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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Selpercatinib
Carboplatin
Cisplatin
Pemetrexed
Pembrolizumab
Sponsored by
Loxo Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring targeted therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Oncología e Investigación de Buenos Aires
  • Fundacion CENIT para la Investigacion en Neurociencias
  • Clinica Viedma S. A
  • Instituto Alexander Fleming
  • Clínica El Castaño
  • Chris O'Brien Lifehouse
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Monash Medical Centre
  • Peter MacCallum Cancer Centre
  • St Vincent's Hospital
  • Peninsula & South Eastern Haematology and Oncology Group
  • ZNA Middelheim
  • Universitair Ziekenhuis Brussel
  • AZ Delta
  • UZ Gent Hospital
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • AZ Sint-Maarten, Campus Leopoldstraat 2
  • CHU UCL Namur/Site Sainte Elisabeth
  • VITAZ
  • Núcleo de Oncologia da Bahia
  • Hospital de Cancer de Londrina
  • Hospital São Lucas da PUCRS
  • Instituto de Educação, Pesquisa e Gestão em Saúde
  • Fundação Pio XII - Hospital de Câncer de Barretos
  • Clinica Onco Star
  • INCA Hospital do Câncer III
  • Oncoclinicas Rio de Janeiro S.A.
  • Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology
  • Icesp - Instituto Do Câncer Do Estado de São Paulo
  • Centro Paulista de Oncologia
  • Cross Cancer Institute
  • Princess Margaret Hospital (Ontario)
  • Beijing Cancer hospital
  • First affiliated Hospital of Sun Yat-Sen University
  • The First Affiated Hospital Of Guangzhou Medical Collage
  • Harbin Medical University Cancer Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan Cancer Hospital
  • Changzhou No.2 People's Hospital
  • Jilin Cancer Hospital
  • Shanghai Pulmonary Hospital
  • West China Hospital of Sichuan University
  • Xinjiang Medical University Cancer Hospital
  • Zhejiang Cancer Hospital
  • People's Hospital of Hunan Province
  • First Affiliated Hosp of College of Med, Zhejiang University
  • Shanghai Chest Hospital
  • Fakultni nemocnice Olomouc
  • Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni
  • Fakultni nemocnice Bulovka
  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
  • Centre Leon Berard
  • CHU Grenoble Alpes- Hopital Albert Michallon
  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
  • Institut du Cancer de Montpellier - Val d'aurelle
  • Hopital Cochin
  • Thoraxklinik-Heidelberg gGmbH
  • Asklepios Fachkliniken München-Gauting
  • Klinikverbund Kempten-Oberallgäu
  • Franziskus-Hospital Harderberg
  • Universitätsmedizin Göttingen
  • Universitätsklinikum Köln
  • LungenClinic Grosshansdorf
  • Charité Campus Virchow-Klinikum
  • Sotiria Thoracic Diseases Hospital of Athens
  • University General Hospital of Heraklion
  • European Interbalkan Medical Center
  • G. Papanikolaou General Hospital
  • Hong Kong United Oncology Centre
  • Prince of Wales Hospital
  • Soroka Medical Center - Pediatric Outpatient Clinic
  • Rambam Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Medical Center
  • Sheba Medical Center
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Azienda Ospedaliera San Camillo Forlanini
  • Policlinico Gemelli - Università Cattolica del Sacro Cuore
  • ASST Grande Ospedale Metropolitano Niguarda
  • Azienda Ospedaliera San Gerardo
  • Istituto Clinico Humanitas
  • Centro di Riferimento Oncologico
  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
  • Ospedale G. Moscati
  • IRCCS - AOU di Bologna
  • Azienda Ospedlaliero-Univeristaria Pisana, Stabilimento Ospedaliero di Cisanello
  • Ospedale Santa Maria delle Croci
  • I.F.O. Istituto Nazionale Tumori Regina Elena
  • National Cancer Center Hospital East
  • Hokkaido University Hospital
  • Kanazawa University Hospital
  • Kanagawa cancer center
  • Kindai University Hospital
  • Shizuoka Cancer Center
  • National Cancer Center Hospital
  • Japanese Foundation for Cancer Research
  • Tottori University Hospital
  • Okayama University Hospital
  • Osaka International Cancer Institute
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Gyeongsang National University Hospital
  • Gachon University Gil Medical Center
  • Asan Medical Center
  • Seoul National University Hospital
  • Konyang University Hospital
  • Samsung Medical Center
  • Seoul Municipal Boramae Hospital
  • Health Pharma Professional Research S.A. de C.V:
  • Actualidad Basada en la Investigación del Cáncer
  • Oncologico Potosino, S.C.
  • Ziekenhuis St. Jansdal
  • Jeroen Bosch Hospital
  • Vrije Universiteit Medisch Centrum Amsterdam
  • Erasmus Medisch Centrum
  • Uniwersyteckie Centrum Kliniczne
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
  • Institutul Oncologic
  • Gral Medical SRL
  • Cabinet Medical Oncomed
  • Spitalul Universitar de Urgență București
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
  • Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
  • Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"
  • GBUZ Republican Clinical Oncological Dispensary
  • SHI Kaluga Regional Hospital
  • Samara Regional Clinical Oncology Center
  • N.N.Petrov Research Institute of Oncology
  • Arkhangelsk Clinical Oncological Dispensary
  • Republic Oncology Dispensary of MoH of Republic Tatarstan
  • First Moscow State Medical University n.a. Sechenov
  • Hadassah Medical LTD
  • Murmansk Regional Clinical Hospital
  • St-Petersburg scientifical practical cente spec medical care
  • Tan Tock Seng Hospital
  • Hospital Fundacion Son Llatzer
  • Institut Català d'Oncologia (ICO) - Badalona
  • CHUS - Hospital Clinico Universitario
  • Hospital Insular de Gran Canaria
  • Hospital Puerta De Hierro
  • Clinica Universitaria De Navarra
  • Hospital General Universitario de Alicante
  • Hospital del Mar
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari Dexeus
  • Institut Catala d'Oncologia
  • Complejo Hospitalario de Jaén
  • Hospital Universitario Ramón y Cajal
  • Hospital Clinico San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Regional Universitario
  • Hospital De Navarra
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen Del Rocio
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario La Fe de Valencia
  • Changhua Christian Hospital
  • Buddhist Dalin Tzu Chi General Hospital
  • Chang Gung Memorial Hospital - Linkou
  • E-Da hospital
  • Chang Gung Memorial Hospital - Kaohsiung Branch
  • Tri-Service General Hospital
  • Taipei Medical University Shuang Ho Hospital
  • Chung Shan Medical University Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • Chi Mei Hospital - Liouying Branch
  • National Cheng-Kung Uni. Hosp.
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Ege University Medicine of Faculty
  • Baskent University Dr. Turgut Noyan Research and Training Center
  • Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
  • Hacettepe University Faculty of Medicine
  • Dicle Üniversitesi
  • Trakya University
  • Istanbul Medeniyet University
  • Izmir Ataturk Training and Research Hospital
  • I.E.U. Medical Point Hastanesi
  • Memorial Antalya Hastanesi
  • Inonu Universitesi Turgut Ozal Tıp Merkezi
  • Maslak Acıbadem Hstanesi
  • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Medical University"
  • CNPE "Regional Center of Oncology"
  • Sumy regional clinical oncological dispensary
  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
  • Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
  • Chernivtsi Regional Oncological Dispensary
  • Medical Center "Mriya Med-Service", LLC
  • Kyiv City Clinical Oncological Center
  • Odessa Regional Oncology Dispensary
  • CI Odesa Regional Clinical Hospital
  • Medical center "Oncolife"
  • City Hospital, Nottingham University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Selpercatinib

