Clinical trial NCT04194944: A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: targeted therapy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2019-12-11
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab)
timeFrame: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
measure: PFS by BICR (With or Without Pembrolizumab)
timeFrame: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
Secondary outcomes:
measure: Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab)
timeFrame: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
measure: Percentage of Participant With DCR by BICR (With or Without Pembrolizumab)
timeFrame: Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
measure: PFS2 (With Pembrolizumab)
timeFrame: Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months
measure: PFS2 (With or Without Pembrolizumab)
timeFrame: Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months
measure: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab)
timeFrame: Baseline through Disease Progression or Death Up to 31 Months
measure: ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab)
timeFrame: Baseline through Disease Progression or Death Up to 31 Months
measure: Duration of Response (DoR) by BICR (With Pembrolizumab)
timeFrame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months
measure: DOR by BICR (With or Without Pembrolizumab)
timeFrame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months
measure: Overall Survival (OS) (With Pembrolizumab)
timeFrame: Baseline to Date of Death from Any Cause Up to 38 Months
measure: OS (With or Without Pembrolizumab)
timeFrame: Baseline to Date of Death from Any Cause Up to 38 Months
measure: Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (With Pembrolizumab)
timeFrame: Baseline through Central Nervous System (CNS) Progression or Death up to 31 Months
measure: Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST 1.1 by BICR (With or Without Pembrolizumab)
timeFrame: Baseline through CNS Progression or Death Up to 31 Months
measure: Median Intracranial DOR Per RECIST 1.1 by BICR (With Pembrolizumab)
timeFrame: Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months
measure: Median Intracranial DOR Per RECIST 1.1 by BICR (With or Without Pembrolizumab)
timeFrame: Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months
measure: Time to Deterioration of Pulmonary Symptoms (With Pembrolizumab)
timeFrame: Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months
measure: Time to Deterioration of Pulmonary Symptoms (With or Without Pembrolizumab)
timeFrame: Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months
measure: 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)
timeFrame: Baseline
measure: Median Time to CNS Progression Per RECIST 1.1 by BICR (With Pembrolizumab)
timeFrame: Baseline through CNS Progression or Death Up to 31 Months
measure: Median Time to CNS Progression Per RECIST 1.1 by BICR (With or Without Pembrolizumab)
timeFrame: Baseline through CNS Progression or Death Up to 31 Months
measure: Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (With Pembrolizumab)
timeFrame: Baseline through CNS Progression or Death Up to 31 Months
measure: Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RANO-BM by BICR (With or Without Pembrolizumab)
timeFrame: Baseline through CNS Progression or Death Up to 31 Months
measure: Intracranial DOR Per RANO-BM by BICR (With Pembrolizumab)
timeFrame: Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months
measure: Intracranial DOR Per RANO-BM by BICR (With or Without Pembrolizumab)
timeFrame: Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months
Other outcomes:
Locations:
city: Berazategui
country: Argentina
facility: Centro de Oncología e Investigación de Buenos Aires
state: Buenos Aires
city: Caba
country: Argentina
facility: Fundacion CENIT para la Investigacion en Neurociencias
state: Buenos Aires
city: Viedma
country: Argentina
facility: Clinica Viedma
state: Río Negro
city: Ciudad de Buenos Aires
country: Argentina
facility: Alexander Fleming
city: San Juan
country: Argentina
facility: Clínica El Castaño
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Oncology Centre
city: Brussels
country: Belgium
facility: UZ Brussel
state: Bruxelles-Capitale, Région De
city: Sint Niklaas
country: Belgium
facility: AZ Nikolaas
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ Delta
state: West Flanders
city: Gent
country: Belgium
facility: UZ Gent Hospital
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten, Campus Leopoldstraat 2
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia
state: Bahia
city: Londrina
country: Brazil
facility: Hospital de Cancer de Londrina
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Grupo COI - Clínicas Oncológicas Integradas
state: RJ
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR)
state: SP
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA
city: Rio de Janeiro
country: Brazil
facility: Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
city: Sao Paolo
country: Brazil
facility: Hospital Sírio Libanês
city: Sao Paulo
country: Brazil
facility: Icesp - Instituto Do Câncer Do Estado de São Paulo
city: São Paulo
country: Brazil
facility: Hospital Sírio Libanês
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Guangzhou
country: China
facility: First affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiated Hospital Of Guangzhou Medical Collage
state: Guangzhou
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: First Affiliated Hosp of College of Med, Zhejiang University
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava - Vitkovice
country: Czechia
facility: Nemocnice AGEL Ostrava - Vitkovice a.s.
