Eligible patients will enter the screening period up to 28 days before the start of treatment. Patients will be randomized in a 1:1 ratio to receive HB1801 (trial group) or Taxotere (control group). Randomized stratification factor is pathological type (squamous vs. non-squamous). Patients in trial group will receive HB 1801 and patients in control group will receive Taxotere. HB 1801 or Taxotere will be given on the first day of each cycle (21 days). Each patient will be treated until documented disease progression, discontinuation due to toxicity, withdrawal of consent, initiation of a new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first.
This is an open-label, randomized, positive drug-controlled Phase Ⅱ clinical study to compare the efficacy and safety of HB1801 to Taxotere in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed platinum- containing chemotherapies.