Pemetrexed with or without Pembrolizumab

Pemetrexed with Pembrolizumab

Arm Description

Selpercatinib administered orally.

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

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

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (with Pembrolizumab)
PFS by BICR (with Pembrolizumab)
PFS by BICR (with or without Pembrolizumab)
PFS by BICR (with or without Pembrolizumab)

Secondary Outcome Measures

Disease Control Rate (DCR) by BICR (with Pembrolizumab)
DCR by BICR (with Pembrolizumab)
DCR by BICR (with or without Pembrolizumab)
DCR by BICR (with or without Pembrolizumab)
PFS2 (with Pembrolizumab)
PFS2 (with Pembrolizumab)
PFS2 (with or without Pembrolizumab)
PFS2 (with or without Pembrolizumab)
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR (with Pembrolizumab)
ORR: Percentage of Participants with CR or PR by BICR (with Pembrolizumab)
ORR: Percentage of Participants with CR or PR by BICR (with or without Pembrolizumab)
ORR: Percentage of Participants with CR or PR by BICR (with or without Pembrolizumab)
Duration of Response (DoR) by BICR (with Pembrolizumab)
DOR by BICR (with Pembrolizumab)
DOR by BICR (with or without Pembrolizumab)
DOR by BICR (with or without Pembrolizumab)
Overall Survival (OS) (with Pembrolizumab)
OS (with Pembrolizumab)
OS (with or without Pembrolizumab)
OS (with or without Pembrolizumab)
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (with Pembrolizumab)
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab)
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab)
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab)
Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)
Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)
Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab)
Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab)
Time to Deterioration of Pulmonary Symptoms (with Pembrolizumab)
Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) (with Pembrolizumab)
Time to Deterioration of Pulmonary Symptoms (with or without Pembrolizumab)
Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-SAQ (with or without Pembrolizumab)
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)
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)
Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab)
Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab)
Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab)
Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab)
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (with Pembrolizumab)
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with Pembrolizumab)
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab)
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab)
Intracranial DOR per RANO-BM by BICR (with Pembrolizumab)
Intracranial DOR per RANO-BM by BICR (with Pembrolizumab)
Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab)
Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab)

