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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
21/02/2021

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 - 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 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)
Primary outcome [2] 0 0
PFS by BICR (with or without Pembrolizumab) - PFS by BICR (with or without Pembrolizumab)
Timepoint [2] 0 0
Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)
Secondary outcome [1] 0 0
Disease Control Rate (DCR) by BICR (with Pembrolizumab) - DCR 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
DCR by BICR (with or without Pembrolizumab) - DCR by BICR (with or without Pembrolizumab)
Timepoint [2] 0 0
Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)
Secondary outcome [3] 0 0
PFS2 (with Pembrolizumab) - PFS2 (with Pembrolizumab)
Timepoint [3] 0 0
Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months)
Secondary outcome [4] 0 0
PFS2 (with or without Pembrolizumab) - PFS2 (with or without Pembrolizumab)
Timepoint [4] 0 0
Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 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) - ORR: Percentage of Participants with CR or PR by BICR (with Pembrolizumab)
Timepoint [5] 0 0
Baseline through Disease Progression or Death (Estimated at up to 24 Months)
Secondary outcome [6] 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 [6] 0 0
Baseline through Disease Progression or Death (Estimated at up to 24 Months)
Secondary outcome [7] 0 0
Duration of Response (DoR) by BICR (with Pembrolizumab) - 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 (Estimated at up to 24 Months)
Secondary outcome [8] 0 0
DOR by BICR (with or without Pembrolizumab) - 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 (Estimated at up to 24 Months)
Secondary outcome [9] 0 0
Overall Survival (OS) (with Pembrolizumab) - OS (with Pembrolizumab)
Timepoint [9] 0 0
Baseline to Date of Death from Any Cause (Estimated at up to 48 Months)
Secondary outcome [10] 0 0
OS (with or without Pembrolizumab) - OS (with or without Pembrolizumab)
Timepoint [10] 0 0
Baseline to Date of Death from Any Cause (Estimated at up to 48 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) - Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab)
Timepoint [11] 0 0
Baseline through Central Nervous System (CNS) Progression or Death (Estimated at up to 24 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) - 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 (Estimated at up to 24 Months)
Secondary outcome [13] 0 0
Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab) - 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 (Estimated at up to 24 Months)
Secondary outcome [14] 0 0
Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab) - 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 (Estimated at up to 24 Months)
Secondary outcome [15] 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 [15] 0 0
Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 Months)
Secondary outcome [16] 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 [16] 0 0
Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 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) - 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
Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab) - Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab)
Timepoint [18] 0 0
Baseline through CNS Progression or Death (Estimated at up to 24 Months)
Secondary outcome [19] 0 0
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)
Timepoint [19] 0 0
Baseline through CNS Progression or Death (Estimated at up to 24 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) - Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with Pembrolizumab)
Timepoint [20] 0 0
Baseline through CNS Progression or Death (Estimated at up to 24 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) - 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 (Estimated at up to 24 Months)
Secondary outcome [22] 0 0
Intracranial DOR per RANO-BM by BICR (with Pembrolizumab) - 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 (Estimated at up to 24 Months)
Secondary outcome [23] 0 0
Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab) - 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 (Estimated at up to 24 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
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. 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/08/2025
Actual
Sample size
Target
250
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
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Rio 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
Brussel
Country [6] 0 0
Belgium
State/province [6] 0 0
Antwerpen
Country [7] 0 0
Belgium
State/province [7] 0 0
Gent
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Mechelen
Country [10] 0 0
Belgium
State/province [10] 0 0
Namur
Country [11] 0 0
Belgium
State/province [11] 0 0
Roeselare
Country [12] 0 0
Belgium
State/province [12] 0 0
Sint Niklaas
Country [13] 0 0
Brazil
State/province [13] 0 0
Bahia
Country [14] 0 0
Brazil
State/province [14] 0 0
Minas Gerais
Country [15] 0 0
Brazil
State/province [15] 0 0
Parana
Country [16] 0 0
Brazil
State/province [16] 0 0
RJ
Country [17] 0 0
Brazil
State/province [17] 0 0
RS
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Brazil
State/province [19] 0 0
SP
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
Brazil
State/province [22] 0 0
Sao Paolo
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
China
State/province [25] 0 0
Guangdong
Country [26] 0 0
China