city: Praha 8
country: Czechia
facility: Fakultni nemocnice Bulovka
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
state: Bouches-du-Rhône
city: Montpellier Cedex 5
country: France
facility: Institut Régional du Cancer Montpellier
state: Hérault
city: La Tronche
country: France
facility: Chu Grenoble Alpes
state: Isère
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
state: Puy-de-Dôme
city: Lyon
country: France
facility: Centre Leon Berard
state: Rhône-Alpes
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH
state: Baden-Württemberg
city: Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting
state: Bayern
city: Immenstadt
country: Germany
facility: Klinikverbund Kempten-Oberallgäu
state: Bayern
city: Georgsmarienhütte
country: Germany
facility: Franziskus-Hospital Harderberg
state: Niedersachsen
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
state: Niedersachsen
city: Köln
country: Germany
facility: University Hospital of Cologne
state: Nordrhein-Westfalen
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital of Athens
state: Attikí
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Krítí
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: G. Papanikolaou General Hospital
state: Thessaloníki
city: Jordan
country: Hong Kong
facility: Hong Kong United Oncology Centre
state: Kowloon
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: Ḥeifā
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale
state: Campania
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Cro-Irccs
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: Lazio
city: Monza
country: Italy
facility: Ospedale San Gerardo-ASST Monza
state: Lombardia
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Milano
city: Rozzano
country: Italy
facility: Humanitas
state: Milano
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga
state: Torino
city: Avellino
country: Italy
facility: Azienda Ospedaliera San Giuseppe Moscati
city: Bologna
country: Italy
facility: IRCCS - AOU di Bologna
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa cancer center
state: Kanagawa
city: Osaka Sayama-shi
country: Japan
facility: Kindai University Hospital- Osakasayama Campus
state: Osaka
city: Nagaizumi
country: Japan
facility: Tominaga Hospital
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Korea
city: Jin-ju-si
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Kyǒngsangnam-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul, Korea
city: Dongjak-gu
country: Korea, Republic of
facility: Boramae Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Daejon
country: Korea, Republic of
facility: Konyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Mexico City
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V:
state: Federal District
city: Guadalajara
country: Mexico
facility: Actualidad Basada en la Investigación del Cáncer
state: Jalisco
city: San Luis Potosí
country: Mexico
facility: Oncologico Potosino, S.C.
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal
state: Gelderland
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Hospital
state: Noord-Brabant
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie VUmc
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
city: Bucharest
country: Romania
facility: Institutul Oncologic
state: București
city: Bucuresti
country: Romania
facility: Gral Medical Diagnostic Center
state: București
city: Constanta
country: Romania
facility: Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
state: Constanța
city: Timișoara
country: Romania
facility: Cabinet Medical Oncomed
state: Timiș
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgență București
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic
city: Suceava
country: Romania
facility: Spitalul Județean Sfântul Ioan cel Nou Suceava
city: Ufa
country: Russian Federation
facility: GBUZ Republican Clinical Oncological Dispensary
state: Baškortostan, Respublika
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Oncology Center
state: Kalužskaja Oblast
city: Murmansk
country: Russian Federation
facility: Murmansk Regional Clinical Hospital P.A. Bayandina
state: Murmanskaya Oblast'
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Oncology Center
state: Samarskaya Oblast'
city: Saint Petersburg
country: Russian Federation
facility: Scientific research institution of oncology named after N.N. Petrov
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (oncological) named afte -T
state: Sankt-Peterburg
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University I.M. Sechenov
city: Moscow
country: Russian Federation
facility: Hadassah Medical
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Palma de Mallorca
country: Spain
facility: Hospital Fundacion Son Llatzer
state: Baleares
city: Badalona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Badalona
state: Barcelona [Barcelona]
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: Galicia [Galicia]
city: Las palmas de gran canaria
country: Spain
facility: Hospital Insular de Gran Canaria
state: Las Palmas
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria De Navarra
state: Navarra
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Parc de Salut Mar - Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: Barcelona
country: Spain
facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua
city: Dalin Town
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
state: Chiayi
city: Guei Shan Township
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
state: Taoyuan County
city: Kaohsiung
country: Taiwan
facility: E-Da hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
city: Neihu Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital - Liouying Branch
city: Tainan
country: Taiwan
facility: National Cheng-Kung Uni. Hosp.
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bornova
country: Turkey
facility: Ege Universitesi Hastanesi
state: İzmir
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine
city: Antalya
country: Turkey
facility: Memorial Antalya Hastanesi
city: Diyarbakir
country: Turkey
facility: Dicle Üniversitesi
city: Edirne
country: Turkey
facility: Trakya University
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
city: Izmir
country: Turkey
facility: zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi
city: Izmir
country: Turkey
facility: Izmir Medical Park Hospital
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tıp Merkezi
city: Sarıyer
country: Turkey
facility: Acıbadem Maslak Hastanesi
city: Dnipro
country: Ukraine
facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Medical University"
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: CNPE "Regional Center of Oncology"
state: Kharkivska Oblast
city: Odesa
country: Ukraine
facility: Odessa Regional Oncology Center
state: Odeska Oblast
city: Sumy
country: Ukraine
facility: Sumy regional clinical oncological dispensary
state: Sumska Oblast
city: Vinnytsia
country: Ukraine
facility: Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
state: Vinnytska Oblast
city: Lutsk
country: Ukraine
facility: Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
state: Volynska Oblast
city: Zaporizhya
country: Ukraine
facility: "Oncolife" LLC
state: Zaporizka Oblast
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"
city: Kryvyi Rig
country: Ukraine
facility: Medical Center "Mriya Med-Service", LLC
city: Kyiv
country: Ukraine
facility: Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Counci -T
city: Odesa
country: Ukraine
facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals
state: Nottinghamshire
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Claerhout S, Lehnert S, Vander Borght S, Spans L, Dooms C, Wauters E, Vansteenkiste J, Weynand B, Deraedt K, Bourgain C, Vanden Bempt I. Targeted RNA sequencing for upfront analysis of actionable driver alterations in non-small cell lung cancer. Lung Cancer. 2022 Apr;166:242-249. doi: 10.1016/j.lungcan.2022.02.013. Epub 2022 Mar 1.
citation: Solomon BJ, Zhou CC, Drilon A, Park K, Wolf J, Elamin Y, Davis HM, Soldatenkova V, Sashegyi A, Lin AB, Lin BK, F Loong HH, Novello S, Arriola E, Perol M, Goto K, Santini FC. Phase III study of selpercatinib versus chemotherapy +/- pembrolizumab in untreated RET positive non-small-cell lung cancer. Future Oncol. 2021 Mar;17(7):763-773. doi: 10.2217/fon-2020-0935. Epub 2020 Nov 5.