Full Information

First Posted
December 9, 2019
Last Updated
October 20, 2023
Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04194944
Brief Title
A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Acronym
LIBRETTO-431
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
February 18, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
targeted therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Selpercatinib
Arm Type
Experimental
Arm Description
Selpercatinib administered orally.
Arm Title
Pemetrexed with or without Pembrolizumab
Arm Type
Active Comparator
Arm Description
Pemetrexed administered intravenously (IV) plus the investigator's discretion of carboplatin IV or cisplatin IV with or without pembrolizumab IV.
Arm Title
Pemetrexed with Pembrolizumab
Arm Type
Active Comparator
Arm Description
Pemetrexed administered IV plus the investigator's discretion of carboplatin IV or cisplatin IV with pembrolizumab IV.
Intervention Type
Drug
Intervention Name(s)
Selpercatinib
Other Intervention Name(s)
LY3527723, LOXO-292
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (with Pembrolizumab)
Description
PFS by BICR (with Pembrolizumab)
Time Frame
Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)
Title
PFS by BICR (with or without Pembrolizumab)
Description
PFS by BICR (with or without Pembrolizumab)
Time Frame
Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR) by BICR (with Pembrolizumab)
Description
DCR by BICR (with Pembrolizumab)
Time Frame
Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)
Title
DCR by BICR (with or without Pembrolizumab)
Description
DCR by BICR (with or without Pembrolizumab)
Time Frame
Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)
Title
PFS2 (with Pembrolizumab)
Description
PFS2 (with Pembrolizumab)
Time Frame
Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months)
Title
PFS2 (with or without Pembrolizumab)
Description
PFS2 (with or without Pembrolizumab)
Time Frame
Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months)
Title
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR (with Pembrolizumab)
Description
ORR: Percentage of Participants with CR or PR by BICR (with Pembrolizumab)
Time Frame
Baseline through Disease Progression or Death (Estimated at up to 24 Months)
Title
ORR: Percentage of Participants with CR or PR by BICR (with or without Pembrolizumab)
Description
ORR: Percentage of Participants with CR or PR by BICR (with or without Pembrolizumab)
Time Frame
Baseline through Disease Progression or Death (Estimated at up to 24 Months)
Title
Duration of Response (DoR) by BICR (with Pembrolizumab)
Description
DOR by BICR (with Pembrolizumab)
Time Frame
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 24 Months)
Title
DOR by BICR (with or without Pembrolizumab)
Description
DOR by BICR (with or without Pembrolizumab)
Time Frame
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 24 Months)
Title
Overall Survival (OS) (with Pembrolizumab)
Description
OS (with Pembrolizumab)
Time Frame
Baseline to Date of Death from Any Cause (Estimated at up to 48 Months)
Title
OS (with or without Pembrolizumab)
Description
OS (with or without Pembrolizumab)
Time Frame
Baseline to Date of Death from Any Cause (Estimated at up to 48 Months)
Title
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (with Pembrolizumab)
Description
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab)
Time Frame
Baseline through Central Nervous System (CNS) Progression or Death (Estimated at up to 24 Months)
Title
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab)
Description
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab)
Time Frame
Baseline through CNS Progression or Death (Estimated at up to 24 Months)
Title
Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)
Description
Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)
Time Frame
Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)
Title
Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab)
Description
Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab)
Time Frame
Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)
Title
Time to Deterioration of Pulmonary Symptoms (with Pembrolizumab)
Description
Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) (with Pembrolizumab)
Time Frame
Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 Months)
Title
Time to Deterioration of Pulmonary Symptoms (with or without Pembrolizumab)
Description
Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-SAQ (with or without Pembrolizumab)
Time Frame
Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 Months)
Title
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)
Description
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)
Time Frame
Baseline
Title
Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab)
Description
Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab)
Time Frame
Baseline through CNS Progression or Death (Estimated at up to 24 Months)
Title
Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab)
Description
Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab)
Time Frame
Baseline through CNS Progression or Death (Estimated at up to 24 Months)
Title
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (with Pembrolizumab)
Description
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with Pembrolizumab)
Time Frame
Baseline through CNS Progression or Death (Estimated at up to 24 Months)
Title
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab)
Description
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab)
Time Frame
Baseline through CNS Progression or Death (Estimated at up to 24 Months)
Title
Intracranial DOR per RANO-BM by BICR (with Pembrolizumab)
Description
Intracranial DOR per RANO-BM by BICR (with Pembrolizumab)
Time Frame
Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)
Title
Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab)
Description
Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab)
Time Frame
Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Oncología e Investigación de Buenos Aires
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
Fundacion CENIT para la Investigacion en Neurociencias
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Clinica Viedma S. A
City
Viedma
State/Province
Río Negro
