OncoMatch/Clinical Trials/NCT06461156
A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
Is NCT06461156 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies HS-10504 for locally advanced or metastatic nsclc.
Treatment: HS-10504 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR positive
evidence of EGFR-positive in tumor as determined by local or central testing
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: EGFR tyrosine kinase inhibitor
Progressive disease on or after prior treatment with EGFR-TKIs
Cannot have received: fourth-generation EGFR tyrosine kinase inhibitor
Prior or concurrent treatment with fourth-generation EGFR tyrosine kinase inhibitors
Cannot have received: cytotoxic chemotherapy
Exception: within 14 days prior to the first dose of HS-10504 or require continued treatment with these drugs during the study
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
Cannot have received: local radiotherapy
Exception: within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow prior to the first dose
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
Lab requirements
Blood counts
Inadequate bone marrow reserve [excluded]
Kidney function
Inadequate renal function [excluded]
Liver function
Inadequate hepatic function [excluded]
Inadequate bone marrow reserve or hepatic and renal functions [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06461156 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior fourth-generation EGFR tyrosine kinase inhibitor, cytotoxic chemotherapy, local radiotherapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR positive is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages