HS-10365 is a small molecular, oral potent, selective RET inhibitor. The purpose of this study is to investigate the efficacy and safety of HS-10365 in Chinese advanced RET fusion-positive non-small cell lung cancer patients without any systemic therapy.
Men or women aged more than or equal to (≥) 18 years.
Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC with RET fusion-positive, including recurrent or initial diagnosed Stage IIIB-IIIC/IV NSCLC that is not suitable for radical surgery.
A RET gene fusion is required by using tumor tissue for central testing.
At least one measurable lesion in accordance with RECIST 1.1
Inadequate bone marrow reserve or serious organ dysfunction.
Uncontrolled pleural effusion or ascites or pericardial effusion.
Known and untreated, or active central nervous system metastases.
Active autoimmune diseases or active infectious disease