ZIP/Postal Code
R8500ACE
Country
Argentina
Facility Name
Instituto Alexander Fleming
City
Ciudad de Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Clínica El Castaño
City
San Juan
ZIP/Postal Code
J5400ARW
Country
Argentina
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
St Vincent's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Peninsula & South Eastern Haematology and Oncology Group
City
Frankston
ZIP/Postal Code
3199
Country
Australia
Facility Name
ZNA Middelheim
City
Antwerp
State/Province
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
State/Province
West Flanders
ZIP/Postal Code
8800
Country
Belgium
Facility Name
UZ Gent Hospital
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Maarten, Campus Leopoldstraat 2
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
CHU UCL Namur/Site Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
VITAZ
City
Sint Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Núcleo de Oncologia da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41170-110
Country
Brazil
Facility Name
Hospital de Cancer de Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86015-520
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Instituto de Educação, Pesquisa e Gestão em Saúde
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Clinica Onco Star
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04501-000
Country
Brazil
Facility Name
INCA Hospital do Câncer III
City
Rio de Janeiro
ZIP/Postal Code
20231
Country
Brazil
Facility Name
Oncoclinicas Rio de Janeiro S.A.
City
Rio de Janeiro
ZIP/Postal Code
22250-905
Country
Brazil
Facility Name
Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology
City
Sao Paolo
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Icesp - Instituto Do Câncer Do Estado de São Paulo
City
Sao Paulo
ZIP/Postal Code
01246000
Country
Brazil
Facility Name
Centro Paulista de Oncologia
City
São Paulo
ZIP/Postal Code
04538-133
Country
Brazil
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Princess Margaret Hospital (Ontario)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Beijing Cancer hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
First affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiated Hospital Of Guangzhou Medical Collage
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
West China Hospital of Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Xinjiang Medical University Cancer Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
People's Hospital of Hunan Province
City
Changsha
ZIP/Postal Code
410002
Country
China
Facility Name
First Affiliated Hosp of College of Med, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni
City
Ostrava - Vitkovice
ZIP/Postal Code
70384
Country
Czechia
Facility Name
Fakultni nemocnice Bulovka
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Leon Berard
City
Lyon
State/Province
Rhône-Alpes
ZIP/Postal Code
69008
Country
France
Facility Name
CHU Grenoble Alpes- Hopital Albert Michallon
City
Cs10217 Grenoble Cedex 9
ZIP/Postal Code
38049
Country
France
Facility Name
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Institut du Cancer de Montpellier - Val d'aurelle
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Thoraxklinik-Heidelberg gGmbH
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Asklepios Fachkliniken München-Gauting
City
Gauting
State/Province
Bayern
ZIP/Postal Code
82131
Country
Germany
Facility Name
Klinikverbund Kempten-Oberallgäu
City
Immenstadt
State/Province
Bayern
ZIP/Postal Code
87509
Country
Germany
Facility Name
Franziskus-Hospital Harderberg
City
Georgsmarienhütte
State/Province
Niedersachsen
ZIP/Postal Code
49124
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
LungenClinic Grosshansdorf
City
Grosshansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Sotiria Thoracic Diseases Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 27
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
State/Province
Krítí
ZIP/Postal Code
711 10
Country
Greece
Facility Name
European Interbalkan Medical Center
City
Thessaloniki
State/Province
Thessaloníki
ZIP/Postal Code
570 01
Country
Greece
Facility Name
G. Papanikolaou General Hospital
City
Thessaloniki
State/Province
Thessaloníki
ZIP/Postal Code
570 10
Country
Greece
Facility Name
Hong Kong United Oncology Centre
City
Jordan
State/Province
Kowloon
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
ZIP/Postal Code
852
Country
Hong Kong
Facility Name
Soroka Medical Center - Pediatric Outpatient Clinic
City
Beer-Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Policlinico Gemelli - Università Cattolica del Sacro Cuore
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milan
State/Province
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
State/Province
Milano
ZIP/Postal Code
20052
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Centro di Riferimento Oncologico
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Ospedale G. Moscati
City
Avellino
ZIP/Postal Code
50019
Country
Italy
Facility Name
IRCCS - AOU di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedlaliero-Univeristaria Pisana, Stabilimento Ospedaliero di Cisanello
City
Pisa
ZIP/Postal Code
56125
Country
Italy
Facility Name
Ospedale Santa Maria delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
I.F.O. Istituto Nazionale Tumori Regina Elena
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanagawa cancer center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka Sayama-shi
State/Province
Osaka
ZIP/Postal Code
589 8511
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Japanese Foundation for Cancer Research
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Tottori University Hospital
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Jin-ju-si
State/Province
Gyeongsangnam-do
ZIP/Postal Code
52727
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Korea
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul, Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejon
ZIP/Postal Code
35365
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul Municipal Boramae Hospital
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Health Pharma Professional Research S.A. de C.V:
City
Mexico City
State/Province
Federal District
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Actualidad Basada en la Investigación del Cáncer
