Clinical trial NCT02388919 (phase 2/phase 3, status: completed)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: anlotinib, placebo
SMILES: [H][C@]12COC(=O)[C@]1([H])[C@H](C1=CC(OC)=C(O)C(OC)=C1)C1=CC3=C(OCO3)C=C1[C@H]2O[C@@H]1O[C@]2([H])CO[C@@H](C)O[C@@]2([H])[C@H](O)[C@H]1O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Signed and dated informed consent

          2. Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, with measurable
             nidus(using RECIST 1.1)

          3. at least two systematic chemotherapy with upwards of 3-line treatments or cannot
             suffer

          4. Patients must provide detectable specimen (from tumor tissue or hydrothorax) before
             participating, who negative in EGFR&ALK can participate or who positive in EGFR&ALK,
             have or have not drug tolerance after the treatment with relative targeted drugs

          5. ECOG PS：0-1,Expected Survival Time: Over 3 months

          6. main organs function is normal

          7. The woman patients of childbearing age who must agree to take contraceptive methods
             (e.g. intrauterine device, contraceptive pill or condom) during the research and
             within another 6 months after it; who are not in the lactation period and examined as
             negative in blood serum test or urine pregnancy test within 7 days before the
             research; The man patients who must agree to take contraceptive methods during the
             research and within another 6 months after it

        Exclusion Criteria:

          1. have used Anlotinib before

          2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed
             with non-small cell cancer)

          3. examined as positive in EGFR&ALK mutation detection and never take the treatment of
             TKIs

          4. central lung squamous carcinoma along with cavum, or non-small cell lung cancer along
             with hemoptysis (>50ml/day)

          5. other kinds of malignancies within 5 years or for now

          6. plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the
             medicine-taking period of this research, including Cytotoxic Therapy, Signal
             Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks
             before taking the treatment with experimental drug); The patients who have already
             taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited
             Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping

          7. have got non remissive toxic reactions derived from previous therapies, which is over
             level 1 in CTC AE (4.0), alopecia NOT included

          8. with kinds of factors which affect oral medicine (e.g. failing to swallow,
             gastrointestinal tract getting resected, chronic diarrhea and ileus)

          9. pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)

         10. symptoms of brain metastases cannot be controlled and treated within less than 2
             months

         11. get any severe diseases or the ones that cannot be controlled

         12. take major surgical treatments, open biopsy, or get overt traumatic injury within 28
             days before grouping

         13. have any habitus or medical history of hemorrhage, however severe it is; the patients
             who have non healing wounds, ulcer or fracture after any events with hemorrhage or
             bleeding (≥CTCAE level 3)

         14. get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents
             (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism

         15. ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental
             disorder

         16. have participated in other clinical trials of anti-tumor medicine within 4 weeks

         17. diagnosed with disease which will severely endanger the security of patients or
             influence the completion of this research.