Clinical Trial of Boanmycin Hydrochloride With Docetaxel for Patients With Lung Squamous Cell Cancer as Chemotherapy

This predictive, randomized, double-blind, multi-center trial is going to evaluate the efficacy and safety of two regimens of boanmycin plus docetaxel versus docetaxel alone as a second line treatment for chemotherapy for stage IIIb-IV or postoperative recurrent squamous cell lung cancer patients.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* histologically or cytology confirmed III，IV or after operation recurrent squamous cell lung cancer;
* disease progressed after first-line chemotherapy and not suitable for EGFR-TKI;
* no radiotherapy for metastases outside the lung 4 weeks before;
* the lesions are measurable in CT images and are measured follow criteria RECIST 1.1 2 weeks before randomization;
* ECOG scale 0-1, expected survival\>3 month;
* white blood count ≥ 3,500/mm3, absolute neutrophil≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count≥ 90 g/dL；serum bilirubin level ≤ 1.5 of the upper limit of normal(ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase≤ 2.5 ULN, serum creatinine≤ 1.5 ULN;
* with good compliance；

Exclusion Criteria:

* past history of major operation in 4 weeks;
* involved in other clinical trials in 4 weeks;
* past history of central nervous system or relevant disease except for well-controlled CNS metastasis;
* past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
* concomitant treatment with other anticancer drugs.
* pregnancy, breast feeding or fertility but not taking contraceptive device during the trials;
* radiotherapy for target lesions in lung;
* clear TKI-related mutation in EGFR;
* with severe heart disease, hypertension, diabetes mellitus or active infection.
* past history of allergy to taxanes;
* past history of severe acute or chronic kidney disease;
* active hepatitis b or HIV positive patients;
* cannot tolerate Corticosteroid;
* past history of COPD or other critical basic pulmonary diseases;
* history of severe mental illness.

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