OncoMatch/Clinical Trials/NCT05435248
Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
Is NCT05435248 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies HS-10375 for advanced or metastatic nsclc.
Treatment: HS-10375 — HS-10375 is an oral, highly selective, small molecular inhibitor of EGFR C797S. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10375 in Chinese advanced or metastatic NSCLC.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR C797S inhibitor
Previous or current treatment with EGFR C797S inhibitors
Cannot have received: cytotoxic chemotherapy
Exception: within 14 days of the first dose of HS-10375
Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10375
Cannot have received: targeted small molecule inhibitor
Exception: within 14 days of the first dose of HS-10375
Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10375
Cannot have received: investigational agent
Exception: within 28 days of the first dose of HS-10375
Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10375
Cannot have received: large molecule antibody
Exception: within 28 days of the first dose of HS-10375
Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10375
Cannot have received: local radiotherapy
Exception: for palliation within 2 weeks of the first dose of HS-10375, or more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks
Local radiotherapy for palliation within 2 weeks of the first dose of HS-10375, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10375
Cannot have received: major surgery
Exception: within 4 weeks of the first dose of HS-10375
Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10375
Lab requirements
Blood counts
adequate bone marrow reserve required
Inadequate bone marrow reserve or serious organ dysfunction
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05435248 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR C797S inhibitor, cytotoxic chemotherapy, targeted small molecule inhibitor disqualifies patients from 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