A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Men or women aged more than or equal to (≥) 18 years. 2. 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. 3. A RET gene fusion is required by using tumor tissue for central testing. 4. At least one measurable lesion in accordance with RECIST 1.1 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1. 6. Estimated life expectancy \>12 weeks. 7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit. 8. Females must have evidence of non-childbearing potential. 9. Signed and dated Informed Consent Form. Exclusion Criteria: 1. Treatment with any of the following: Additional validat