Relapsed or refractory small cell lung cancer that has failed previous platinum-based chemotherapy and anti-PD-1/PD-L1 monoclonal antibody treatment
Conditions
Interventions
Experimental arm:Paclitaxel polymeric micelles combined with ivonescimab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form and follow the protocol requirements; 2. Age >= 18 years; 3. Expected survival time >= 3 months; 4. Patients with recurrent small cell lung cancer confirmed by histology or cytology who have failed platinum-containing chemotherapy and PD-1/PD-L1 monoclonal antibody therapy; 5. Must have at least one measurable lesion according to RECIST v1.1 criteria; 6. ECOG performance status score of 0 or 1; 7. Toxicities from previous anti-tumor treatments have recovered to = 50%; 9. Key organ functions must meet the following standards: (1) Bone marrow function: absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 90 g/L; (2) Liver function: total bilirubin (TBIL) = 50 mL/min (according to Cockcroft and Gault formula); (4) Coagulation: International Normalized Ratio (INR) = 50%; 10. Women of childbearing potential must have a serum pregnancy test within 7 days before starting treatment, which must be negative, and must not be breastfeeding; all participants must use effective barrier contraception throughout the treatment period and for 6 months after finishing treatment.
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity to polymer micelle or paclitaxel and ivoximab, with active or non-active excipients, or to drugs with similar structures or classes to the investigational drug; 2. Previous systemic treatment with taxane drugs and/or anti-vascular endothelial growth factor (VEGF) monoclonal antibodies; 3. Patients who received any of the following treatments prior to the first administration of the study drug: (1) Major surgery has been performed within 28 days prior to the first administration of the study drug (in China, the definition of major surgery refers to Level 3 and Level 4 surgeries as stipulated in the 'Administrative Measures for Clinical Application of Medical Technology' effective May 1, 2009; see Appendix 5 for details); (2) Within 4 weeks prior to the first administration of the study drug or within 5 half-lives (whichever is shorter), have used chemotherapy, targeted therapy, biologics, immunotherapy, radical radiotherapy, major surgery, or large-area radiotherapy (bone marrow radiotherapy exceeding 30% or extensive irradiation has been performed), used small-molecule targeted therapy (including small molecule tyrosine kinase inhibitors) within 5 days, or used palliative radiotherapy within 2 weeks (but palliative radiotherapy for bone lesions is permitted); (3) Patients who have received cytochrome P450 3A enzyme (CYP3A) and CYP2C enzyme inhibitors or inducers within 7 days prior to the first administration of the study drug, or who require continued treatment with these drugs during the study period (see Appendix 6 for the list of medications); (4) Patients who have received TCM or proprietary Chinese medicine preparations indicated for antitumor treatment within 7 days prior to the first administration of the study drug, or who require continued treatment with these drugs during the study period (see Appendix 7 for the list of drugs); (5) Patients currently receiving medications known to prolong the QT interval or may cause torsion of the tip ventricular tachycardia, and who require continued treatment during the study period (see Appendix 8 for the list of medications); 4. Presence of spinal cord compression or symptomatic central nervous system (CNS) metastasis; Except for asymptomatic patients who did not require steroid treatment for 14 days or more prior to the first administration of the investigational drug; Patients who have received local radiotherapy for CNS metastases must be enrolled after CNS metastasis symptoms have stabilized for at least 14 days after radiotherapy ends; 5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Imaging studies show that the tumor has invaded or enveloped major vessels in the abdomen, chest, neck, or pharynx, except where investigators believe it does not affect patient enrollment and medication; 7. Subjects with clinically obvious bleeding or obvious bleeding tendency within 3 weeks prior to signing the informed consent form, such as hemoptysis (defined as bright red blood or up to half a teaspoon), gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; 8. Patients with inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, etc.), history of extensive bowel resection, history of immune enteritis, presence of intestinal obstruction, chronic diarrhea, or Gilbert's syndrome; 9. Having had other malignant tumors or a history of other malignancies within the past 5 years, e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);adverse event; | — |
Countries
China
Contacts
Public ContactShaodong Hong
Sun Yat-sen University Cancer Center
Outcome results
None listed