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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04194944
Ethics application status
Date submitted
9/12/2019
Date registered
11/12/2019
Date last updated
17/06/2020

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 LOXO-292 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Selpercatinib
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Pembrolizumab

Experimental: Selpercatinib - Selpercatinib administered orally.

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

Active Comparator: Pemetrexed with Pembrolizumab - Pemetrexed administered IV plus the investigator's discretion of carboplatin IV or cisplatin IV with pembrolizumab IV.


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 or without Pembrolizumab) - PFS by BICR (with or without Pembrolizumab)
Timepoint [1] 0 0
Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)
Secondary outcome [1] 0 0
PFS by BICR (with Pembrolizumab) - PFS by BICR (with Pembrolizumab)
Timepoint [1] 0 0
Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)
Secondary outcome [2] 0 0
PFS2 (with or without Pembrolizumab) - PFS2 (with or without Pembrolizumab)
Timepoint [2] 0 0
Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months)
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Baseline through Disease Progression or Death (Estimated at up to 24 Months)
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Baseline through Disease Progression or Death (Estimated at up to 24 Months)
Secondary outcome [5] 0 0
Duration of Response (DoR) by BICR (with Pembrolizumab) - DOR by BICR (with Pembrolizumab)
Timepoint [5] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 24 Months)
Secondary outcome [6] 0 0
DOR by BICR (with or without Pembrolizumab) - DOR by BICR (with or without Pembrolizumab)
Timepoint [6] 0 0
Baseline through Disease Progression or Death (Estimated at up to 24 Months)
Secondary outcome [7] 0 0
Overall Survival (OS) (with Pembrolizumab) - OS (with Pembrolizumab)
Timepoint [7] 0 0
Baseline to Date of Death from Any Cause (Estimated at up to 48 Months)
Secondary outcome [8] 0 0
OS (with or without Pembrolizumab) - OS (with or without Pembrolizumab)
Timepoint [8] 0 0
Baseline to Date of Death from Any Cause (Estimated at up to 48 Months)
Secondary outcome [9] 0 0
Intracranial ORR: Percentage of Participants with Intracranial CR or PR by BICR (with or without Pembrolizumab) - Intracranial ORR: Percentage of Participants with Intracranial CR or PR by BICR (with or without Pembrolizumab)
Timepoint [9] 0 0
Baseline through Disease Progression or Death (Estimated at up to 24 Months)
Secondary outcome [10] 0 0
Intracranial DOR by BICR (with or without Pembrolizumab) - Intracranial DOR by BICR (with or without Pembrolizumab)
Timepoint [10] 0 0
Baseline through Disease Progression or Death (Estimated at up to 24 Months)
Secondary outcome [11] 0 0
Time to Deterioration of Pulmonary Symptoms (with Pembrolizumab) - Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) (with Pembrolizumab)
Timepoint [11] 0 0
Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 Months)
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 Months)
Secondary outcome [13] 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) - 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 [13] 0 0
Baseline

Eligibility
Key inclusion criteria
- Histologically 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.

- Tumor tissue in sufficient quantity to allow for retrospective central analysis of RET
fusion status.

- 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
Gender
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. Chemotherapy in the
adjuvant/neoadjuvant setting is permitted if it was completed at least 12 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
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, leptomeningeal carcinomatosis, 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
malignancy diagnosed =2 years previously and not currently active.

- Symptomatic ascites 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [6] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [7] 0 0
Slade Pharmacy - Frankston
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [9] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2145 - Wentworthville
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3149 - Frankston
Recruitment postcode(s) [8] 0 0
3000 - Melbourne
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment outside Australia
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California
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Tennessee
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Wisconsin
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Argentina
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Gent
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Leuven
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Mechelen
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Namur
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Roeselare
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Sint Niklaas
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Parana
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RJ
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Cs10217 Grenoble Cedex 9
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Samara
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Sevilla
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Valencia
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Taoyuan County
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Changhua
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Kaohsiung
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New Taipei
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Diyarbakir
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Edirne
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Istanbul
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Izmir
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Turkey
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Kepez
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Turkey
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Malatya
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Turkey
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Sariyer
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Ukraine
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Chernivtsi
Country [154] 0 0
Ukraine
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Dnipro
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Ukraine
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Kharkiv
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Ukraine
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Kropyvnytskyi
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Ukraine
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Kryvyi Rig
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Sumy
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhya
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United Kingdom
State/province [165] 0 0
Nottinghamshire
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United Kingdom
State/province [166] 0 0
Surrey

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

Ethics approval
Ethics application status

Summary
Brief summary
The reason for this study is to see if the study drug selpercatinib compared to a standard
treatment is effective and safe in participants with rearranged during transfection (RET)
fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other
parts of the body. Participants who are assigned to the standard treatment and discontinue
due to progressive disease have the option to potentially crossover to selpercatinib.
Trial website
https://clinicaltrials.gov/show/NCT04194944
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 will 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
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04194944