OncoMatch/Clinical Trials/NCT05948813
TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases
Is NCT05948813 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including TY-9591 and Osimertinib for nsclc.
Treatment: TY-9591 · Osimertinib — This study is to evaluate the efficacy and safety of TY-9591 in first-line treatment of patients with EGFR-sensitive mutation-positive non-small cell lung cancer with brain metastases compared to Osimertinib.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR activating mutation
Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites).
Required: EGFR exon 19 deletion
including exon 19 deletions
Required: EGFR L858R
including...L858R
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR inhibitor
Previous treatment with EGFR inhibitor
Cannot have received: systemic antitumor therapy
Previous treatment with Systematic antitumor therapy (including targeted therapy, biotherapy and immunodrug therapy, etc.)
Cannot have received: chemotherapy
Exception: standard chemotherapy within 28 days before the first dose of the study drug
Previous treatment with standard chemotherapy with 28 days before the first dose of the study drug
Cannot have received: traditional Chinese medicine antitumor therapy
Exception: within 7 days before the first dose of the study drug
traditional Chinese medicine antitumor therapy within 7 days before the first dose of the study drug
Cannot have received: radiation therapy
Exception: whole brain radiation therapy (WBRT) at any time; radiation to more than 30% of the bone marrow or wide field of radiation within 28 days of the first dose; limited field of radiation within 7 days of the first dose; palliative radiation therapy for bone metastasis
Previous whole brain radiation therapy (WBRT); Receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 28 days of the first dose of study treatment; Radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment or palliative radiation therapy for bone metastasis
Cannot have received: major surgery
Exception: within 28 days of the first dose of study treatment
Major surgery within 28 days of the first dose of study treatment
Cannot have received: other clinical trial therapy
Exception: within 28 days prior to the first administration of the investigational drug
Participants in other clinical trials (other than non-interventional clinical trials) within 28 days prior to the first administration of the investigational drug
Cannot have received: allogeneic bone marrow transplant
Previous allogeneic bone marrow transplant
Lab requirements
Blood counts
adequate bone marrow reserve function
Kidney function
no kidney dysfunction
Liver function
no liver dysfunction
Cardiac function
QTc ≤ 470 ms (from 3 ECGs); no clinically important abnormalities in rhythm; no factors that increase risk of QTc prolongation; LVEF ≥ 50%
Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction. Cardiac function and disease are consistent with the following: Corrected QT interval(QTc)> 470 milliseconds from 3 electrocardiograms (ECGs); Any clinically important abnormalities in rhythm; Any factors that increase the risk of QTc prolongation; Left ventricular ejection fraction (LVEF) <50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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