本研究旨在观察研究药物selpercatinib与标准治疗相比，在已扩散至身体其他部位的RET融合阳性非鳞状非小细胞肺癌（NSCLC）参与者中是否有效及安全。被分配至标准治疗且因疾病进展而停药的参与者，可选择交叉接受selpercatinib治疗。
适应症：Non-Small Cell Lung Cancer
入组条件
纳入标准
- Histologically or cytologically confirmed, Stage IIIB-IIIC or Stage IV non-squamous NSCLC that is not suitable for radical surgery or radiation therapy.
- A RET gene fusion in tumor and/or blood from a qualified laboratory.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- 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 treatment and for 6 months after.
- Ability to swallow capsules.
排除标准
- Additional validated oncogenic drivers in NSCLC if known.
- Prior systemic therapy for metastatic disease. Treatment (chemotherapy, immunotherapy, or biological therapy) in the adjuvant/neoadjuvant setting is permitted if it was completed at least 6 months prior to randomization.
- Major surgery within 3 weeks prior to planned start of selpercatinib.
- Radiotherapy for palliation within 1 week of the first dose of study treatment or any radiotherapy within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung.
- Symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or untreated spinal cord compression.
- Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds.
- Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
- Pregnancy or lactation.
- Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed ≥2 years previously and not currently active.
- Uncontrolled, disease related pericardial effusion or pleural effusion.
- Requiring chronic treatment with steroids.
- History of interstitial lung disease or interstitial pneumonitis.
- Active autoimmune disease or any illness or treatment that could compromise the immune system.
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。