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Clinical Trials in India / NCT04819100
Active, not recruiting Phase 3

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

NCT04819100 · tracked via the Priya Life Science India tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2021-12-20
Last updated
2026-03-04

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

SelpercatinibPlacebo

Selpercatinib: Administered orally.

Placebo: Administered orally.

Study summary

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)

Trial sites (211)

FacilityCityRegionStatus
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.

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 NCT04819100 on ClinicalTrials.gov ↗ ← All trials in India