A Study of Gimatecan (ST1481) in Small Cell Lung Cancer
A Study of Gimatecan (ST1481) in Small Cell Lung Cancer
This phase Ib/II clinical trial studies the safety and effect of Gimatecan in small cell lung
 cancer patients who failed the first-line standard platinum-containing chemotherapy. The
 chemotherapy will be given every four weeks.
Key Inclusion Criteria:

 1. Aged 18 to 75 years old of either gender;

 2. A histopathological or cytological diagnosis of small cell lung cancer(SCLC);

 3. Recurrence or progression disease after firstline platinum-containing chemotherapy and
 patients intolerant or unwilling to receive standard treatment;

 4. Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors
 (RECIST) v1.1;

 5. Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;

 6. Estimated life expectancy >4 months;

 7. Taking drugs orally;

 8. The function of important organs meets the following requirements:

 1. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥
 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;

 2. ALT, AST and AKP ≤ 2.5×ULN; liver metastasis: ALT、AST≤ 5.0×ULN, ALP ≤ 6.0×ULN;
 bone metastases ALT、AST≤ 2.5×ULN, ALP ≤ 5.0×ULN;

 3. serum albumin ≥ 30g/L;

 4. total bilirubin ≤ 1.5×ULN;

 5. serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min;

 6. INR ≤ 1.5, PT≤ 1.5×ULN;

 10. Serum HCG negative in premenopausal women, female patients of childbearing potential
 and male patients with female partners of childbearing potential must be willing to avoid
 pregnancy; 11. Ability to understand the study and sign informed consent.

 Key exclusion Criteria:

 1. Patients who have been treated previously for SCLC with two system chemotherapy
 (except for targeted therapy, immunotherapy and antiangiogenic therapy);

 2. Patients who have been treated previously with topotecan, Irinotecan or other
 topoisomerase I inhibitors;

 3. Known or suspected allergy or hypersensitivity to the investigational drug gimatecan
 ingredients or their analogues;

 4. Other anticancer therapy including any investigational agent within 28 days prior to
 the first dose of the investigational drug gimatecan;

 5. Patients who have been treated previously with intravenous or oral drugs that affect
 CYP isoenzymes within 7 days prior to the first dose of the investigational drug
 gimatecan;

 6. Brain metastasis or meningeal metastasis (except for asymptomatic patients with lesion
 stable more than 28 days);

 7. Major surgical intervention or trauma within 28 days prior to the first dose of
 investigational drug administration;

 8. A history of gastrointestinal disease which affects drug absorption;

 9. A history of allogeneic stem cell transplantation and organ transplantation;

 10. A history of interstitial lung disease or non-infectious pneumonia;

 11. Patients who cannot tolerate chemotherapy due to severe cardiac, lung, liver or kidney
 dysfunction, or hematopoietic disease or cachexia;

 12. A history of immunodeficiency (including a positive HIV test result), or other
 acquired or congenital immunodeficiency diseases;

 13. Presence of active hepatitis B (HBV DNA ≥ 200 IU/mL or 103 copies/mL), hepatitis C
 (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of
 the assay);

 14. A history of active pulmonary tuberculosis infection within 1 year or a history of
 active pulmonary tuberculosis infection more than 1 year ago but without formal
 anti-tuberculosis treatment;

 15. A history of malignancies other than esophageal cancer before enrollment, excluding
 non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;

 16. Pregnant or lactating women.