NSCLC
Conditions
Interventions
Dose Escalation Phase:1. This study employs a "3+3" dose-escalation design to evaluate the occurrence of dose-limiting toxicities (DLT) across different dose cohorts (200 mg bid, 400 mg bid, 600 mg bi
?2) If more than 1 out of the total 6 subjects experiences DLT (i.e., >=1 DLT in the latter 3 subjects), dose escalation will be stopped, and the investigators will discuss whether to terminate the co
?2) If 1 subject experiences DLT, an additional 3 subjects will be enrolled, forming a cohort of 6 subjects:
??(1) If 1 subject experiences DLT in total (i.e., >=1 DLT in the latter 3 sub
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Having received at least first-line and second-line standard therapies, with disease progression after standard treatment or intolerance to the aforementioned therapies, regardless of the driver gene mutation status; 2. Aged >= 18 years, regardless of gender; 3. Subjects with histologically or cytologically confirmed locally advanced and/or advanced non-small cell lung cancer (NSCLC); 4. Subjects with at least one measurable lesion as defined by RECIST (Version 1.1); 5. ECOG Performance Status (PS): 0 – 1; 6. Able to independently and voluntarily sign the informed consent form, and capable of completing follow-up examinations, assessments, and treatments, with an expected survival time of >= 3 months; 7. Normal function of major organs (no blood transfusion or blood products, no use of hematopoietic stimulants, and no use of albumin or blood products within 14 days prior to the first dose): (1) Bone marrow function: Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L, Platelets (PLT) >= 75 × 10^9/L, and Hemoglobin (Hb) >= 9 g/dL; (2) Liver function: Total Bilirubin (TBIL) 50 mL/min (calculated by the Cockroft-Gault formula); Urine Protein = 2+, a 24-hour urine protein test is required, and subjects with a total amount < 1 g are eligible for enrollment); 8. Female subjects of childbearing age must agree to use contraceptive measures (e.g., intrauterine device, contraceptives, or condoms) during the study and within 6 months after the study ends; not breastfeeding, and serum or urine pregnancy test within 7 days prior to the study is negative; male subjects must agree to use contraceptive measures during the study and within 6 months after the study ends.
Exclusion criteria
Exclusion criteria: 1. Small cell carcinoma and other cancers mixed with non-small cell carcinoma; 2. Active or symptomatic central nervous system (CNS) metastases; 3. Other active malignant tumors requiring treatment; 4. Patients with prior exposure to anti-angiogenic tyrosine kinase inhibitor (TKI) therapy; 5. Prior intolerance or allergy to any component of the planned treatment regimen in this study or to drugs of the same class; 6. Patients who have undergone major surgical treatment or suffered severe trauma before randomization, or whose surgical/traumatic effects have not resolved for less than 14 days; 7. Patients with active or uncontrolled severe infections; 8. Patients with unhealed wounds or fractures; 9. Various factors affecting oral medication administration (e.g., inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction); 10. Patients with any of the following cardiac conditions: (1) Left Ventricular Ejection Fraction (LVEF) 450 msec; (4) Other cardiac diseases deemed unsuitable for enrollment by the investigator; 11. Planned receipt of systemic anti-tumor therapy (including cytotoxic therapy, signal transduction inhibitors, and immunotherapy) within 4 weeks prior to randomization or during the medication period of this study; 12. Patients with liver cirrhosis, decompensated liver disease, or active hepatitis; patients with hemorrhagic disorders or coagulation dysfunction; 13 Diagnosis of diseases that severely endanger patient safety or affect the completion of this study; 14. Pregnant or lactating women, or those planning to become pregnant or have children during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Overall response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactWang Yingyi
Peking Union Medical College Hospital
Outcome results
None listed