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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04194944




Registration number
NCT04194944
Ethics application status
Date submitted
9/12/2019
Date registered
11/12/2019

Titles & IDs
Public title
A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
J2G-MC-JZJC
Secondary ID [2] 0 0
17479
Universal Trial Number (UTN)
Trial acronym
LIBRETTO-431
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Selpercatinib
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Pembrolizumab

Experimental: Selpercatinib - Treatment A (TRT A) - 160 milligram (mg) Selpercatinib administered orally twice daily (BID) continuously in 21-day cycles.

Active comparator: Pemetrexed and Platinum with or without Pembrolizumab - (TRT B) - Pemetrexed 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.


Treatment: Drugs: Selpercatinib
Administered orally

Treatment: Drugs: Carboplatin
Administered IV

Treatment: Drugs: Cisplatin
Administered IV

Treatment: Drugs: Pemetrexed
Administered IV

Treatment: Drugs: Pembrolizumab
Administered IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab)
Timepoint [1] 0 0
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
Primary outcome [2] 0 0
PFS by BICR (With or Without Pembrolizumab)
Timepoint [2] 0 0
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
Secondary outcome [1] 0 0
Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab)
Timepoint [1] 0 0
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
Secondary outcome [2] 0 0
Percentage of Participant With DCR by BICR (With or Without Pembrolizumab)
Timepoint [2] 0 0
Baseline to Progressive Disease or Death from Any Cause Up to 31 Months
Secondary outcome [3] 0 0
PFS2 (With Pembrolizumab)
Timepoint [3] 0 0
Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months
Secondary outcome [4] 0 0
PFS2 (With or Without Pembrolizumab)
Timepoint [4] 0 0
Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months
Secondary outcome [5] 0 0
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab)
Timepoint [5] 0 0
Baseline through Disease Progression or Death Up to 31 Months
Secondary outcome [6] 0 0
ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab)
Timepoint [6] 0 0
Baseline through Disease Progression or Death Up to 31 Months
Secondary outcome [7] 0 0
Duration of Response (DoR) by BICR (With Pembrolizumab)
Timepoint [7] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months
Secondary outcome [8] 0 0
DOR by BICR (With or Without Pembrolizumab)
Timepoint [8] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months
Secondary outcome [9] 0 0
Overall Survival (OS) (With Pembrolizumab)
Timepoint [9] 0 0
Baseline to Date of Death from Any Cause Up to 38 Months
Secondary outcome [10] 0 0
OS (With or Without Pembrolizumab)
Timepoint [10] 0 0
Baseline to Date of Death from Any Cause Up to 38 Months
Secondary outcome [11] 0 0
Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (With Pembrolizumab)
Timepoint [11] 0 0
Baseline through Central Nervous System (CNS) Progression or Death up to 31 Months
Secondary outcome [12] 0 0
Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST 1.1 by BICR (With or Without Pembrolizumab)
Timepoint [12] 0 0
Baseline through CNS Progression or Death Up to 31 Months
Secondary outcome [13] 0 0
Median Intracranial DOR Per RECIST 1.1 by BICR (With Pembrolizumab)
Timepoint [13] 0 0
Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months
Secondary outcome [14] 0 0
Median Intracranial DOR Per RECIST 1.1 by BICR (With or Without Pembrolizumab)
Timepoint [14] 0 0
Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months
Secondary outcome [15] 0 0
Time to Deterioration of Pulmonary Symptoms (With Pembrolizumab)
Timepoint [15] 0 0
Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months
Secondary outcome [16] 0 0
Time to Deterioration of Pulmonary Symptoms (With or Without Pembrolizumab)
Timepoint [16] 0 0
Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months
Secondary outcome [17] 0 0
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)
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
Median Time to CNS Progression Per RECIST 1.1 by BICR (With Pembrolizumab)
Timepoint [18] 0 0
Baseline through CNS Progression or Death Up to 31 Months
Secondary outcome [19] 0 0
Median Time to CNS Progression Per RECIST 1.1 by BICR (With or Without Pembrolizumab)
Timepoint [19] 0 0
Baseline through CNS Progression or Death Up to 31 Months
Secondary outcome [20] 0 0
Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (With Pembrolizumab)
Timepoint [20] 0 0
Baseline through CNS Progression or Death Up to 31 Months
Secondary outcome [21] 0 0
Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RANO-BM by BICR (With or Without Pembrolizumab)
Timepoint [21] 0 0
Baseline through CNS Progression or Death Up to 31 Months
Secondary outcome [22] 0 0
Intracranial DOR Per RANO-BM by BICR (With Pembrolizumab)
Timepoint [22] 0 0
Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months
Secondary outcome [23] 0 0
Intracranial DOR Per RANO-BM by BICR (With or Without Pembrolizumab)
Timepoint [23] 0 0
Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/06/2026
Actual
Sample size
Target
Accrual to date
Final
261
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [7] 0 0
Peninsula Oncology Centre - Frankston
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3065 - Melbourne
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Río Negro
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad de Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
San Juan
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles-Capitale, Région De
Country [6] 0 0
Belgium
State/province [6] 0 0
Oost-Vlaanderen
Country [7] 0 0
Belgium
State/province [7] 0 0
Vlaams-Brabant
Country [8] 0 0
Belgium
State/province [8] 0 0
West Flanders
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Belgium
State/province [10] 0 0
Mechelen
Country [11] 0 0
Belgium
State/province [11] 0 0
Namur
Country [12] 0 0
Brazil
State/province [12] 0 0
Bahia
Country [13] 0 0
Brazil
State/province [13] 0 0
Paraná
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio Grande Do Sul
Country [15] 0 0
Brazil
State/province [15] 0 0
RJ
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Brazil
State/province [17] 0 0
SP
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio de Janeiro
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paolo
Country [20] 0 0
Brazil
State/province [20] 0 0
São Paulo
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Guangdong
Country [25] 0 0
China
State/province [25] 0 0
Guangzhou
Country [26] 0 0
China
State/province [26] 0 0
Heilongjiang
Country [27] 0 0
China
State/province [27] 0 0
Hubei
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China
State/province [28] 0 0
Hunan
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China
State/province [29] 0 0
Jiangsu
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China
State/province [30] 0 0
Jilin
Country [31] 0 0
China
State/province [31] 0 0
Shanghai
Country [32] 0 0
China
State/province [32] 0 0
Sichuan
Country [33] 0 0
China
State/province [33] 0 0
Xinjiang
Country [34] 0 0
China
State/province [34] 0 0
Zhejiang
Country [35] 0 0
China
State/province [35] 0 0
Hangzhou
Country [36] 0 0
Czechia
State/province [36] 0 0
Olomouc
Country [37] 0 0
Czechia
State/province [37] 0 0
Ostrava - Vitkovice
Country [38] 0 0
Czechia
State/province [38] 0 0
Praha 8
Country [39] 0 0
France
State/province [39] 0 0
Bouches-du-Rhône
Country [40] 0 0
France
State/province [40] 0 0
Hérault
Country [41] 0 0
France
State/province [41] 0 0
Isère
Country [42] 0 0
France
State/province [42] 0 0
Puy-de-Dôme
Country [43] 0 0
France
State/province [43] 0 0
Rhône-Alpes
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France
State/province [44] 0 0
Paris
Country [45] 0 0
Germany
State/province [45] 0 0
Baden-Württemberg
Country [46] 0 0
Germany
State/province [46] 0 0
Bayern
Country [47] 0 0
Germany
State/province [47] 0 0
Niedersachsen
Country [48] 0 0
Germany
State/province [48] 0 0
Nordrhein-Westfalen
Country [49] 0 0
Germany
State/province [49] 0 0
Schleswig-Holstein
Country [50] 0 0
Germany
State/province [50] 0 0
Berlin
Country [51] 0 0
Greece
State/province [51] 0 0
Attikí
Country [52] 0 0
Greece
State/province [52] 0 0
Krítí
Country [53] 0 0
Greece
State/province [53] 0 0
Thessaloníki
Country [54] 0 0
Hong Kong
State/province [54] 0 0
Kowloon
Country [55] 0 0
Hong Kong
State/province [55] 0 0
Shatin
Country [56] 0 0
Israel
State/province [56] 0 0
Beer-Sheva
Country [57] 0 0
Israel
State/province [57] 0 0
Jerusalem
Country [58] 0 0
Israel
State/province [58] 0 0
Ramat Gan
Country [59] 0 0
Israel
State/province [59] 0 0
?eifa
Country [60] 0 0
Italy
State/province [60] 0 0
Campania
Country [61] 0 0
Italy
State/province [61] 0 0
Emilia-Romagna
Country [62] 0 0
Italy
State/province [62] 0 0
Friuli-Venezia Giulia
Country [63] 0 0
Italy
State/province [63] 0 0
Lazio
Country [64] 0 0
Italy
State/province [64] 0 0
Lombardia
Country [65] 0 0
Italy
State/province [65] 0 0
Milano
Country [66] 0 0
Italy
State/province [66] 0 0
Torino
Country [67] 0 0
Italy
State/province [67] 0 0
Avellino
Country [68] 0 0
Italy
State/province [68] 0 0
Bologna
Country [69] 0 0
Italy
State/province [69] 0 0
Pisa
Country [70] 0 0
Italy
State/province [70] 0 0
Roma
Country [71] 0 0
Japan
State/province [71] 0 0
Chiba
Country [72] 0 0
Japan
State/province [72] 0 0
Hokkaido
Country [73] 0 0
Japan
State/province [73] 0 0
Ishikawa
Country [74] 0 0
Japan
State/province [74] 0 0
Kanagawa
Country [75] 0 0
Japan
State/province [75] 0 0
Osaka
Country [76] 0 0
Japan
State/province [76] 0 0
Shizuoka
Country [77] 0 0
Japan
State/province [77] 0 0
Tokyo
Country [78] 0 0
Japan
State/province [78] 0 0
Tottori
Country [79] 0 0
Japan
State/province [79] 0 0
Okayama
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Gyeonggi-do
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Korea
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Kyongsangnam-do
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Korea, Republic of
State/province [83] 0 0
Seoul, Korea
Country [84] 0 0
Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Daejon
Country [86] 0 0
Korea, Republic of
State/province [86] 0 0
Seoul
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Mexico
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Federal District
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Mexico
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Jalisco
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Mexico
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San Luis Potosí
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Netherlands
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Gelderland
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Netherlands
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Noord-Brabant
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Netherlands
State/province [92] 0 0
Zuid-Holland
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Netherlands
State/province [93] 0 0
Amsterdam
Country [94] 0 0
Poland
State/province [94] 0 0
Gdansk
Country [95] 0 0
Poland
State/province [95] 0 0
Warszawa
Country [96] 0 0
Romania
State/province [96] 0 0
Bucure?ti
Country [97] 0 0
Romania
State/province [97] 0 0
Constan?a
Country [98] 0 0
Romania
State/province [98] 0 0
Timi?
Country [99] 0 0
Romania
State/province [99] 0 0
Bucuresti
Country [100] 0 0
Romania
State/province [100] 0 0
Cluj-Napoca
Country [101] 0 0
Romania
State/province [101] 0 0
Suceava
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Baškortostan, Respublika
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Kalužskaja Oblast
Country [104] 0 0
Russian Federation
State/province [104] 0 0
Murmanskaya Oblast'
Country [105] 0 0
Russian Federation
State/province [105] 0 0
Samarskaya Oblast'
Country [106] 0 0
Russian Federation
State/province [106] 0 0
Sankt-Peterburg
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Arkhangelsk
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Kazan
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Moscow
Country [110] 0 0
Singapore
State/province [110] 0 0
Singapore
Country [111] 0 0
Spain
State/province [111] 0 0
Baleares
Country [112] 0 0
Spain
State/province [112] 0 0
Barcelona [Barcelona]
Country [113] 0 0
Spain
State/province [113] 0 0
Galicia [Galicia]
Country [114] 0 0
Spain
State/province [114] 0 0
Las Palmas
Country [115] 0 0
Spain
State/province [115] 0 0
Madrid
Country [116] 0 0
Spain
State/province [116] 0 0
Navarra
Country [117] 0 0
Spain
State/province [117] 0 0
Alicante
Country [118] 0 0
Spain
State/province [118] 0 0
Barcelona
Country [119] 0 0
Spain
State/province [119] 0 0
Jaén
Country [120] 0 0
Spain
State/province [120] 0 0
Malaga
Country [121] 0 0
Spain
State/province [121] 0 0
Pamplona
Country [122] 0 0
Spain
State/province [122] 0 0
Sevilla
Country [123] 0 0
Spain
State/province [123] 0 0
Valencia
Country [124] 0 0
Taiwan
State/province [124] 0 0
Changhua
Country [125] 0 0
Taiwan
State/province [125] 0 0
Chiayi
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taoyuan County
Country [127] 0 0
Taiwan
State/province [127] 0 0
Kaohsiung
Country [128] 0 0
Taiwan
State/province [128] 0 0
Neihu Taipei
Country [129] 0 0
Taiwan
State/province [129] 0 0
New Taipei
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taichung
Country [131] 0 0
Taiwan
State/province [131] 0 0
Tainan City
Country [132] 0 0
Taiwan
State/province [132] 0 0
Tainan
Country [133] 0 0
Taiwan
State/province [133] 0 0
Taipei City
Country [134] 0 0
Taiwan
State/province [134] 0 0
Taipei
Country [135] 0 0
Turkey
State/province [135] 0 0
Izmir
Country [136] 0 0
Turkey
State/province [136] 0 0
Adana
Country [137] 0 0
Turkey
State/province [137] 0 0
Ankara
Country [138] 0 0
Turkey
State/province [138] 0 0
Antalya
Country [139] 0 0
Turkey
State/province [139] 0 0
Diyarbakir
Country [140] 0 0
Turkey
State/province [140] 0 0
Edirne
Country [141] 0 0
Turkey
State/province [141] 0 0
Istanbul
Country [142] 0 0
Turkey
State/province [142] 0 0
Malatya
Country [143] 0 0
Turkey
State/province [143] 0 0
Sariyer
Country [144] 0 0
Ukraine
State/province [144] 0 0
Dnipropetrovska Oblast
Country [145] 0 0
Ukraine
State/province [145] 0 0
Kharkivska Oblast
Country [146] 0 0
Ukraine
State/province [146] 0 0
Odeska Oblast
Country [147] 0 0
Ukraine
State/province [147] 0 0
Sumska Oblast
Country [148] 0 0
Ukraine
State/province [148] 0 0
Vinnytska Oblast
Country [149] 0 0
Ukraine
State/province [149] 0 0
Volynska Oblast
Country [150] 0 0
Ukraine
State/province [150] 0 0
Zaporizka Oblast
Country [151] 0 0
Ukraine
State/province [151] 0 0
Chernivtsi
Country [152] 0 0
Ukraine
State/province [152] 0 0
Kryvyi Rig
Country [153] 0 0
Ukraine
State/province [153] 0 0
Kyiv
Country [154] 0 0
Ukraine
State/province [154] 0 0
Odesa
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Nottinghamshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Loxo Oncology, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04194944