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LIBRETTO-432: A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

Sponsor
Loxo Oncology, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04819100
Collaborator
Eli Lilly and Company (Industry)
170
Enrollment
202
Locations
2
Arms
131.4
Anticipated Duration (Months)
0.8
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 placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC
Actual Study Start Date :
Dec 20, 2021
Anticipated Primary Completion Date :
Aug 31, 2028
Anticipated Study Completion Date :
Nov 30, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: Selpercatinib

Selpercatinib administered orally.

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

    		•
    Placebo Comparator: Placebo

    Placebo administered orally.

    Drug: Placebo
    Administered orally.

    Outcome Measures

    Primary Outcome Measures

    1. Event-Free Survival (EFS) [Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]

      EFS by Investigator Assessment in the Primary Analysis Population

    Secondary Outcome Measures

    1. EFS [Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]

      EFS by investigator assessment in the overall population

    2. Overall Survival (OS) [Randomization to death from any cause (estimated as up to 9 years)]]

      OS

    3. EFS [Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]]

      EFS by blinded independent central review (BICR)

    4. Time to Distant Disease Recurrence in the Central Nervous System (CNS) [Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]

      Time to distant disease recurrence in the CNS by investigator assessment and BICR

    5. Progression Free Survival on the Next Line of Treatment (PFS2) [Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)]

      PFS2 by investigator assessment

    6. Positive Predictive Value (PPV) of Local Lab Tests Compared to Central Lab Test to Detect Rearranged during Transfection (RET) Gene Fusion [Baseline]

      PPV of local lab tests compared to central lab test to detect RET gene fusion

    7. Mean Change from Baseline over Time in NSCLC Symptoms [Baseline to treatment discontinuation (estimated as up to 3 years)]

      NSCLC symptoms will be measured using the 7-item NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). The NSCLC-SAQ measures the severity/frequency of the following core symptoms: Cough, pain, dyspnea, fatigue, and appetite. Raw scores range from 0 to 4 and the total score ranges from 0-20. Higher scores represent worse symptoms.

    8. Mean Change from Baseline over Time in Physical Function [Baseline to treatment discontinuation (estimated as up to 3 years)]

      Physical function will be measured by the 5 physical function items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (also known as the EORTC IL 19 questionnaire). Raw scores range from 0-20. Higher scores indicate worst function.

    Eligibility Criteria

    Criteria

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

    • Must have histologically confirmed Stage IB, II, or IIIA NSCLC.

    • Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR) or next generation sequencing (NGS).

    • Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC.

    -- Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion.

    • Must have completely recovered from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization.

    • Maximum time allowed between definitive therapy completion and randomization must be:

    • 10 weeks if no chemotherapy was administered

    • 26 weeks if adjuvant chemotherapy was administered

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

    • 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 the study and for at least 2 weeks after last dose of study drug.

    Exclusion Criteria:

    • Additional oncogenic drivers in NSCLC, if known.

    • Evidence of small cell lung cancer.

    • Clinical or radiologic evidence of disease recurrence or progression following definitive therapy.

    • Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids.

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

    • Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection.

    • Have known active hepatitis B or C.

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

    • Major surgery within 4 weeks prior to planned start of selpercatinib.

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

    • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active.

    • Pregnancy or lactation.

    • Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Hematology Oncology Santa Monica California United States 90404
    2 Stockton Hematology Oncology Medical Group Stockton California United States 95204
    3 UCLA Medical Center Torrance California United States 90502
    4 GenesisCare Aventura Florida United States 33180
    5 GenesisCare - Boca Raton Boca Raton Florida United States 33431
    6 Florida Cancer Specialists Fort Myers Florida United States 33901
    7 Mayo Clinic in Florida Jacksonville Florida United States 32224
    8 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    9 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    10 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    11 Mayo Clinic Rochester Minnesota United States 55905
    12 New York Oncology Hematology, P.C Clifton Park New York United States 12065
    13 Memorial Sloan Kettering Cancer Center New York New York United States 10021
    14 Sarah Cannon Research Institute SCRI Nashville Tennessee United States 37203
    15 Tennessee Oncology PLLC Nashville Tennessee United States 37203
    16 US Oncology The Woodlands Texas United States 77380
    17 University of Vermont Medical Center Burlington Vermont United States 05405
    18 Border Medical Oncology Albury New South Wales Australia 2640
    19 Sunshine Coast University Hospital Birtinya Queensland Australia 4575
    20 The Townsville Hospital Douglas Queensland Australia 4814
    21 Rockhampton Hospital Rockhampton Queensland Australia 4700
    22 Ballarat Oncology and Haematology Ballarat Victoria Australia 3350
    23 Bendigo Health Bendigo Victoria Australia 3550
    24 Goulburn Valley Health Shepparton Victoria Australia 3630
    25 South West Healthcare Warrambool Victoria Australia 3280
    26 Landeskrankenhaus Feldkirch Feldkirch Austria 6800
    27 Klinik Floridsdorf Wien Austria 1210
    28 Cliniques Universitaires Saint-Luc Bruxelles Brussel Belgium 1200
    29 Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne Yvoir Namur Belgium 5000
    30 AZ Delta vzw Roeselare West-Vlaanderen Belgium 8800
    31 Universitair Ziekenhuis Antwerpen Edegem Belgium 2650
    32 Clinique Saint Pierre Ottignies Ottignies Belgium 1340
    33 Núcleo de Oncologia da Bahia Salvador Bahia Brazil 41170-110
    34 Oncocentro BH Belo Horizonte Minas Gerais Brazil 30260-680
    35 COT - Centro Oncológico do Triângulo S.A. Uberlândia Minas Gerais Brazil 38408-150
    36 Multihemo Servicos Medicos S/A Recife Pernambuco Brazil 500070-460
    37 Hospital São Lucas da PUCRS Porto Alegre Rio Grande Do Sul Brazil 90610-000
    38 Instituto de Educação, Pesquisa e Gestão em Saúde Rio de Janeiro RJ Brazil 22793-080
    39 IBCC - Instituto Brasileiro de Controle do Câncer São Paulo Brazil 04014-002
    40 Centro Paulista de Oncologia São Paulo Brazil 04538-133
    41 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    42 Beijing Friendship Hospital Affiliate of Capital University Beijing Beijing China 100050
    43 Beijing Cancer hospital Haidian District Beijing China 100142
    44 Fujian Provincial Hospital Fuzhou Fujian China 350001
    45 Guangdong Provincial People's Hospital Guangzhou Guangdong China 510080
    46 Southern Medical University Nanfang Hospital Guangzhou Guangdong China 510515
    47 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150081
    48 Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China 430022
    49 Xiangya Hospital, Central South University Changsha Hunan China 410008
    50 Hunan Cancer Hospital Changsha Hunan China 410013
    51 Hunan Cancer Hospital Changsha Hunan China 410013
    52 Jilin Cancer Hospital Changchun Jilin China 130000
    53 Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army Xi'an Shaanxi China 710038
    54 Jinan Central Hospital Jinan Shandong China 250013
    55 Shanghai Chest Hospital Shanghai Shanghai China 200030
    56 Zhongshan Hospital, Fudan University Shanghai Shanghai China 200032
    57 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433
    58 the Third People's Hospital of Chengdu Chengdu Sichuan China 610031
    59 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    60 First Affiliated Hosp of College of Med, Zhejiang University Hangzhou Zhejiang China 310003
    61 Zhejiang Cancer Hospital Hangzhou Zhejiang China
    62 Masarykuv onkologicky ustav Brno Czech Republic Czechia 656 53
    63 Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni Ostrava - Vitkovice Czechia 70384
    64 Fakultni nemocnice Bulovka Praha 8 Czechia 180 81
    65 Odense Universitetshospital Odense C Syd Denmark 5000
    66 HCL-Hôpital Louis Pradel Lyon (Bron) France 69677
    67 Centre Leon Berard Lyon Cedex 08 France 69373
    68 Assistance Publique Hôpitaux de Marseille - Hôpital Nord Marseille Cedex 20 France 13915
    69 Hopital Cochin Paris France 75014
    70 CHU Charles Nicolle in Rouen Rouen cedex France 76036
    71 Gustave Roussy Villejuif Cedex France 94805
    72 Thoraxklinik-Heidelberg gGmbH Heidelberg Baden-Württemberg Germany 69126
    73 Asklepios Fachkliniken München-Gauting Gauting Bayern Germany 82131
    74 Lungenfachklinik Immenhausen Immenhausen Hessen Germany 34376
    75 Franziskus-Hospital Harderberg Georgsmarienhütte Lower Saxony Germany 49124
    76 LungenClinic Grosshansdorf Grosshansdorf Schleswig-Holstein Germany 22927
    77 Charité-Campus Benjamin Franklin-Hematology and Oncology Berlin Germany 12203
    78 University Hospital of Patras Patras Achaḯa Greece 26504
    79 Agios Savvas Regional Cancer Hospital Athens Attikí Greece 115 22
    80 Sotiria Thoracic Diseases Hospital of Athens Athens Attikí Greece 11527
    81 University General Hospital of Heraklion Heraklion Krete Greece 71110
    82 European Interbalkan Medical Center Thessaloniki Thessaloníki Greece 570 01
    83 G. Papanikolaou General Hospital Thessaloniki Thessaloníki Greece 570 10
    84 Queen Elizabeth Hospital Hong Kong Hong Kong
    85 Hong Kong United Oncology Centre Kowloon Hong Kong 518000
    86 Princess Margaret Hospital Lai Chi Kok Hong Kong 999077
    87 Rajiv Gandhi Cancer Institute And Research Centre New Delhi Delhi India 110085
    88 Regional Cancer Centre Thiruvananthapuram Kerala India 695011
    89 Tata Memorial Hospital Mumbai Maharashtra India 400012
    90 Rashtrasant Tukdoji Regional Cancer Hospital and Research Centre (RSTRCH) Nagpur Maharashtra India 440027
    91 HCG Manavata Cancer Centre Nashik Maharashtra India 422001
    92 Rambam Medical Center Haifa Israel 3109601
    93 Hadassah Medical Center Jerusalem Israel 9112001
    94 Sheba Medical Center Ramat Gan Israel 5265601
    95 ASST Grande Ospedale Metropolitano Niguarda Milan Milano Italy 20162
    96 Istituto Clinico Humanitas Rozzano Milano Italy 20089
    97 Azienda Ospedaliera Dei Colli Naples Napoli Italy 80131
    98 Azienda Sanitaria Ospedaliera S Luigi Gonzaga Orbassano Torino Italy 10043
    99 Istituto Oncologico Veneto IRCCS Padova Veneto Italy 35128
    100 IRCCS Ospedale Oncologico di Bari Bari Italy 70124
    101 Aichi Cancer Center Hospital Nagoya Aichi Japan 464-8681
    102 National Cancer Center Hospital East Kashiwa Chiba Japan 277-8577
    103 Himeji Medical Center Himeji Hyogo Japan 670-8520
    104 Kanagawa cancer center Yokohama Kanagawa Japan 241-8515
    105 Niigata Cancer Center Hospital Niigata-shi Niigata Japan 951-8566
    106 Shizuoka Cancer Center Nagaizumi Shizuoka Japan 411-8777
    107 Japanese Foundation for Cancer Research Koto Tokyo Japan 135-8550
    108 Tottori University Hospital Yonago Tottori Japan 683-8504
    109 Hiroshima University Hospital Hiroshima Japan 734-8551
    110 Osaka International Cancer Institute Osaka Japan 541-8567
    111 National Cancer Center Goyang-si Gyeonggi-do Korea, Republic of 10408
    112 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620
    113 Chonnam National University Hwasun Hospital Hwasun-gun Jeollanam Do Korea, Republic of 58128
    114 Asan Medical Center Seoul Korea Korea, Republic of 05505
    115 Korea University Guro Hospital Seoul Korea Korea, Republic of 08308
    116 Seoul National University Hospital Seoul Seoul, Korea Korea, Republic of 03080
    117 Kyungpook National University Medical Center Chilgok Hospital Daegu Korea, Republic of 41404
    118 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    119 Samsung Medical Center Seoul Korea, Republic of 06351
    120 Actualidad Basada en la Investigación del Cáncer Guadalajara Jalisco Mexico 44680
    121 ONCARE Viaducto Nápoles Delegación Benito Juárez Mexico City, Federal District Mexico 03810
    122 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 64460
    123 Avix Investigación Clinica, S.C. Monterrey Nuevo León Mexico 64710
    124 Ziekenhuis St. Jansdal Harderwijk Gelderland Netherlands 3844 DG
    125 Universitair Medisch Centrum St Radboud Nijmegen Nijmegen Netherlands 6525 GA
    126 Krakowski Szpital Specjalistyczny im. Jana Pawa II Krakow Małopolskie Poland 30-002
    127 Wielkopolskie Centrum Pulmonologii i Torakochirurgii Poznan Wielkopolskie Poland 60-569
    128 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-214
    129 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Warszawa Poland 02-781
    130 Pan American Center for Oncology Trials Rio Piedras Puerto Rico 00935
    131 Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca Cluj-Napoca Romania 400015
    132 Arkhangelsk Clinical Oncological Dispensary Arkhangelsk Arkhangel'skaya Oblast' Russian Federation 163045
    133 Hadassah Medical LTD Moscow Russian Federation 121205
    134 National medical research center of oncology n. a. N. N. Petrov Saint Petersburg Russian Federation 197758
    135 EuroCityClinic Saint-Petersburg Russian Federation 197022
