A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
LIBRETTO-431
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
3 other identifiers
interventional
261
26 countries
196
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Feb 2020
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
196 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 11, 2019
CompletedStudy Start
First participant enrolled
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedResults Posted
Study results publicly available
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
ExpectedOctober 21, 2025
October 1, 2025
3.2 years
December 9, 2019
May 3, 2024
October 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab)
PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease.
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
PFS by BICR (With or Without Pembrolizumab)
PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease.
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
Secondary Outcomes (23)
Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab)
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
Percentage of Participant With DCR by BICR (With or Without Pembrolizumab)
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
PFS2 (With Pembrolizumab)
Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months
PFS2 (With or Without Pembrolizumab)
Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months
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 Up to 31 Months
- +18 more secondary outcomes
Study Arms (2)
Selpercatinib - Treatment A (TRT A)
EXPERIMENTAL160 milligram (mg) Selpercatinib administered orally twice daily (BID) continuously in 21-day cycles.
Pemetrexed and Platinum with or without Pembrolizumab - (TRT B)
ACTIVE COMPARATORPemetrexed 500 milligrams per meter squared (mg/m2) administered intravenously (IV) on Day 1, every 3 weeks (Q3W), plus investigator's choice of carboplatin area under the concentration versus time curve 5 (AUC 5 \[maximum dose of 750 mg\] IV), or cisplatin (75 mg/m2 cisplatin IV) on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- History of interstitial lung disease or interstitial pneumonitis.
- Active autoimmune disease or any illness or treatment that could compromise the immune system.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Loxo Oncology, Inc.collaborator
Study Sites (196)
Centro de Oncología e Investigación de Buenos Aires
Berazategui, Buenos Aires, B1884BBF, Argentina
Fundacion CENIT para la Investigacion en Neurociencias
Caba, Buenos Aires, 1125, Argentina
Clinica Viedma
Viedma, Río Negro Province, R8500ACE, Argentina
Alexander Fleming
Ciudad de Buenos Aires, C1426ANZ, Argentina
Clínica El Castaño
San Juan, 5400, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
St Vincent's Hospital
Melbourne, Victoria, 3065, Australia
Peninsula Oncology Centre
Frankston, 3199, Australia
UZ Brussel
Brussels, Bruxelles-Capitale, Région de, 1090, Belgium
AZ Nikolaas
Sint-Niklaas, Oost-Vlaanderen, B-9100, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
AZ Delta
Roeselare, West Flanders, 8800, Belgium
UZ Gent Hospital
Ghent, 9000, Belgium
AZ Sint-Maarten, Campus Leopoldstraat 2
Mechelen, 2800, Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, 5000, Belgium
Hospital Sírio Libanês
São Paulo, Brazil, 01308-060, Brazil
Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-070, Brazil
Hospital de Cancer de Londrina
Londrina, Paraná, 86015-520, Brazil
Grupo COI - Clínicas Oncológicas Integradas
Rio de Janeiro, Rio de Janeiro, 22775-001, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, São Paulo, 04543-000, Brazil
Instituto Nacional de Câncer - INCA
Rio de Janeiro, 20231-050, Brazil
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, 22250-905, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246000, Brazil
Hospital Sírio Libanês
São Paulo, 01308-060, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
First affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
The First Affiated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangzhou, 510120, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Xinjiang Medical University Cancer Hospital - Urumqi
Ürümqi, Xinjiang, 830000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, 310003, China
Shanghai Chest Hospital
Shanghai, 200030, China
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava - Vitkovice, 70384, Czechia
Fakultni nemocnice Bulovka
Prague, 180 81, Czechia
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69373, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, Bouches-du-Rhône, 13385, France
Institut Régional du Cancer Montpellier
Montpellier, Hérault, 34298, France
Chu Grenoble Alpes
La Tronche, Isère, 38700, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, Puy-de-Dôme, 63011, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75014, France
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, 69126, Germany
Asklepios Fachkliniken München-Gauting
Gauting, Bavaria, 82131, Germany
Klinikverbund Kempten-Oberallgäu
Immenstadt im Allgäu, Bavaria, 87509, Germany
Franziskus-Hospital Harderberg
Georgsmarienhütte, Lower Saxony, 49124, Germany
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075, Germany
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937, Germany
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, 22927, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, 12203, Germany
Sotiria Thoracic Diseases Hospital of Athens
Athens, Attikí, 115 27, Greece
University General Hospital of Heraklion
Heraklion, Krítí, 711 10, Greece
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, 570 01, Greece
G. Papanikolaou General Hospital
Thessaloniki, Thessaloníki, 570 10, Greece
Hong Kong United Oncology Centre
Jordan, Kowloon, 999077, Hong Kong
Prince of Wales Hospital
Shatin, 852, Hong Kong
Soroka Medical Center
Beersheba, 8400000, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Rambam Health Care Campus
Haifa, Ḥeifā, 3109601, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, Campania, 80131, Italy
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna, 48121, Italy
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00152, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
Ospedale San Gerardo-ASST Monza
Monza, Lombardy, 20900, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, 20162, Italy
Humanitas
Rozzano, Milano, 20089, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Torino, 10043, Italy
Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100, Italy
IRCCS - AOU di Bologna
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126, Italy
Istituto Nazionale Tumori Regina Elena
Roma, 00144, Italy
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kanagawa cancer center
Yokohama, Kanagawa, 241-8515, Japan
Kindai University Hospital- Osakasayama Campus
Osaka Sayama-shi, Osaka, 589 8511, Japan
Tominaga Hospital
Nakatogari, Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550, Japan
Tottori University Hospital
Yonago, Tottori, 683-8504, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Health Pharma Professional Research S.A. de C.V:
Mexico City, Federal District, 03100, Mexico
Actualidad Basada en la Investigación del Cáncer
Guadalajara, Jalisco, 44680, Mexico
Oncologico Potosino, S.C.
San Luis Potosí City, 78209, Mexico
Ziekenhuis St. Jansdal
Harderwijk, Gelderland, 3844 DG, Netherlands
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, 3015 CE, Netherlands
Amsterdam UMC, locatie VUmc
Amsterdam, 1081 HV, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Gral Medical Diagnostic Center
Bucharest, București, 031422, Romania
Institutul Oncologic
Bucharest, București, 22328, Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, Constanța County, 900591, Romania
Cabinet Medical Oncomed
Timișoara, Timiș County, 300239, Romania
Spitalul Universitar de Urgență București
Bucharest, 050098, Romania
Institutul Oncologic
Cluj-Napoca, 400015, Romania
Spitalul Județean Sfântul Ioan cel Nou Suceava
Suceava, 720237, Romania
GBUZ Republican Clinical Oncological Dispensary
Ufa, Baškortostan, Respublika, 450054, Russia
Kaluga Regional Clinical Oncology Center
Kaluga, Kalužskaja Oblast, 248007, Russia
Murmansk Regional Clinical Hospital P.A. Bayandina
Murmansk, Murmansk Oblast, 183047, Russia
Samara Regional Clinical Oncology Center
Samara, Samara Oblast, 443031, Russia
Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (oncological) named afte -T
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Scientific research institution of oncology named after N.N. Petrov
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, 163045, Russia
Republican Clinical Oncology Dispensary
Kazan', 420029, Russia
First Moscow State Medical University I.M. Sechenov
Moscow, 119991, Russia
Hadassah Medical
Moscow, 121205, Russia
Tan Tock Seng Hospital
Singapore, 308433, Singapore
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Gachon University Gil Medical Center
Incheon, Korea, 21565, South Korea
Asan Medical Center
Seoul, Korea, 05505, South Korea
Gyeongsang National University Hospital
Jinju, Kyǒngsangnam-do, 52727, South Korea
Seoul National University Hospital
Seoul, Seoul, Korea, 03080, South Korea
Boramae Medical Center
Dongjak-gu, Seoul-teukbyeolsi [Seoul], 07061, South Korea
Konyang University Hospital
Daejeon, 35365, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Fundacion Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [Barcelona], 08916, Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, Galicia [Galicia], 15706, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Clinica Universitaria De Navarra
Pamplona, Navarre, 31008, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Dexeus
Barcelona, 08028, Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Regional Universitario
Málaga, 29011, Spain
Complejo Hospitalario de Navarra
Pamplona, 31009, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Changhua Christian Hospital
Changhua County, Changhua, 50006, Taiwan
Buddhist Dalin Tzu Chi General Hospital
Dalin Town, Chiayi, 622, Taiwan
Chang Gung Memorial Hospital - Linkou
Guei Shan Township, Taoyuan County, 333, Taiwan
E-Da hospital
Kaohsiung City, 82445, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 83301, Taiwan
Tri-Service General Hospital
Neihu Taipei, 114, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng-Kung Uni. Hosp.
