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 (May 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
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.
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