Clinical trial NCT02995187 (phase 2, status: unknown status)
Conditions: small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: apatinib mesylate tablet
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          1. 18 years to 75 years;

          2. Had a histologically or cytologically confirmed diagnosis of SCLC;

          3. Had received at least 2 lines chemotherapy regimen and must include basis of the
             platinum regimen after which disease diagnosed;

          4. Have not received VEGFR-TKI;

          5. Had a life expectancy of at least 3 months;

          6. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or
             2;

          7. Had a disease status that was measurable or evaluable as defined by Response
             Evaluation Criteria in Solid Tumors (RECIST, version1.1), larger than 10 mm in
             diameter by spiral CT scan;

          8. Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L,
             platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper
             limit of normal(ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum
             transaminase≤5×the ULN), serum creatine ≤ 1.25 x ULN, creatinine clearance rate >
             45ml/min;

          9. For women of child-bearing age, the pregnancy test results (serum or urine) within 7
             days before enrolment must be negative. They will take appropriate methods for
             contraception during the study until the 8th week post the last administration of
             study drug. For men (previous surgical sterilization accepted), will take appropriate
             methods for contraception during the study until the 8th week post the last
             administration of study drug;

         10. Signed and dated informed consent.Willingness and ability to comply with scheduled
             visits, treatment plans, laboratory tests, and other study procedure.

        Exclusion Criteria:

          1. Patients with non-small cell lung cancer;

          2. Imaging (CT or MRI) results indicate that the existence of central tumors locally
             invading the large vessel could be detected, or apparent pulmonary cavity or
             necrotizing tumors;

          3. Patients with clinical symptoms of brain metastases or meningeal metastasis;

          4. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg
             and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;

          5. Suffered from grade II or above myocardial ischemia or myocardial infarction,
             uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade
             III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria
             or echocardiography check: left ventricular ejection fraction (LVEF)<50%;

          6. Coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds
             or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and
             anticoagulation;

          7. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that
             the 24-h urine protein quantitation ≥ 1.0 g;

          8. Patients who received major surgical operations or experienced severe traumatic
             injuries, bone fracture, or ulcers within 4 weeks before screening;

          9. Patients who had obvious hemoptysis within 2 months before screening, or experienced
             daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above; Patients
             who experienced bleeding symptoms of clinical significance , or with confirmed
             bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer,
             baseline occult blood in stool ++ and above, or vasculitis, etc;

         10. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident
             (including transient ischemic attack), deep venous thrombosis and pulmonary embolism,
             etc., within 12 months before screening;

         11. Allergic to any ingredients of Apatinib;

         12. Evidence of significant medical illness that in the investigator's judgment will
             substantially increase the risk associated with the subject's participation in and
             completion of the study.