State/province [26] 0 0
Guangzhou
Country [27] 0 0
China
State/province [27] 0 0
Heilongjiang
Country [28] 0 0
China
State/province [28] 0 0
Hubei
Country [29] 0 0
China
State/province [29] 0 0
Hunan
Country [30] 0 0
China
State/province [30] 0 0
Jiangsu
Country [31] 0 0
China
State/province [31] 0 0
Jilin
Country [32] 0 0
China
State/province [32] 0 0
Shanxi
Country [33] 0 0
China
State/province [33] 0 0
Sichuan
Country [34] 0 0
China
State/province [34] 0 0
Xinjiang
Country [35] 0 0
China
State/province [35] 0 0
Zhejiang
Country [36] 0 0
China
State/province [36] 0 0
Beijing
Country [37] 0 0
China
State/province [37] 0 0
Changsha
Country [38] 0 0
China
State/province [38] 0 0
Hangzhou
Country [39] 0 0
China
State/province [39] 0 0
Shanghai
Country [40] 0 0
Czechia
State/province [40] 0 0
Olomouc
Country [41] 0 0
Czechia
State/province [41] 0 0
Ostrava - Vitkovice
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha 8
Country [43] 0 0
France
State/province [43] 0 0
Cedex 1
Country [44] 0 0
France
State/province [44] 0 0
Rhône-Alpes
Country [45] 0 0
France
State/province [45] 0 0
Cs10217 Grenoble Cedex 9
Country [46] 0 0
France
State/province [46] 0 0
Marseille Cedex 20
Country [47] 0 0
France
State/province [47] 0 0
Montpellier Cedex 5
Country [48] 0 0
France
State/province [48] 0 0
Paris
Country [49] 0 0
Germany
State/province [49] 0 0
Baden-Württemberg
Country [50] 0 0
Germany
State/province [50] 0 0
Bayern
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Germany
State/province [51] 0 0
Niedersachsen
Country [52] 0 0
Germany
State/province [52] 0 0
Nordrhein-Westfalen
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Germany
State/province [53] 0 0
Schleswig-Holstein
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Germany
State/province [54] 0 0
Berlin
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Greece
State/province [55] 0 0
Crete
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Greece
State/province [56] 0 0
Thessaloniki
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Greece
State/province [57] 0 0
Athens
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Greece
State/province [58] 0 0
Pylaia/Thessaloniki
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Hong Kong
State/province [59] 0 0
Kowloon
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Hong Kong
State/province [60] 0 0
Shatin
Country [61] 0 0
Israel
State/province [61] 0 0
Beer-Sheva
Country [62] 0 0
Israel
State/province [62] 0 0
Haifa
Country [63] 0 0
Israel
State/province [63] 0 0
Jerusalem
Country [64] 0 0
Israel
State/province [64] 0 0
Ramat Gan
Country [65] 0 0
Italy
State/province [65] 0 0
Lazio
Country [66] 0 0
Italy
State/province [66] 0 0
Milano
Country [67] 0 0
Italy
State/province [67] 0 0
Naples
Country [68] 0 0
Italy
State/province [68] 0 0
Pordenone
Country [69] 0 0
Italy
State/province [69] 0 0
Torino
Country [70] 0 0
Italy
State/province [70] 0 0
Avellino
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Italy
State/province [71] 0 0
Bologna
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Italy
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Pisa
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Italy
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Ravenna
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Japan
State/province [74] 0 0
Chiba
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Japan
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Hokkaido
Country [76] 0 0
Japan
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Hyogo
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Japan
State/province [77] 0 0
Ishikawa
Country [78] 0 0
Japan
State/province [78] 0 0
Kanagawa
Country [79] 0 0
Japan
State/province [79] 0 0
Osaka
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Japan
State/province [80] 0 0
Shizuoka
Country [81] 0 0
Japan
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Tokyo
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Japan
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Tottori
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Japan
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Okayama
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangnam-do
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Korea, Republic of
State/province [86] 0 0
Korea
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Korea, Republic of
State/province [87] 0 0
Seoul, Korea
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Daejon
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Korea, Republic of
State/province [89] 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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's-Hertogenbosch
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Netherlands
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Amsterdam
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Netherlands
State/province [95] 0 0
Harderwijk
Country [96] 0 0
Netherlands
State/province [96] 0 0
Rotterdam
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Poland
State/province [97] 0 0
Gdansk
Country [98] 0 0
Poland
State/province [98] 0 0
Warszawa
Country [99] 0 0
Romania
State/province [99] 0 0
Dolj
Country [100] 0 0
Romania
State/province [100] 0 0
Sector 2
Country [101] 0 0
Romania
State/province [101] 0 0
Bucuresti
Country [102] 0 0
Romania
State/province [102] 0 0
Cluj-Napoca
Country [103] 0 0
Romania
State/province [103] 0 0
Constanta
Country [104] 0 0
Romania
State/province [104] 0 0
Suceava
Country [105] 0 0
Romania
State/province [105] 0 0
Timisoara
Country [106] 0 0
Russian Federation
State/province [106] 0 0
Leningradsky Reg.
