Clinical trial NCT03256721 (phase 2, status: terminated)
Conditions: nonsmall cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: apatinib/docetaxel/pemetrexed, docetaxel/pemetrexed
SMILES: [H][C@@]12C[C@H](O)[C@@]3(C)C(=O)[C@H](O)C4=C(C)[C@H](C[C@@](O)([C@@H](OC(=O)C5=CC=CC=C5)[C@]3([H])[C@@]1(CO2)OC(C)=O)C4(C)C)OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C1=CC=CC=C1, [H][C@@]12C[C@H](O)[C@@]3(C)C(=O)[C@H](O)C4=C(C)[C@H](C[C@@](O)([C@@H](OC(=O)C5=CC=CC=C5)[C@]3([H])[C@@]1(CO2)OC(C)=O)C4(C)C)OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C1=CC=CC=C1
Reason stopped: 
    due to the enrollment was slow and exceeded the expected enrollment time
  
Eligibility criteria:

        Inclusion Criteria:

          1. Age：18~75 years;

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          3. Subjects with histologically or cytologically confirmed locally advanced or advanced
             NSCLC who have previously received no more than one lines treatment before
             participating；

          4. Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which
             is confirmed by computed tomography (CT) scan or MRI .

          5. EGFRˉ,and ALK mutation in the negative or unknown；

          6. Subjects without brain metastases or asymptomatic brain metastases, and not needing
             for dehydrating agents or corticosteroids to control intracranial symptoms;

          7. Survival expectation≥ 3 months;

          8. The main organ function is normal;

          9. Females of childbearing potential must be a pregnancy test in 7 days before
             participating ( including serum or urine), and the results were negative.

         10. Subjects provided written informed consent before participating,Willing and able to
             comply with all aspects of the protocol

        Exclusion Criteria:

          1. Small Cell Lung Cancer;

          2. Subjects with symptomatic brain metastases;

          3. Survival expectation < 3 months;

          4. Blood transfusion is required in the first dose of drug treatment within 14 days ;

          5. The interval of subjects had received chemotherapy, biotherapy, radiotherapy or other
             anticancer therapies in the first dose of drug treatment within 21 days(excluding
             palliative radiotherapy);

          6. The risk of active bleeding;

          7. Subjects with uncontrolled blood pressure with medication (140/90 mmHg)

          8. Laboratory values and organ functions ： （1）Hematologic insufficiency:

               1. Hemoglobin (Hb)<8.5 g/dL，

               2. Absolute neutrophil count (ANC)≤1.5×109/L，

               3. Platelet count (PLT)< 100×109/L； （2）Insufficient liver function:

               1. Bilirubin > 1.5×the upper limit of normal (ULN)

               2. Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) >3.0×(ULN),
                  When liver metastases,Bilirubin > 1.5×ULN, ALT or AST >5.0×(ULN.

               3. serum creatinine ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per
                  the Cockcroft and Gault formula) (3) Subjects with positive for HBV
                  surfaceantigen ( HBsAg)or anti-hcv (4)Subjects with Interstitial lung disease
                  (5)Insufficient renal function: serum creatinine≥ 1.5×（ULN）, or creatinine
                  clearance <60 mL/min

          9. impairment of heart function: (1)Left ventricular ejection fraction (LVEF) <45% (LVEF
             evaluation is not required for subjects have no history of congestive heart failure),
             (2)Unstable angina, (3)Severe arrhythmia, (4)NYHA III or IVgrade of congestive heart
             failure, (5) Subjects with miocardial infarction within the last 12 months before
             entering the trial, (6)Pericardial effusion,

         10. Subjects with liver fibrosis or hepatic cirrhosis

         11. (1)Subjects with other active malignancy (except for definitively treated non melanoma
             skin cancer,carcinoma in-situ of the cervix,or other cancers that are treated with
             curative treatment and have no signs of recurrence for at least 5 years ) ,
             (2)Subjects with dysphagia,malabsorption,chronic gastrointestinal diseases,or other
             medical history may hinder compliance and / or experimental drug absorption,

         12. Subjects with major surgery in the first dose of drug treatment within 28 days,

         13. Subjects with positive foknown human immunodeficiency virus。