Active Not RecruitingPhase 3NCT04819100

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

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.

Checked against the public recordLast updated Mar 4, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations211
SponsorEli Lilly and Company
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: Selpercatinib; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UCLA Hematology/Oncology - Santa MonicaLos Angeles, California
  • Stockton Hematology Oncology GroupStockton, California
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, California
  • GenesisCareAventura, Florida
  • GenesisCare - Boca RatonBoca Raton, Florida
  • USO-Cancer Care Center of Brevard, Inc.Palm Bay, Florida
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • Mayo Clinic in Rochester, MinnesotaRochester, Minnesota
  • USO-New York Oncology Hematology, P.CLatham, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • USO - Alliance Cancer Specialists, PCHorsham, Pennsylvania
  • Sarah Cannon Research Institute SCRINashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 4, 2026. Always confirm current availability with the study team.

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