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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT04819100

Run by

Eli Lilly and Company

People needed

152

Starts

2021-12-20

Expected to finish

2028-05-01

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Stockton Hematology Oncology Group — Stockton, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• GenesisCare — Aventura, Florida, United States
• GenesisCare - Boca Raton — Boca Raton, Florida, United States
• USO-Cancer Care Center of Brevard, Inc. — Palm Bay, Florida, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States
• USO-New York Oncology Hematology, P.C — Latham, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• USO - Alliance Cancer Specialists, PC — Horsham, Pennsylvania, United States
• Sarah Cannon Research Institute SCRI — Nashville, Tennessee, United States
• Tennessee Oncology Nashville — Nashville, Tennessee, United States
• USO-Texas Oncology-Central/South Texas — Austin, Texas, United States
• US Oncology — The Woodlands, Texas, United States
• Sunshine Coast University Hospital — Birtinya, Queensland, Australia
• Rockhampton Hospital — Rockhampton, Queensland, Australia
• The Townsville Hospital — Townsville, Queensland, Australia
• Ballarat Health Services — Ballarat Central, Victoria, Australia
• Bendigo Health Care Group — Bendigo, Victoria, Australia
• Goulburn Valley Health — Shepparton, Victoria, Australia
• South West Healthcare — Warrnambool, Victoria, Australia
• Border Medical Oncology — Wodonga, Victoria, Australia
• Landeskrankenhaus Feldkirch — Feldkirch, Vorarlberg, Austria
• Klinik Floridsdorf — Vienna, Austria
• UCLA Hematology/Oncology - Santa Monica — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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