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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
Date last updated
24/07/2025
Titles & IDs
Public title
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
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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
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Secondary ID [1]
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J2G-MC-JZJX
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Secondary ID [2]
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18126
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Universal Trial Number (UTN)
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Trial acronym
LIBRETTO-432
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-Free Survival (EFS)
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Assessment method [1]
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EFS by Investigator Assessment in the Primary Analysis Population
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Timepoint [1]
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Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
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Secondary outcome [1]
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EFS
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Assessment method [1]
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EFS by investigator assessment in the overall population
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Timepoint [1]
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Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS
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Timepoint [2]
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Randomization to death from any cause (estimated as up to 9 years)]
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Secondary outcome [3]
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EFS
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Assessment method [3]
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EFS by blinded independent central review (BICR)
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Timepoint [3]
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Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]
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Secondary outcome [4]
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Time to Distant Disease Recurrence in the Central Nervous System (CNS)
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Assessment method [4]
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Time to distant disease recurrence in the CNS by investigator assessment and BICR
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Timepoint [4]
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Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
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Secondary outcome [5]
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Progression Free Survival on the Next Line of Treatment (PFS2)
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Assessment method [5]
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PFS2 by investigator assessment
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Timepoint [5]
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Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)
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Secondary outcome [6]
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Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test
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Assessment method [6]
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PPV of RET Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test
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Timepoint [6]
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Baseline
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Secondary outcome [7]
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Mean Change from Baseline over Time in NSCLC Symptoms
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Assessment method [7]
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NSCLC symptoms will be measured using the 7-item NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). The NSCLC-SAQ measures the severity/frequency of the following core symptoms: Cough, pain, dyspnea, fatigue, and appetite. Raw scores range from 0 to 4 and the total score ranges from 0-20. Higher scores represent worse symptoms.
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Timepoint [7]
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Baseline to treatment discontinuation (estimated as up to 3 years)
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Secondary outcome [8]
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Mean Change from Baseline over Time in Physical Function
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Assessment method [8]
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Physical function will be measured by the 5 physical function items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (also known as the EORTC IL 19 questionnaire). Raw scores range from 0-20. Higher scores indicate worst function.
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Timepoint [8]
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Baseline to treatment discontinuation (estimated as up to 3 years)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2028
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Actual
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Sample size
Target
152
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Sunshine Coast University Hospital - Birtinya
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Rockhampton Hospital - Rockhampton
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The Townsville Hospital - Townsville
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Ballarat Health Services - Ballarat Central
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Bendigo Health Care Group - Bendigo
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Goulburn Valley Health - Shepparton
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South West Healthcare - Warrnambool
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Recruitment hospital [8]
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Border Medical Oncology - Wodonga
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Recruitment postcode(s) [1]
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4575 - Birtinya
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Recruitment postcode(s) [2]
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4700 - Rockhampton
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4814 - Townsville
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3350 - Ballarat Central
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3550 - Bendigo
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3630 - Shepparton
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3280 - Warrnambool
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Recruitment postcode(s) [8]
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3690 - Wodonga
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Recruitment outside Australia
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Attikí
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India
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National Capital Territory of Delhi
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Israel
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?eifa
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Spain
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Principality of Asturias
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Spain
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Santa Cruz De Tenerife
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Spain
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Tarragona [Tarragona]
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Spain
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Albacete
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Seville
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Spain
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Valencia
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Sweden
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Västra Götalands Län [se-14]
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Kaohsiung City
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Taiwan
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Taoyuan District
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Turkey (Türkiye)
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Izmir
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Turkey (Türkiye)
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Adana
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Turkey (Türkiye)
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Ankara
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Turkey (Türkiye)
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Antalya
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Turkey (Türkiye)
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Bursa
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Turkey (Türkiye)
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Diyarbakir
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Turkey (Türkiye)
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Edirne
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Turkey (Türkiye)
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Istanbul
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Turkey (Türkiye)
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Malatya
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Ukraine
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Dnipropetrovsk Oblast
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Ukraine
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Kharkivs’ka Oblast’
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Ukraine
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Odesa Oblast
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Ukraine
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Sumska Oblast
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Ukraine
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Vinnytsia Oblast
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Ukraine
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Zaporizhzhia Oblast
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Ukraine
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Kyiv
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United Kingdom
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England
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United Kingdom
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Kensington and Chelsea
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United Kingdom
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London, City of
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United Kingdom
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Nottingham
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Loxo Oncology, Inc.
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Ethics approval
Ethics application status
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Summary
Brief summary
The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.
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Trial website
https://clinicaltrials.gov/study/NCT04819100
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Trial related presentations / publications
Tsuboi M, Goldman JW, Wu YL, Johnson ML, Paz-Ares L, Yang JC, Besse B, Su W, Chao BH, Drilon A. LIBRETTO-432, a phase III study of adjuvant selpercatinib or placebo in stage IB-IIIA RET fusion-positive non-small-cell lung cancer. Future Oncol. 2022 Sep;18(28):3133-3141. doi: 10.2217/fon-2022-0656. Epub 2022 Aug 11.
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Public notes
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Contacts
Principal investigator
Name
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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)
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Eli Lilly and Company
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Contact person for public queries
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There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
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Phone
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1-317-615-4559
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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
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