Actively Recruiting
A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2023-11-27
62
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or older
- Confirmed diagnosis of locally advanced or metastatic NSCLC with RET fusion, including Stage IIIB-IIIC/IV not suitable for radical surgery
- RET gene fusion confirmed by central testing of tumor tissue
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 to 1
- Estimated life expectancy greater than 12 weeks
- Women of reproductive age agree to use contraception and not breastfeed during the study and for 6 months after last dose
- Men agree to use adequate contraception during the study and for 6 months after last dose
- Females with evidence of non-childbearing potential
- Signed informed consent form
You will not qualify if you...
- Previous or current treatment with selective RET inhibitors or multi-kinase RET inhibitors
- Prior systemic therapy for metastatic disease (adjuvant/neoadjuvant therapy allowed if completed at least 6 months before relapse)
- Local radiotherapy for palliation within 2 weeks before first dose, or more than 30% bone marrow irradiation, or large-scale radiotherapy within 4 weeks before first dose
- Major surgery within 4 weeks before first dose
- Inadequate bone marrow reserve or serious organ dysfunction
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Known, untreated, or active central nervous system metastases
- Active autoimmune or infectious diseases
- Severe nausea, vomiting, chronic gastrointestinal diseases, or inability to swallow oral medications
- History of severe allergic reaction or hypersensitivity to HS-10365 or similar drugs
- Unlikely to comply with study procedures or restrictions
- Safety concerns or interference with study assessments as judged by investigator
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of neuropathy or mental disorders including epilepsy and dementia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Shun Lu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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