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)
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab) — Baseline to Progressive Disease or Death from Any Cause Up to 31 Months PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease.
PFS by BICR (With or Without Pembrolizumab) — Baseline to Progressive Disease or Death from Any Cause Up to 31 Months PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease.
Trial sites (196)
Facility
City
Region
Status
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.
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.
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