Small Cell Lung Cancer
Conditions
Interventions
safety run-in:Observe the safety and tolerability of irinotecan liposomes (II) at 100mg/m2. If = 1 case of dose limiting toxicity (DLT) occurs, it enters the main research stage.
Cohort A: irinotecan liposome (II) and famitinib treatment group:Irinotecan liposomes (II) 100mg/m2, IV, D1, Q3W, and famitinib 20mg po qd
Cohort B: Irinotecan liposomes (II) and investigator-selected platinum-based chemotherapy treatment group:Irinotecan liposomes (II) 100mg/m2, IV, D1, Q3W and platinum chemotherapy chosen by the resear
Cohort C: irinotecan liposome therapy group:Irinotecan liposomes (II) 100mg/m2, IV, D1, Q3W
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. All subjects must sign an informed consent form (ICF) before starting any study-related procedures. 2. Age: 18-75 years, regardless of gender. 3. ECOG performance status: 0-1. 4. Histologically or cytologically confirmed extensive-stage small cell lung cancer (according to the 8th edition TNM staging criteria of the International Association for the Study of Lung Cancer (IASLC) or VALG staging). 5. Progression after first-line immunotherapy. 6. At least one measurable target lesion on imaging evaluation (enhanced CT or MRI) within 4 weeks prior to enrollment (according to RECIST 1.1). 7. Asymptomatic or treated stable central nervous system (CNS) metastases must meet the following criteria: No radiological progression for at least 4 weeks after completion of treatment. Completion of treatment within 4 weeks prior to enrollment. No requirement for systemic corticosteroid therapy (>10mg/day prednisone or equivalent) within 2 weeks prior to enrollment. 8. Expected survival period =12 weeks. 9. Vital organ function within the following criteria within 1 week prior to enrollment (no blood transfusion or blood products in the past 14 days, no use of G-CSF or other hematopoietic stimulating factors for correction): Hematology: WBC = 3.0 × 10^9/L; ANC = 1.5 × 10^9/L; PLT = 100 × 10^9/L; HGB = 90g/L. Liver function: AST = 2.5 × ULN, ALT = 2.5 × ULN, ALT and AST = 5 × ULN for subjects with liver metastases; TBIL = 1.5 × ULN (except for Gilbert's syndrome = 3 × ULN); ALB = 30.0g/L. Renal function: Serum creatinine = 1.5 × ULN or CrCl = 50 mL/minute (using Cockcroft/Gault formula). Coagulation function: INR = 1.5, APTT = 1.5 × ULN. Thyroid stimulating hormone (TSH) = upper limit of normal (ULN); if abnormal, T3 and T4 levels should be investigated, and subjects with normal T3 and T4 levels may be eligible. Other: Lipase = 1.5 × ULN, subjects with lipase > 1.5 × ULN without clinical or radiological evidence of pancreatitis may be eligible; Amylase = 1.5 × ULN, subjects with amylase > 1.5 × ULN without clinical or radiological evidence of pancreatitis may be eligible; ALP = 2.5 × ULN, ALP = 5 × ULN for subjects with bone metastases; Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) = 50%. 10. Female subjects of childbearing potential must have a negative serum HCG test within 7 days before the first dose of medication, and must be non-lactating, and agree to use appropriate contraceptive measures (such as intrauterine devices, contraceptive pills, or condoms) during the study treatment period and for 3 months after the last dose of famitinib or 6 months after the last dose of Icaritin Liposomes (II) (whichever is longer). For male subjects with partners of childbearing potential, surgical sterilization or agreement to use appropriate contraceptive methods during the study treatment period and for 3 months after the last dose of famitinib/Icaritin Liposomes (II) (whichever is longer) is required.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are not eligible for inclusion in this study: 1. Pathological diagnosis of NSCLC or mixed type of SCLC and NSCLC by tissue or cell pathology; 2. Previously received two or more lines of treatment; 3. Previously received treatment with topoisomerase I inhibitor regimen; 4. Previously used anti angiogenic drugs such as bevacizumab, recombinant human endostatin, anlotinib, apatinib, etc; 5. Radiation therapy for the chest and whole brain should be completed within 4 weeks before enrollment (palliative radiation therapy for bone lesions should be completed before the first dose of the study drug and enrollment is allowed); 6. Except for hair loss and fatigue, other toxicity caused by previous anti-tumor treatments did not recover to CTCAE 5.0 = 1 level before enrollment. Other toxicity caused by previous anti-tumor treatments that cannot be resolved within the expected timeframe and have long-term persistent sequelae; 7. Patients with active brain metastases or meningeal metastases who have undergone treatment for brain metastases must meet the following conditions before enrollment: no MRI evidence of progression for = 4 weeks after treatment, and treatment completed within = 28 days before the first dose of study drug; Treatment with systemic corticosteroids (>10mg/day prednisone or equivalent dose) is not required for = 14 days before the first dose of the investigational drug; 8. Patients with spinal cord compression that cannot be cured or relieved after surgery and/or radiation therapy, or those who have previously been diagnosed with spinal cord compression and have compressive paraplegia or paraplegia after treatment; 9. Patients with liver metastasis who receive cryoablation and radiofrequency ablation treatment still have significant clinical symptoms and abnormal liver function within the first 4 weeks of enrollment; 10. There is a large amount of uncontrollable pleural effusion, pericardial effusion, or ascites; 11. Existence of the following cardiac diseases: (1) According to NYHA heart function classification, heart function level III-IV; (2) Unstable angina or electrocardiogram indicating acute ischemia or myocardial infarction within 1 year; (3) Clinically significant conduction system abnormalities such as supraventricular or ventricular arrhythmias (including QTc interval greater than or equal to 450ms for males and = 470ms for females); (4) Clinically significant pericardial and myocardial diseases; 12. Within 4 weeks prior to enrollment, systemic immunomodulators (including but not limited to thymosin, interferon, or interleukin-2) were used for treatment; 13. Have any history of active autoimmune diseases or autoimmune diseases; Interstitial pneumonia, drug-induced pneumonia, radiation pneumonia requiring steroid treatment (greater than 10mg/day prednisone or its equivalent dose), or active pneumonia with clinical symptoms; 14. Active or uncontrollable severe infection (CTCAE 5.0 = grade 2) within 2 weeks prior to enrollment, and/or receiving antibiotic treatment; 15. Active or receiving treatment for pulmonary tuberculosis patients; 16. People with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, untreated active hepatitis B (HBsAg positive or HBV DNA = 500 IU/ml and abnormal liver function), hepatitis C (hepatitis C antibody positive, HCV-RNA higher than the detection limit of the analytical method and abnormal liver function)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month progression free survival rate;Overall survival, OS;Objective Response Rate, ORR;Disease control rate, DCR;Duration of relief, DOR;Safety ; | — |
Countries
China
Contacts
Public ContactYan Wang
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed