Clareo Health | Efficacy and Safety of Almonertinib Combined With Recombinant Human Endostatin in the Treatment of Stage IIIB-IV Non-small Cell Lung Cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Life expectancy of more than 3 months.
Willing and able to comply with the study protocol.
You may not be if
Known hypersensitivity to aumolertinib, recombinant human endostatin (Endostar), or other EGFR tyrosine kinase inhibitors (EGFR-TKIs).
Other malignant tumors, except basal cell carcinoma and carcinoma in situ.
Use of strong CYP3A4 inhibitors or inducers, or CYP substrates (e.g., CYP2C8, CYP2D6), within 7 days before the first dose of study drug.
Serious comorbidities or other medical conditions that may affect drug safety or study results, such as severe heart disease (including a documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina pectoris requiring medication, clinically diagnosed valvular heart disease, electrocardiographic evidence of prior severe myocardial infarction, and refractory hypertension), severe liver disease, or kidney disease.
Other anti-tumor treatment within the past 30 days, including but not limited to surgery, radiotherapy, chemotherapy, and immunotherapy (except concurrent radiotherapy for non-target lesions).
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× the upper limit of normal (ULN) in patients without liver metastases, or \>5×ULN in patients with liver metastases.
Serum creatinine \>1.5×ULN and creatinine clearance \<50 mL/min (Cockcroft-Gault formula); creatinine clearance needs to be confirmed only when serum creatinine \>1.5×ULN.
Left ventricular ejection fraction (LVEF) \<50%.
Abnormal coagulation (APTT \>1.5×ULN or INR \>1.5); current thrombolytic, anticoagulant, or antiplatelet therapy; or bleeding tendency or active bleeding (e.g., hemoptysis or gastrointestinal bleeding).
Arterial or venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism, within 6 months before enrollment.
History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease.
Pregnant or lactating women.
Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study.
