Third-line advanced non-small cell lung cancer (NSCLC) after prior treatment failure
Conditions
Interventions
Intervention Group:Utidelone + Anlotinib Chemotherapy Regimen
Sponsors
Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients with histologically and/or cytologically confirmed advanced non-small cell lung cancer who have failed or are intolerant to standard therapy (second-line chemotherapy for advanced disease); EGFR mutation-positive patients must have received at least one or more EGFR-TKIs (including but not limited to erlotinib, gefitinib, icotinib, afatinib, osimertinib, or other TKIs targeting EGFR mutations) and experienced disease progression or intolerance during or after treatment; ALK fusion-positive patients must have received at least one or more ALK-TKIs and experienced disease progression or intolerance during or after treatment; 2.According to RECIST 1.1, at least one measurable target lesion must be present; 3.Aged 18 to 70 years, with no gender restrictions. 4.ECOG performance status score of 0 to 2; 5.With a life expectancy of >=3 months; 6.Within 1 week prior to grouping, hematology parameters must meet the following criteria (without transfusion or hematopoietic growth factor support within 14 days): Absolute neutrophil count (ANC) >=1.5×10^9/L Hemoglobin (Hb) >=90 g/L Platelet count (PLT) >=75×10^9/L; 7.Within 1 week prior to enrollment, liver and kidney function tests must meet the following criteria (based on the reference ranges of each study center's laboratory): Total bilirubin (TBIL) = 50 mL/min; 8.Eligible patients of childbearing potential (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the trial and for at least 3 months after the last dose. Female patients of childbearing age must have a negative blood or urine pregnancy test before enrollment; 9.Female patients of childbearing potential must provide confirmed negative blood or urine test results and commit to using effective contraception during the study and for 6 months after its conclusion. Male patients must commit to ensuring that both they and their spouses/female partners use effective contraception during the study and for 6 months after its conclusion; 10.The patient is capable of understanding the study requirements, can cooperate with the physician for scheduled follow-ups, demonstrates good compliance, and is willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients suitable for curative-intent treatment; 2.Has undergone major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose of the investigational drug; 3.Has received radiotherapy, chemotherapy, targeted therapy, or immune checkpoint inhibitor therapy within 2 weeks prior to the study initiation; 4.Adverse reactions from previous antitumor treatments have not recovered to CTCAE 5.0 Grade =1, and symptomatic peripheral neuropathy from prior regimens is CTCAE 5.0 Grade >=2. 5.Patients with symptomatic central nervous system metastases or leptomeningeal metastases, or any other evidence indicating that the CNS metastases or leptomeningeal metastases are not controlled, and who are deemed by the investigator as unsuitable for enrollment; 6.A history of severe hypersensitivity to castor oil; 7.Pregnancy (positive pregnancy test) or lactation; 8.Patients with severe, uncontrolled organic diseases or infections, such as decompensated cardiac, pulmonary, or renal failure, that render them unable to tolerate chemotherapy; 9.Patients with severe hemorrhagic tendency; 10.Individuals with mental disorders or poor adherence; 11.Any other systemic medical history considered by the investigator as unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Progression-free survival time(PFS);Disease Control Rate(DCR); | — |
Countries
China
Contacts
Public ContactZemei Xu
Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed