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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04819100




Registration number
NCT04819100
Ethics application status
Date submitted
25/03/2021
Date registered
26/03/2021

Titles & IDs
Public title
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
Scientific title
LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC
Secondary ID [1] 0 0
J2G-MC-JZJX
Secondary ID [2] 0 0
18126
Universal Trial Number (UTN)
Trial acronym
LIBRETTO-432
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Selpercatinib
Treatment: Drugs - Placebo

Experimental: Selpercatinib - Selpercatinib administered orally.

Placebo comparator: Placebo - Placebo administered orally.


Treatment: Drugs: Selpercatinib
Administered orally.

Treatment: Drugs: Placebo
Administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-Free Survival (EFS)
Timepoint [1] 0 0
Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Secondary outcome [1] 0 0
EFS
Timepoint [1] 0 0
Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Randomization to death from any cause (estimated as up to 9 years)]
Secondary outcome [3] 0 0
EFS
Timepoint [3] 0 0
Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]
Secondary outcome [4] 0 0
Time to Distant Disease Recurrence in the Central Nervous System (CNS)
Timepoint [4] 0 0
Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Secondary outcome [5] 0 0
Progression Free Survival on the Next Line of Treatment (PFS2)
Timepoint [5] 0 0
Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)
Secondary outcome [6] 0 0
Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Mean Change from Baseline over Time in NSCLC Symptoms
Timepoint [7] 0 0
Baseline to treatment discontinuation (estimated as up to 3 years)
Secondary outcome [8] 0 0
Mean Change from Baseline over Time in Physical Function
Timepoint [8] 0 0
Baseline to treatment discontinuation (estimated as up to 3 years)

Eligibility
Key inclusion criteria
* Must have histologically confirmed Stage IB, II, or IIIA NSCLC.
* Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR), next generation sequencing (NGS), or another molecular test per sponsor's approval.
* Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC.

-- Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion.
* Maximum time allowed between definitive therapy completion and randomization must be:

* 10 weeks if no chemotherapy was administered
* 26 weeks if adjuvant chemotherapy was administered
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Adequate hematologic, hepatic, and renal function.
* Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of the study and for at least 2 weeks after last dose of study drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Additional oncogenic drivers in NSCLC, if known.
* Evidence of small cell lung cancer.
* Clinical or radiologic evidence of disease recurrence or progression following definitive therapy.
* Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids.
* Clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 470 milliseconds.
* Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection.
* Have known active hepatitis B or C.
* Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.
* Major surgery within 4 weeks prior to planned start of selpercatinib.
* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
* Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active.
* Pregnancy or lactation.
* Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2032
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 0 0
Rockhampton Hospital - Rockhampton
Recruitment hospital [4] 0 0
The Townsville Hospital - Townsville
Recruitment hospital [5] 0 0
Ballarat Health Services - Ballarat Central
Recruitment hospital [6] 0 0
Bendigo Health Care Group - Bendigo
Recruitment hospital [7] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [8] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
4700 - Rockhampton
Recruitment postcode(s) [4] 0 0
4814 - Townsville
Recruitment postcode(s) [5] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [6] 0 0
3550 - Bendigo
Recruitment postcode(s) [7] 0 0
3630 - Shepparton
Recruitment postcode(s) [8] 0 0
3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Austria
State/province [8] 0 0
Vorarlberg
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles-Capitale, Région De
Country [12] 0 0
Belgium
State/province [12] 0 0
Namur
Country [13] 0 0
Belgium
State/province [13] 0 0
Wallonne, Région
Country [14] 0 0
Belgium
State/province [14] 0 0
West-Vlaanderen
Country [15] 0 0
Brazil
State/province [15] 0 0
Bahia
Country [16] 0 0
Brazil
State/province [16] 0 0
Distrito Federal
Country [17] 0 0
Brazil
State/province [17] 0 0
Minas Gerais
Country [18] 0 0
Brazil
State/province [18] 0 0
Pernambuco
Country [19] 0 0
Brazil
State/province [19] 0 0
Rio Grande Do Sul
Country [20] 0 0
Brazil
State/province [20] 0 0
São Paulo
Country [21] 0 0
Brazil
State/province [21] 0 0
Rio de Janeiro
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
Fujian
Country [25] 0 0
China
State/province [25] 0 0
Guangdong
Country [26] 0 0
China
State/province [26] 0 0
Heilongjiang
Country [27] 0 0
China
State/province [27] 0 0
Hubei
Country [28] 0 0
China
State/province [28] 0 0
Hunan
Country [29] 0 0
China
State/province [29] 0 0
Jilin
Country [30] 0 0
China
State/province [30] 0 0
Shaanxi
Country [31] 0 0
China
State/province [31] 0 0
Shandong
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Sichuan
Country [34] 0 0
China
State/province [34] 0 0
Zhejiang
Country [35] 0 0
Czechia
State/province [35] 0 0
Brno-mesto
Country [36] 0 0
Czechia
State/province [36] 0 0
Ostrava Mesto
Country [37] 0 0
Czechia
State/province [37] 0 0
Praha 8
Country [38] 0 0
Denmark
State/province [38] 0 0
Syddanmark
Country [39] 0 0
France
State/province [39] 0 0
Bouches-du-Rhône
Country [40] 0 0
France
State/province [40] 0 0
Haute-Normandie
Country [41] 0 0
France
State/province [41] 0 0
Hauts-de-Seine
Country [42] 0 0
France
State/province [42] 0 0
Rhône-Alpes
Country [43] 0 0
France
State/province [43] 0 0
Rhône
Country [44] 0 0
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
Hessen
Country [48] 0 0
Germany
State/province [48] 0 0
Niedersachsen
Country [49] 0 0
Germany
State/province [49] 0 0
Nordrhein-Westfalen
Country [50] 0 0
Germany
State/province [50] 0 0
Schleswig-Holstein
Country [51] 0 0
Germany
State/province [51] 0 0
Berlin
Country [52] 0 0
Germany
State/province [52] 0 0
Hamburg
Country [53] 0 0
Greece
State/province [53] 0 0
Acha?a
Country [54] 0 0
Greece
State/province [54] 0 0
Attikí
Country [55] 0 0
Greece
State/province [55] 0 0
Irakleío
Country [56] 0 0
Greece
State/province [56] 0 0
Thessaloníki
Country [57] 0 0
Hong Kong
State/province [57] 0 0
Hong Kong
Country [58] 0 0
Hong Kong
State/province [58] 0 0
Lai Chi Kok
Country [59] 0 0
Hong Kong
State/province [59] 0 0
Yau Ma Tei
Country [60] 0 0
India
State/province [60] 0 0
Delhi
Country [61] 0 0
India
State/province [61] 0 0
Kerala
Country [62] 0 0
India
State/province [62] 0 0
Maharashtra
Country [63] 0 0
Israel
State/province [63] 0 0
HaMerkaz
Country [64] 0 0
Israel
State/province [64] 0 0
Yerushalayim
Country [65] 0 0
Israel
State/province [65] 0 0
?eifa
Country [66] 0 0
Italy
State/province [66] 0 0
Milano
Country [67] 0 0
Italy
State/province [67] 0 0
Napoli
Country [68] 0 0
Italy
State/province [68] 0 0
Puglia
Country [69] 0 0
Italy
State/province [69] 0 0
Torino
Country [70] 0 0
Italy
State/province [70] 0 0
Padova
Country [71] 0 0
Japan
State/province [71] 0 0
Aichi
Country [72] 0 0
Japan
State/province [72] 0 0
Chiba
Country [73] 0 0
Japan
State/province [73] 0 0
Hyogo
Country [74] 0 0
Japan
State/province [74] 0 0
Kanagawa
Country [75] 0 0
Japan
State/province [75] 0 0
Shizuoka
Country [76] 0 0
Japan
State/province [76] 0 0
Tokyo
Country [77] 0 0
Japan
State/province [77] 0 0
Tottori
Country [78] 0 0
Japan
State/province [78] 0 0
Hiroshima
Country [79] 0 0
Japan
State/province [79] 0 0
Niigata
Country [80] 0 0
Japan
State/province [80] 0 0
Osaka
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Jeonranamdo
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Kyonggi-do
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Pusan-Kwangyokshi
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Seoul-teukbyeolsi [Seoul]
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Taegu-Kwangyokshi
Country [86] 0 0
Mexico
State/province [86] 0 0
Jalisco
Country [87] 0 0
Mexico
State/province [87] 0 0
México
Country [88] 0 0
Mexico
State/province [88] 0 0
Nuevo León
Country [89] 0 0
Netherlands
State/province [89] 0 0
Gelderland
Country [90] 0 0
Norway
State/province [90] 0 0
Oslo
Country [91] 0 0
Poland
State/province [91] 0 0
Mazowieckie
Country [92] 0 0
Poland
State/province [92] 0 0
Pomorskie
Country [93] 0 0
Poland
State/province [93] 0 0
Wielkopolskie
Country [94] 0 0
Puerto Rico
State/province [94] 0 0
Rio Piedras
Country [95] 0 0
Romania
State/province [95] 0 0
Cluj
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Arkhangel'skaya Oblast'
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Moskva
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Sankt-Peterburg
Country [99] 0 0
Singapore
State/province [99] 0 0
Central Singapore
Country [100] 0 0
Spain
State/province [100] 0 0
A Coruña [La Coruña]
Country [101] 0 0
Spain
State/province [101] 0 0
Andalucía
Country [102] 0 0
Spain
State/province [102] 0 0
Asturias
Country [103] 0 0
Spain
State/province [103] 0 0
Barcelona [Barcelona]
Country [104] 0 0
Spain
State/province [104] 0 0
Castilla Y León
Country [105] 0 0
Spain
State/province [105] 0 0
Catalunya [Cataluña]
Country [106] 0 0
Spain
State/province [106] 0 0
Illes Balears [Islas Baleares]
Country [107] 0 0
Spain
State/province [107] 0 0
Lugo [Lugo]
Country [108] 0 0
Spain
State/province [108] 0 0
Madrid, Comunidad De
Country [109] 0 0
Spain
State/province [109] 0 0
Murcia, Región De
Country [110] 0 0
Spain
State/province [110] 0 0
Ourense [Orense]
Country [111] 0 0
Spain
State/province [111] 0 0
Pontevedra [Pontevedra]
Country [112] 0 0
Spain
State/province [112] 0 0
Santa Cruz De Tenerife
Country [113] 0 0
Spain
State/province [113] 0 0
Tarragona [Tarragona]
Country [114] 0 0
Spain
State/province [114] 0 0
Albacete
Country [115] 0 0
Spain
State/province [115] 0 0
Madrid
Country [116] 0 0
Spain
State/province [116] 0 0
Málaga
Country [117] 0 0
Spain
State/province [117] 0 0
Sevilla
Country [118] 0 0
Spain
State/province [118] 0 0
València
Country [119] 0 0
Sweden
State/province [119] 0 0
Västra Götalands Län [se-14]
Country [120] 0 0
Taiwan
State/province [120] 0 0
Changhua
Country [121] 0 0
Taiwan
State/province [121] 0 0
Kaohsiung
Country [122] 0 0
Taiwan
State/province [122] 0 0
Taichung
Country [123] 0 0
Taiwan
State/province [123] 0 0
Tainan
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taipei
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taoyuan
Country [126] 0 0
Turkey
State/province [126] 0 0
Diyarbakir
Country [127] 0 0
Turkey
State/province [127] 0 0
Izmir
Country [128] 0 0
Turkey
State/province [128] 0 0
Adana
Country [129] 0 0
Turkey
State/province [129] 0 0
Ankara
Country [130] 0 0
Turkey
State/province [130] 0 0
Antalya
Country [131] 0 0
Turkey
State/province [131] 0 0
Bursa
Country [132] 0 0
Turkey
State/province [132] 0 0
Edirne
Country [133] 0 0
Turkey
State/province [133] 0 0
Istanbul
Country [134] 0 0
Turkey
State/province [134] 0 0
Malatya
Country [135] 0 0
Ukraine
State/province [135] 0 0
Sumska Oblast
Country [136] 0 0
United Kingdom
State/province [136] 0 0
England
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Kensington And Chelsea
Country [138] 0 0
United Kingdom
State/province [138] 0 0
London, City Of
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Nottingham
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Wolverhampton

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
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
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: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04819100