapore Singapore 169610
    146 Tan Tock Seng Hospital Singapore Singapore 308433
    147 Hospital Fundacion Son Llatzer Palma de Mallorca Baleares Spain 07198
    148 CHUS - Hospital Clinico Universitario Santiago de Compostela Galicia [Galicia] Spain 15706
    149 Hospital Insular de Gran Canaria Las palmas de gran canaria Las Palmas Spain 35016
    150 Hospital Puerta De Hierro Majadahonda Madrid Spain 28222
    151 Clinica Universitaria De Navarra Pamplona Navarra Spain 31008
    152 Hospital General Universitario de Alicante Alicante Spain 03010
    153 Hospital Germans Trias i Pujol Badalona Spain 08916
    154 Hospital del Mar Barcelona Spain 08003
    155 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025
    156 Hospital Universitari Dexeus Barcelona Spain 08028
    157 Institut Catala d'Oncologia Barcelona Spain 08908
    158 Complejo Hospitalario de Jaén Jaén Spain 23007
    159 Hospital Universitario Ramón y Cajal Madrid Spain 28034
    160 Hospital Clinico San Carlos Madrid Spain 28040
    161 Hospital Universitario 12 de Octubre Madrid Spain 28041
    162 Hospital Universitario La Paz Madrid Spain 28046
    163 Hospital Regional Universitario Malaga Spain 29010
    164 Hospital De Navarra Pamplona Spain 31008
    165 Hospital Universitario Virgen Macarena Sevilla Spain 41009
    166 Hospital Universitario Virgen Del Rocio Sevilla Spain 41013
    167 Hospital Clínico Universitario de Valencia Valencia Spain 46010
    168 Hospital Universitario La Fe de Valencia Valencia Spain 46026
    169 Changhua Christian Hospital Changhua County Changhua Taiwan 50006
    170 Buddhist Dalin Tzu Chi General Hospital Dalin Town Chiayi Taiwan 62247
    171 Chang Gung Memorial Hospital - Linkou Guei Shan Township Taoyuan County Taiwan 333
    172 E-Da hospital Kaohsiung Taiwan 82445
    173 Chang Gung Memorial Hospital - Kaohsiung Branch Kaohsiung Taiwan 833
    174 Tri-Service General Hospital Neihu Taipei Taiwan 11490
    175 Taipei Medical University Shuang Ho Hospital New Taipei Taiwan 23561
    176 Chung Shan Medical University Hospital Taichung Taiwan 402
    177 China Medical University Hospital Taichung Taiwan 40447
    178 Taichung Veterans General Hospital Taichung Taiwan 40705, ROC
    179 Chi Mei Hospital - Liouying Branch Tainan City Taiwan 736
    180 National Cheng-Kung Uni. Hosp. Tainan Taiwan 704
    181 National Taiwan University Hospital Taipei City Taiwan 10048
    182 Taipei Veterans General Hospital Taipei Taiwan 11217
    183 Ege University Medicine of Faculty Bornova İzmir Turkey 35100
    184 Baskent University Dr. Turgut Noyan Research and Training Center Adana Turkey 1250
    185 Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital Ankara Turkey 06200
    186 Hacettepe University Faculty of Medicine Ankara Turkey 6100
    187 Dicle Üniversitesi Diyarbakir Turkey 21100
    188 Trakya University Edirne Turkey 22030
    189 Istanbul Medeniyet University Istanbul Turkey 34732
    190 Izmir Ataturk Training and Research Hospital Izmir Turkey 35360
    191 Izmir Medical Park Hospital Izmir Turkey 35575
    192 Memorial Antalya Hastanesi Kepez Turkey 07020
    193 Inonu Universitesi Turgut Ozal Tıp Merkezi Malatya Turkey 44280
    194 Maslak Acıbadem Hstanesi Sarıyer Turkey 34457
    195 Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Medical University" Dnipro Dnipropetrovska Oblast Ukraine 49102
    196 CNPE "Regional Center of Oncology" Kharkiv Kharkivska Oblast Ukraine 61070
    197 Sumy regional clinical oncological dispensary Sumy Sumska Oblast Ukraine 40022
    198 Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" Vinnytsia Vinnytska Oblast Ukraine 21029
    199 Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council Lutsk Volynska Oblast Ukraine 43018
    200 Chernivtsi Regional Oncological Dispensary Chernivtsi Ukraine 58013
    201 Medical Center "Mriya Med-Service", LLC Kryvyi Rig Ukraine 50019
    202 Kyiv City Clinical Oncological Center Kyiv Ukraine 03115
    203 Odessa Regional Oncology Dispensary Odesa Ukraine 65000
    204 CI Odesa Regional Clinical Hospital Odesa Ukraine 65025
    205 Medical center "Oncolife" Zaporizhya Ukraine 69000
    206 City Hospital, Nottingham University Hospitals Nottingham Nottinghamshire United Kingdom NG5 1PB

    Sponsors and Collaborators

    • Loxo Oncology, Inc.
    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Loxo Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT04194944
    Other Study ID Numbers:
    • 17479
    • J2G-MC-JZJC
    • 2019-001979-36
    First Posted:
    Dec 11, 2019
    Last Update Posted:
    Aug 19, 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
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Loxo Oncology, Inc.
    targeted therapy
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Carboplatin
    Pembrolizumab
    Pemetrexed

    Study Results

    No Results Posted as of Aug 19, 2022