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Arkhangelsk
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Russian Federation
State/province [108] 0 0
Kaluga
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Kazan
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Russian Federation
State/province [110] 0 0
Krasnodar
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Moscow
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Russian Federation
State/province [112] 0 0
Murmansk
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Samara
Country [114] 0 0
Russian Federation
State/province [114] 0 0
St. Petersburg
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Ufa
Country [116] 0 0
Singapore
State/province [116] 0 0
Singapore
Country [117] 0 0
Spain
State/province [117] 0 0
Baleares
Country [118] 0 0
Spain
State/province [118] 0 0
La Coruna
Country [119] 0 0
Spain
State/province [119] 0 0
Las Palmas
Country [120] 0 0
Spain
State/province [120] 0 0
Madrid
Country [121] 0 0
Spain
State/province [121] 0 0
Navarra
Country [122] 0 0
Spain
State/province [122] 0 0
Alicante
Country [123] 0 0
Spain
State/province [123] 0 0
Badalona
Country [124] 0 0
Spain
State/province [124] 0 0
Barcelona
Country [125] 0 0
Spain
State/province [125] 0 0
Jaen
Country [126] 0 0
Spain
State/province [126] 0 0
Malaga
Country [127] 0 0
Spain
State/province [127] 0 0
Pamplona
Country [128] 0 0
Spain
State/province [128] 0 0
Salamanca
Country [129] 0 0
Spain
State/province [129] 0 0
Sevilla
Country [130] 0 0
Spain
State/province [130] 0 0
Valencia
Country [131] 0 0
Taiwan
State/province [131] 0 0
Changhua
Country [132] 0 0
Taiwan
State/province [132] 0 0
Chiayi
Country [133] 0 0
Taiwan
State/province [133] 0 0
Taichung
Country [134] 0 0
Taiwan
State/province [134] 0 0
Taoyuan County
Country [135] 0 0
Taiwan
State/province [135] 0 0
Kaohsiung City
Country [136] 0 0
Taiwan
State/province [136] 0 0
Kaohsiung
Country [137] 0 0
Taiwan
State/province [137] 0 0
Neihu Taipei
Country [138] 0 0
Taiwan
State/province [138] 0 0
New Taipei
Country [139] 0 0
Taiwan
State/province [139] 0 0
Tainan City
Country [140] 0 0
Taiwan
State/province [140] 0 0
Tainan
Country [141] 0 0
Taiwan
State/province [141] 0 0
Taipei City
Country [142] 0 0
Taiwan
State/province [142] 0 0
Taipei
Country [143] 0 0
Turkey
State/province [143] 0 0
Izmir
Country [144] 0 0
Turkey
State/province [144] 0 0
Adana
Country [145] 0 0
Turkey
State/province [145] 0 0
Ankara
Country [146] 0 0
Turkey
State/province [146] 0 0
Diyarbakir
Country [147] 0 0
Turkey
State/province [147] 0 0
Edirne
Country [148] 0 0
Turkey
State/province [148] 0 0
Istanbul
Country [149] 0 0
Turkey
State/province [149] 0 0
Kepez
Country [150] 0 0
Turkey
State/province [150] 0 0
Malatya
Country [151] 0 0
Turkey
State/province [151] 0 0
Sariyer
Country [152] 0 0
Ukraine
State/province [152] 0 0
Chernivtsi
Country [153] 0 0
Ukraine
State/province [153] 0 0
Dnipro
Country [154] 0 0
Ukraine
State/province [154] 0 0
Kharkiv
Country [155] 0 0
Ukraine
State/province [155] 0 0
Kropyvnytskyi
Country [156] 0 0
Ukraine
State/province [156] 0 0
Kryvyi Rig
Country [157] 0 0
Ukraine
State/province [157] 0 0
Kyiv
Country [158] 0 0
Ukraine
State/province [158] 0 0
Lutsk
Country [159] 0 0
Ukraine
State/province [159] 0 0
Odesa
Country [160] 0 0
Ukraine
State/province [160] 0 0
Sumy
Country [161] 0 0
Ukraine
State/province [161] 0 0
Vinnytsia
Country [162] 0 0
Ukraine
State/province [162] 0 0
Zaporizhya
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Nottinghamshire
Country [164] 0 0
United Kingdom
State/province [164] 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