Clinical trial NCT03169335 (phase 3, status: completed)
Conditions: non-squamous non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: ql1101, avastin®, paclitaxel, carboplatin
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥18 years and ≤75 years; 2) Patients with histologically or cytologically
             confirmed inoperable locally advanced (Stage IIIb, not suitable for multidisciplinary
             treatment), metastatic (Stage IV), or relapsed non-squamous cell non-small cell lung
             cancer. Diagnostic result of non-squamous cell non-small cell lung cancer obtained
             based on sputum cytology should be immunohistochemically confirmed. If a variety of
             tumor ingredients are mixed, the main cell types should be classified;

          -  ECOG score of 0-1 points;

          -  At least one measurable lesion can be evaluated according to RECIST1.1 criteria;
             Lesions situated in a previously irradiated area are considered measurable only if
             marked progressive signs occur after irradiation

          -  Patients who have not received systemic anti-tumor therapy of locally advanced or
             metastatic non-squamous non-small cell lung cancer (if the subject received adjuvant
             therapy after completing the radical treatment of early non-small cell lung cancer,
             but then the disease relapsed, the subject can be enrolled. In this case, the end time
             of the adjuvant therapy is required to be more than 6 months from the time of the
             first administration of this study, and various toxic reactions resulting from the
             adjuvant therapy should have recovered (≤ Grade 1 by CTCAE 4.03 criteria, except for
             alopecia).

          -  Expected survival time ≥24 weeks.

          -  Subjects must give informed consent to this study prior to the trial and voluntarily
             sign a written informed consent form.

        Exclusion Criteria:

          -  Central squamous cell carcinoma, and mixed gland squamous cell carcinoma with squamous
             cell as the main ingredient;

          -  ALK fusion gene is known to be positive;

          -  Medical history or examination shows thrombotic disease within 6 months prior to
             screening;

          -  Imaging shows signs of tumor invasion of large vessels, and the investigator or
             radiologist must exclude patients whose tumor has been completely close to or
             surrounded or invaded the lumen of large vessels (e.g., the superior pulmonary artery
             or superior vena cava);

          -  Patients with a past history of symptomatic brain metastases or meningeal metastases,
             or spinal cord compression;

          -  Patients who received palliative radiotherapy for bone lesions outside the chest
             within 2 weeks prior to the first dose of the study drug;

          -  Patients who received major surgical procedures (including thoracotomy), or suffered
             from major trauma (such as fractures) within 28 days prior to screening, or need to
             undergo major surgery during the expected study treatment period;

          -  Patients who received a minor surgical procedure within 48 hours prior to the first
             treatment with Anivitis®/QL1101 (the investigator judges whether there is bleeding
             tendency);

          -  Patients who are currently using or have recently used (within 10 days prior to the
             first dose of Avastin®/QL1101) aspirin (>325 mg/day) or other nonsteroidal
             antiinflammatory drugs known to inhibit platelet function, or full-dose
             anticoagulants;

          -  Patients whose medical history or examination shows hereditary bleeding tendency or
             coagulation disorders, which may increase the risk of bleeding; -Uncontrolled
             hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100
             mmHg);

          -  Patients who had a past history of hypertensive crisis or hypertensive encephalopathy;