    136 Parkway Cancer Centre Singapore Singapore 258499
    137 Tan Tock Seng Hospital Singapore Singapore 308433
    138 Hospital Universitario Puerta del Mar Cádiz Andalucía Spain 11009
    139 Hospital Universitario Central de Asturias Oviedo Asturias Spain 33011
    140 Hospital de Mataró Mataró Barcelona [Barcelona] Spain 8304
    141 CHUS - Hospital Clinico Universitario Santiago de Compostela Galicia [Galicia] Spain 15706
    142 Hospital Universitario Virgen de la Arrixaca El Palmar Murcia Spain 30120
    143 Hospital Álvaro Cunqueiro Vigo Pontevedra Spain 36212
    144 Hospital Universitario de Canarias Santa Cruz de Tenerife Tenerife Spain 38320
    145 Hospital General de Albacete Albacete Spain 02006
    146 Hospital Germans Trias i Pujol Badalona Spain 08916
    147 Hospital del Mar Barcelona Spain 08003
    148 Hospital Universitari Dexeus Barcelona Spain 08028
    149 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    150 Hospital Clinic I Provincial Barcelona Spain 08036
    151 Institut Catala d'Oncologia Barcelona Spain 08908
    152 Hospital Reina Sofia Cordoba Spain 14004
    153 Complejo Asistencial Universitario de León - Hospital de León Leon Spain 24071
    154 Hospital Lucus Augusti Lugo Spain 27003
    155 MD Anderson Madrid Spain 28033
    156 Hospital Universitario Ramón y Cajal Madrid Spain 28034
    157 Hospital Clinico San Carlos Madrid Spain 28040
    158 Hospital Universitario 12 de Octubre Madrid Spain 28041
    159 Hospital Regional Universitario Malaga Spain 29010
    160 Hospital Santa Maria Nai Ourense Spain 15009
    161 Hospital Son Llàtzer-ONCOLOGY Palma de Mallorca Spain 07198
    162 Hospital Universitari Sant Joan de Reus Reus Spain 43204
    163 Hospital Universitario Virgen Macarena Sevilla Spain 41009
    164 Hospital Universitario La Fe de Valencia Valencia Spain 46026
    165 Sahlgrenska Universitetssjukhuset Göteborg Sweden 41345
    166 Changhua Christian Hospital Changhua City Changhua County Taiwan 50006
    167 Chi Mei Hospital - Liouying Branch Tainan City Tainan Taiwan 73657
    168 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    169 Chang Gung Memorial Hospital - Kaohsiung Branch Kaohsiung Taiwan 83301
    170 Chung Shan Medical University Hospital Taichung Taiwan 402
    171 Taichung Veterans General Hospital Taichung Taiwan 40705, ROC
    172 National Taiwan University Cancer Centre Taipei City Taiwan 10048
    173 National Taiwan University Hospital Taipei City Taiwan 10048
    174 Taipei Veterans General Hospital Taipei Taiwan 11217
    175 Chang Gung Memorial Hospital - Linkou Taoyuan City Taiwan 333
    176 Izmir Medical Park Hospital Izmir Karşıyaka/İzmir Turkey 35575
    177 Baskent University Dr. Turgut Noyan Research and Training Center Adana Turkey 01250
    178 Adana Sehir Hastanesi Adana Turkey 4522
    179 Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital Ankara Turkey 06200
    180 Ankara City Hospital Ankara Turkey 06800
    181 Uludag Universitesi Bursa Turkey 16059
    182 Dicle University Diyarbakir Turkey 21280
    183 Trakya University Edirne Turkey 22030
    184 Medipol Mega University Hospital Istanbul Turkey 34214
    185 Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi Istanbul Turkey 34722
    186 Ege University Medicine of Faculty Izmir Turkey 35100
    187 Izmir Katip Celebi University Training and Research Hospital Oncology Izmir Turkey 35360
    188 Memorial Antalya Hastanesi Kepez Turkey 07020
    189 Inonu University Medical Faculty Oncology Malatya Turkey 44280
    190 Maslak Acıbadem Hstanesi Sarıyer Turkey 34457
    191 CNPE "Regional Center of Oncology" Kharkiv Kharkivska Oblast Ukraine 61070
    192 Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" Vinnytsia Vinnytska Oblast Ukraine 21029
    193 Medical Center "Mriya Med-Service", LLC Kryvyi Rig Ukraine 50019
    194 Kyiv City Clinical Oncological Center Kyiv Ukraine 03115
    195 Communal Enterprise "Odesa Regional Clinical Hospital" Odesa Ukraine 65117
    196 University clinic of Sumy State University Sumy Ukraine 40000
    197 Medical center "Oncolife" Zaporizhya Ukraine 69000
    198 University College Hospital - London London Greater London United Kingdom NW1 2BU
    199 Royal Brompton Hospital London Kensington And Chelsea United Kingdom SW3 6NP
    200 The Clatterbridge Cancer Centre Bebbington Merseyside United Kingdom CH63 4JY
    201 New Cross Hospital Wolverhampton West Midlands United Kingdom WV10 0QP
    202 City Hospital, Nottingham University Hospitals Nottingham 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:
    NCT04819100
    Other Study ID Numbers:
    • 18126
    • J2G-MC-JZJX
    • 2020-005191-35
    First Posted:
    Mar 26, 2021
    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
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 19, 2022