A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lu… (NCT06147570) | Clinical Trial Compass
RecruitingPhase 2
A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
China62 participantsStarted 2023-09-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1.
✓. Estimated life expectancy \>12 weeks.
✓. 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.
✓. Females must have evidence of non-childbearing potential.
Exclusion criteria
✕. Treatment with any of the following:
✕. 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.
What they're measuring
1
ORR assessed by IRC
Timeframe: From the date of first occurrence of complete response (CR) or partial response (PR) on 2 consecutive occasions (≥4 weeks), until the date of disease progression or withdrawal from study, whichever came first, up to 48 months.
. Active autoimmune diseases or active infectious disease
✕. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.
✕. History of severe allergic reaction, hypersensitivity to any active or inactive ingredient of HS-10365 or to drugs with a similar chemical structure or class to HS-10365.
✕. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.