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44680
Country
Mexico
Facility Name
Oncologico Potosino, S.C.
City
San Luis Potosí
ZIP/Postal Code
78209
Country
Mexico
Facility Name
Ziekenhuis St. Jansdal
City
Harderwijk
State/Province
Gelderland
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Jeroen Bosch Hospital
City
Den Bosch
State/Province
Noord-Brabant
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum Amsterdam
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Institutul Oncologic
City
Bucharest
State/Province
București
ZIP/Postal Code
22328
Country
Romania
Facility Name
Gral Medical SRL
City
Bucuresti
State/Province
București
ZIP/Postal Code
031422
Country
Romania
Facility Name
Cabinet Medical Oncomed
City
Timișoara
State/Province
Timiș
ZIP/Postal Code
300239
Country
Romania
Facility Name
Spitalul Universitar de Urgență București
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou"
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
GBUZ Republican Clinical Oncological Dispensary
City
Ufa
State/Province
Baškortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
SHI Kaluga Regional Hospital
City
Kaluga
State/Province
Kalužskaja Oblast
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Samara Regional Clinical Oncology Center
City
Samara
State/Province
Samarskaya Oblast'
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
N.N.Petrov Research Institute of Oncology
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Arkhangelsk Clinical Oncological Dispensary
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Republic Oncology Dispensary of MoH of Republic Tatarstan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
First Moscow State Medical University n.a. Sechenov
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Hadassah Medical LTD
City
Moscow
ZIP/Postal Code
121205
Country
Russian Federation
Facility Name
Murmansk Regional Clinical Hospital
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
St-Petersburg scientifical practical cente spec medical care
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hospital Fundacion Son Llatzer
City
Palma de Mallorca
State/Province
Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Institut Català d'Oncologia (ICO) - Badalona
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
Galicia [Galicia]
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Insular de Gran Canaria
City
Las palmas de gran canaria
State/Province
Las Palmas
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Puerta De Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Clinica Universitaria De Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Institut Catala d'Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Complejo Hospitalario de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional Universitario
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital De Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Changhua Christian Hospital
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Buddhist Dalin Tzu Chi General Hospital
City
Dalin Town
State/Province
Chiayi
ZIP/Postal Code
62247
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Guei Shan Township
State/Province
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
E-Da hospital
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Neihu Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705, ROC
Country
Taiwan
Facility Name
Chi Mei Hospital - Liouying Branch
City
Tainan City
ZIP/Postal Code
736
Country
Taiwan
Facility Name
National Cheng-Kung Uni. Hosp.
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Ege University Medicine of Faculty
City
Bornova
State/Province
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Baskent University Dr. Turgut Noyan Research and Training Center
City
Adana
ZIP/Postal Code
1250
Country
Turkey
Facility Name
Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Hacettepe University Faculty of Medicine
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Dicle Üniversitesi
City
Diyarbakir
ZIP/Postal Code
21100
Country
Turkey
Facility Name
Trakya University
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul Medeniyet University
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey
Facility Name
Izmir Ataturk Training and Research Hospital
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Facility Name
I.E.U. Medical Point Hastanesi
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Facility Name
Memorial Antalya Hastanesi
City
Kepez
ZIP/Postal Code
07020
Country
Turkey
Facility Name
Inonu Universitesi Turgut Ozal Tıp Merkezi
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Maslak Acıbadem Hstanesi
City
Sarıyer
ZIP/Postal Code
34457
Country
Turkey
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Medical University"
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
CNPE "Regional Center of Oncology"
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Sumy regional clinical oncological dispensary
City
Sumy
State/Province
Sumska Oblast
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
City
Lutsk
State/Province
Volynska Oblast
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Chernivtsi Regional Oncological Dispensary
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Medical Center "Mriya Med-Service", LLC
City
Kryvyi Rig
ZIP/Postal Code
50019
Country
Ukraine
Facility Name
Kyiv City Clinical Oncological Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Odessa Regional Oncology Dispensary
City
Odesa
ZIP/Postal Code
65000
Country
Ukraine
Facility Name
CI Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Medical center "Oncolife"
City
Zaporizhya
ZIP/Postal Code
69000
Country
Ukraine
Facility Name
City Hospital, Nottingham University Hospitals
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Citations:
PubMed Identifier
35378489
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.
Results Reference
derived
PubMed Identifier
33150799
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.
Results Reference
derived
Links:
URL
https://trials.lilly.com/en-US/trial/230195
Description
A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Learn more about this trial

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

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