Last updated 7 months ago
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
170 patients around the world
Available in Puerto Rico, Mexico, United States, Brazil, Spain
Loxo Oncology, Inc.
10Research sites
170Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 administered26 weeks if adjuvant chemotherapy was administeredEastern 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.
- 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).
Sites
Instituto Americas - COI
Recruiting
Centro Paulista de Oncologia
Recruiting
Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de Controle do Cancer - IBC
Recruiting
Núcleo de Oncologia da Bahia
Recruiting
Hospital Sírio- Libanês Brasilia
Cenatron Centro Avançado de Tratamento Oncológico
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Oncare Cancer Center Viaducto CdMx
Recruiting
Hospital Universitario Dr. José Eleuterio González
Recruiting
StudyLIBRETTO-432
SponsorLoxo Oncology, Inc.
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04819100
