Status:
RECRUITING
A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Nonsmall Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
Detailed Description
This is an open-label, single arm, multi-center Phase 2 study in participants with treatment-naïve locally advanced or metastatic RET fusion-positive non-small cell lung cancer, which is designed to i...
Eligibility Criteria
Inclusion
- 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.
- Signed and dated Informed Consent Form.
Exclusion
- Treatment with any of the following:
- Additional validated oncogenic drivers in NSCLC if known. Previous or current treatment with selective RET inhibitors or multi-kinase Inhibitor of RET.
- Prior systemic therapy for metastatic disease. Treatment (including chemotherapy or immunotherapy) in the adjuvant/neoadjuvant setting is permitted if it was completed at least 6 months prior to relapse.
- Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
- 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
- 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.
- The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
- Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
- History of neuropathy or mental disorders, including epilepsy and dementia
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06147570
Start Date
September 25 2023
End Date
August 31 2028
Last Update
November 27 2023
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China