Actively Recruiting
A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-09-17
230
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.
CONDITIONS
Official Title
A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Disease progression after prior treatment with EGFR tyrosine kinase inhibitors
- Evidence of EGFR-positive tumor by local or central testing
- At least one target lesion measurable by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance status score of 0 or 1
- Estimated life expectancy greater than 12 weeks
- Use of adequate contraception throughout the study for men and women
- Women must be non-childbearing or have evidence of non-childbearing potential
- Signed and dated informed consent form
You will not qualify if you...
- Presence of oncogenic driver genes other than EGFR
- Mixed cell histology or phenotypic transformation
- Prior or current treatment with fourth-generation EGFR tyrosine kinase inhibitors
- Cytotoxic chemotherapy, investigational drugs, traditional Chinese medicine with anti-tumor effects, or other anti-tumor drugs within 14 days before starting HS-10504 or requiring ongoing use during the study
- Local radiotherapy within 2 weeks before starting study treatment or prior irradiation of more than 30% of bone marrow
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Major surgery within 4 weeks before starting treatment
- Symptomatic or active progression of central nervous system metastases
- Residual toxicities of grade 2 or higher from previous therapies
- History of other primary cancers
- Inadequate bone marrow, liver, or kidney function
- Severe or poorly controlled diabetes, cardiovascular diseases, hypertension, severe thrombotic events, severe infections, significant bleeding, or serious gastrointestinal problems
- Hypersensitivity to any component of HS-10504
- Moderate to severe lung diseases
- Significant neurological or mental disorders
- Women who are breastfeeding, pregnant, or planning pregnancy during the study
- Unlikely to comply with study procedures, restrictions, or requirements
- Any condition that may compromise safety or interfere with study assessments according to the investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Actively Recruiting
Research Team
J
Jianxing He, PhD
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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