本研究旨在探讨研究药物 selpercatinib 与安慰剂相比，在已接受手术或放射治疗的早期非小细胞肺癌（NSCLC）患者中，延缓癌症复发的疗效与安全性。被分配至安慰剂组并因疾病复发或恶化而停止使用研究药物的参与者，可选择交叉接受 selpercatinib 治疗。

适应症：Carcinoma, Non-Small-Cell Lung

入组条件

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:
weeks if no chemotherapy was administered
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.

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).

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。

Selpercatinib 用于非小细胞肺癌（NSCLC）患者手术或放射治疗后的研究