Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT06461156
Eligibility Criteria:
Inclusion Criteria:
* Males or females, aged ≥ 18 years.
* Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC
* Progressive disease on or after prior treatment with EGFR-TKIs.
* Enrollment will be restricted to participants with evidence of EGFR-positive in tumor as determined by local or central testing.
* At least 1 target lesion according to RECIST 1.1.
* ECOG PS score: 0-1.
* Estimated life expectancy\> 12 weeks.
* Men or women should be using adequate contraceptive measures throughout the study.
* Women must have the evidence of non-childbearing potential.
* Signed and dated Informed Consent Form.
Exclusion Criteria:
* Subjects with known oncogenic driver genes other than EGFR.
* Subjects with mixed cell histologic or with phenotypic transformation.
* Treatment with any of the following:
1. Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors.
2. Cytotoxic chemotherapy, any other investigational drugs, traditional Chinese medicine with anti-tumor indications, or other anti-tumor drugs within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study.
3. Any local radiotherapy 2 weeks prior to the first dose of study treatment; have received irradiation of more than 30% of bone marrow prior to the first dose
4. Uncontrolled pleural effusion or ascites or pericardial effusion.
5. Major surgery within 4 weeks before the first dose.
6. CNS metastases with symptomatic or active progression.
* Subjects who have any grade ≥2 residual toxicities from prior therapies.
* Subjects who have history of other primary malignancies.
* Inadequate bone marrow reserve or hepatic and renal functions.
* Subjects with severe or poorly controlled diabetes, cardiovascular diseases or hypertension; subjects with severe arteriovenous thrombotic events, severe infection, clinically significant bleeding symptoms or clinically significant gastrointestinal dysfunction.
* Hypersensitivity to any ingredient of HS-10504.
* Moderate to severe pulmonary diseases.
* Prior history of significant neurological or mental disorders.
* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06461156
Study Brief:
Protocol Section:
NCT06461156