🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Turkey / NCT04194944
Active, not recruiting Phase 3

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

NCT04194944 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 3
Started
2020-02-17
Last updated
2025-10-21

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Selpercatinib →Carboplatin →Cisplatin →Pemetrexed →Pembrolizumab →

Selpercatinib: Administered orally

Carboplatin: Administered IV

Cisplatin: Administered IV

Pemetrexed: Administered IV

Pembrolizumab: Administered IV

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. 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.

Primary outcome measure(s)

Trial sites (196)

FacilityCityRegionStatus
Centro de Oncología e Investigación de Buenos Aires Berazategui Buenos Aires
Fundacion CENIT para la Investigacion en Neurociencias Caba Buenos Aires
Clinica Viedma Viedma Río Negro Province
Alexander Fleming Ciudad de Buenos Aires Argentina
Clínica El Castaño San Juan Argentina
Chris O'Brien Lifehouse Camperdown New South Wales
Calvary Mater Newcastle Waratah New South Wales
Westmead Hospital Westmead New South Wales
Monash Health Clayton Victoria
Peter MacCallum Cancer Centre Melbourne Victoria
St Vincent's Hospital Melbourne Victoria
Peninsula Oncology Centre Frankston Australia
UZ Brussel Brussels Bruxelles-Capitale, Région de
AZ Nikolaas Sint-Niklaas Oost-Vlaanderen
UZ Leuven Leuven Vlaams-Brabant
AZ Delta Roeselare West Flanders
UZ Gent Hospital Ghent Belgium
AZ Sint-Maarten, Campus Leopoldstraat 2 Mechelen Belgium
CHU UCL Namur/Site Sainte Elisabeth Namur Belgium
Hospital Sírio Libanês São Paulo Brazil
Núcleo de Oncologia da Bahia Salvador Estado de Bahia
Hospital de Cancer de Londrina Londrina Paraná
Grupo COI - Clínicas Oncológicas Integradas Rio de Janeiro Rio de Janeiro
Hospital São Lucas da PUCRS Porto Alegre Rio Grande do Sul
Fundação Pio XII - Hospital de Câncer de Barretos Barretos São Paulo
Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo São Paulo
Instituto Nacional de Câncer - INCA Rio de Janeiro Brazil
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA Rio de Janeiro Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo Brazil
Hospital Sírio Libanês São Paulo Brazil
Cross Cancer Institute Edmonton Alberta
Princess Margaret Cancer Centre Toronto Ontario
Beijing Cancer hospital Beijing Beijing Municipality
First affiliated Hospital of Sun Yat-Sen University Guangzhou Guangdong
The First Affiated Hospital Of Guangzhou Medical Collage Guangzhou Guangzhou
Harbin Medical University Cancer Hospital Harbin Heilongjiang
Wuhan Union Hospital Wuhan Hubei
Hunan Provincial People's Hospital Changsha Hunan
Hunan Cancer Hospital Changsha Hunan
Changzhou No.2 People's Hospital Changzhou Jiangsu

+ 156 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Eli Lilly and Company trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04194944 on ClinicalTrials.gov ↗ ← All trials in Turkey