The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 administered
* 26 weeks if adjuvant chemotherapy was administered
* Eastern 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.
Exclusion Criteria:
* 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).
Primary outcome measure(s)
Event-Free Survival (EFS) — Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) EFS by Investigator Assessment in the Primary Analysis Population
Trial sites (211)
Facility
City
Region
Status
UCLA Hematology/Oncology - Santa Monica
Los Angeles
California
Stockton Hematology Oncology Group
Stockton
California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance
California
GenesisCare
Aventura
Florida
GenesisCare - Boca Raton
Boca Raton
Florida
USO-Cancer Care Center of Brevard, Inc.
Palm Bay
Florida
Dana-Farber Cancer Institute
Boston
Massachusetts
Mayo Clinic in Rochester, Minnesota
Rochester
Minnesota
USO-New York Oncology Hematology, P.C
Latham
New York
Memorial Sloan Kettering Cancer Center
New York
New York
USO - Alliance Cancer Specialists, PC
Horsham
Pennsylvania
Sarah Cannon Research Institute SCRI
Nashville
Tennessee
Tennessee Oncology Nashville
Nashville
Tennessee
USO-Texas Oncology-Central/South Texas
Austin
Texas
US Oncology
The Woodlands
Texas
Sunshine Coast University Hospital
Birtinya
Queensland
Rockhampton Hospital
Rockhampton
Queensland
The Townsville Hospital
Townsville
Queensland
Ballarat Health Services
Ballarat Central
Victoria
Bendigo Health Care Group
Bendigo
Victoria
Goulburn Valley Health
Shepparton
Victoria
South West Healthcare
Warrnambool
Victoria
Border Medical Oncology
Wodonga
Victoria
Landeskrankenhaus Feldkirch
Feldkirch
Vorarlberg
Klinik Floridsdorf
Vienna
Austria
Antwerp University Hospital
Edegem
Antwerpen
Cliniques universitaires Saint-Luc
Brussels
Bruxelles-Capitale, Région de
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
Yvoir
Namur
Clinique Saint Pierre
Ottignies
Wallonne, Région
AZ Delta vzw
Roeselare
West-Vlaanderen
CHU UCL Namur/Site Sainte Elisabeth
Namur
Belgium
Nucleo de Oncologia da Bahia
Salvador
Estado de Bahia
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul
Brasília
Federal District
Oncocentro de Minas Gerais
Belo Horizonte
Minas Gerais
Centro Oncológico do Triângulo
Uberlândia
Minas Gerais
Multihemo
Recife
Pernambuco
Hospital São Lucas da PUCRS
Porto Alegre
Rio Grande do Sul
Hospital BP
São Paulo
São Paulo
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo
São Paulo
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro
Brazil
+ 171 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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