Overview

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.

Eligibility

Inclusion Criteria:

1. Age≥18 years old.
2. Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and treatment and laboratory tests of the protocol.
3. Patient has a diagnosis of locally advanced or metastatic NSCLC as determined by histological or cytological results.
4. Patients with known EGFR-sensitive mutation /ALK fusion /ROS1 fusion must have been documented disease progression during or after targeted drugs treatments and platinum-containing chemotherapies; Patients without above positive genes must have been documented disease progression during or after PD-1/PD-L1 inhibitors treatments and platinum-containing chemotherapies (combined or sequential). Note: For prior adjuvant/neoadjuvant treatment with platinum-containing regimens of chemotherapy, progression during or within 6 months of completion of adjuvant/neoadjuvant treatment may be considered a failure of platinum-containing chemotherapy.
5. At least one measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
6. Adequate organ function.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
8. Patients of reproductive potential must be willing to use adequate contraception during the study and through 6 months after the last dose of study treatment.

Exclusion Criteria:

1. Prior use of docetaxel monotherapy or combination therapy for metastatic disease.
2. Known ≥ grade 3 hypersensitivity and/or contraindications to human albumin or docetaxel; known allergy and/or contraindications to glucocorticoids (including but not limited to active digestive tract ulcers, severe hypertension, severe hypokalemia, glaucoma, etc.).
3. Leptomeningeal metastases and/or untreated active brain metastases; if the patient's brain metastases have been treated, a stable state is required prior to randomization (no radiographically confirmed progression and normal return of all neurologically relevant symptoms within 4 weeks prior to randomization), no new brain metastases or enlargement of the original brain metastases are shown on radiographs, and steroid hormone therapy is not required for at least 7 days prior to randomization.
4. History of other malignancies within 3 years prior to randomization, excluding basal cell or squamous cell carcinoma of skin and cervical carcinoma in situ that have been radically treated.
5. Serosal effusion requiring drainage or diuretic treatment (such as pleural effusion, peritoneal effusion, or pericardial effusion) within 2 weeks before randomization.
6. History of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:

        （1) Uncontrolled hypertension (defined as persistent systolic blood pressure ≥ 160 mmHg
        and/or diastolic blood pressure ≥ 100 mmHg despite the use of antihypertensive
        medications); （2) Severe arrhythmias and conduction abnormalities requiring treatment with
        antiarrhythmic agents other than beta-blockers or digoxin (except atrial fibrillation and
        paroxysmal supraventricular tachycardia); （3) History of myocardial infarction, unstable
        angina pectoris, angioplasty, and coronary artery bridging surgery; （4) Heart failure, New
        York Heart Association (NYHA)≥grade 3; （5) QTcF > 480 ms; （6) Other heart diseases that
        investigators identify as clinically significant. 7. Active infection treated with
        intravenous antibiotics within 2 weeks prior to randomization.
        8. Patients who have undergone major organ surgery (excluding needle biopsy) within 4 weeks
        prior to randomization or who will require elective surgery during the trial period.
        9. The toxicity of previous anti-tumor therapy does not return to grade≤1 (CTCAE v5.0),
        except for grade 2 neuropathy, alopecia, hypothyroidism caused by prior anti-tumor therapy
        (including hormone replacement therapy), and toxicity judged by the investigator to be of
        no safety risk.
        10. Receiving antitumor therapy such as chemotherapy, targeted therapy, immunotherapy, and
        other investigational agents within 4 weeks or 5 half-lives (whichever is shorter but at
        least 2 weeks) prior to randomization, other conditions as follows: Received radiotherapy
        within 2 weeks prior to randomization, or received radiotherapy prior to 2 weeks of
        randomization but patient has not recovered from all acute toxicity and requires hormone
        therapy; Chinese medicines with anti-tumor indications administered within 2 weeks prior to
        randomization.
        11. Use of potent inhibitors or potent inducers of CYP3A4 within 2 weeks prior to
        randomization.
        12. Life expectancy < 3 months. 13. HBsAg/HBcAb positive with HBV-DNA ≥ 10^2 cps/mL or ≥
        2000 IU/mL); hepatitis C antibody-positive with a positive PCR result for HCV RNA; Patients
        infected with human immunodeficiency virus (HIV); Patients with active tuberculosis.
        14. Patients are not suitable for the study in the investigator's opinion, include but are
        not limited to, conditions in which the patient has a serious or uncontrolled medical
        condition, interferes with the interpretation of the study results, and interferes with
        compliance with the trial.