Status:
ACTIVE_NOT_RECRUITING
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Loxo Oncology, Inc.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (N...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04819100
Start Date
December 20 2021
End Date
April 1 2028
Last Update
December 29 2025
Active Locations (211)
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1
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States, 90404
2
Stockton Hematology Oncology Group
Stockton, California, United States, 95204
3
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
4
GenesisCare
Aventura, Florida, United States, 33180