Tainan, 704, Taiwan
Chi Mei Hospital - Liouying Branch
Tainan, 73657, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Ege Universitesi Hastanesi
Bornova, İzmir, 35100, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, 1250, Turkey (Türkiye)
Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
Ankara, 6200, Turkey (Türkiye)
Hacettepe University Faculty of Medicine
Ankara, 6230, Turkey (Türkiye)
Memorial Antalya Hastanesi
Antalya, 7090, Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, 21100, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
Istanbul Medeniyet University
Istanbul, 34722, Turkey (Türkiye)
zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi
Izmir, 35360, Turkey (Türkiye)
Izmir Medical Park Hospital
Izmir, 9035575, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tıp Merkezi
Malatya, 44280, Turkey (Türkiye)
Acıbadem Maslak Hastanesi
Sarıyer, 34457, Turkey (Türkiye)
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Medical University"
Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine
CNPE "Regional Center of Oncology"
Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine
Odessa Regional Oncology Center
Odesa, Odesa Oblast, 65055, Ukraine
Sumy regional clinical oncological dispensary
Sumy, Sumska Oblast, 40022, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
Vinnytsia, Vinnytsia Oblast, 21029, Ukraine
Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
Lutsk, Volyn Oblast, 43018, Ukraine
"Oncolife" LLC
Zaporizhya, Zaporizhzhia Oblast, 69059, Ukraine
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center"
Chernivtsi, 58013, Ukraine
Medical Center "Mriya Med-Service", LLC
Kryvyi Rig, 50000, Ukraine
Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Counci -T
Kyiv, 03115, Ukraine
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
Odesa, 65025, Ukraine
City Hospital, Nottingham University Hospitals
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Related Publications (4)
Perol M, Solomon BJ, Goto K, Park K, Nadal E, Bria E, Martin C, Bar J, Williams JN, Puri T, Li J, Uh MK, Lin BK, Zhou C. CNS Protective Effect of Selpercatinib in First-Line RET Fusion-Positive Advanced Non-Small Cell Lung Cancer. J Clin Oncol. 2024 Jul 20;42(21):2500-2505. doi: 10.1200/JCO.24.00724. Epub 2024 Jun 3.
PMID: 38828957DERIVEDZhou C, Solomon B, Loong HH, Park K, Perol M, Arriola E, Novello S, Han B, Zhou J, Ardizzoni A, Mak MP, Santini FC, Elamin YY, Drilon A, Wolf J, Payakachat N, Uh MK, Rajakumar D, Han H, Puri T, Soldatenkova V, Lin AB, Lin BK, Goto K; LIBRETTO-431 Trial Investigators. First-Line Selpercatinib or Chemotherapy and Pembrolizumab in RET Fusion-Positive NSCLC. N Engl J Med. 2023 Nov 16;389(20):1839-1850. doi: 10.1056/NEJMoa2309457. Epub 2023 Oct 21.
PMID: 37870973DERIVEDClaerhout 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.
PMID: 35378489DERIVEDSolomon 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.
PMID: 33150799DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2019
First Posted
December 11, 2019
Study Start
February 17, 2020
Primary Completion
May 1, 2023
Study Completion (Estimated)
June 1, 2030
Last Updated
October 21, 2025
Results First Posted
June 20, 2024
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.