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Boanmycin Hydrochloride for Injection in Combination With Docetaxel for Patients With Advanced Lung Squamous Cell Carcinoma as Salvage Chemotherapy: a Prospective, Randomized, Parallel and Controlled Clinical Trial

Phase 2
18 Years
Open (Enrolling)
Squamous Cell Lung Cancer

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Trial Information

Boanmycin Hydrochloride for Injection in Combination With Docetaxel for Patients With Advanced Lung Squamous Cell Carcinoma as Salvage Chemotherapy: a Prospective, Randomized, Parallel and Controlled Clinical Trial

At present, there is no reliable second line treatment except chemotherapy for squamous cell
carcinoma patients, the current chemotherapy regimen, including docetaxel as a single agent
which is known as the gold standard, the weekly using of docetaxel and the combination of
EGFR-TKI has few evidence for high response rates and prolonged survival.On the other hand,
the adverse reaction of chemotherapy makes the combined chemotherapy cannot improve
therapeutic effects. Boanmycin with special pharmacological basis, as well as the high
purity, may not obvious increase in adverse reactions, and probably improve the effect of
chemotherapy. At the same time, because of its low lung toxicity, especially in the combined
use of corticosteroids, and in the background of the poor survival of advanced squamous cell
lung cancer patients, the chemotherapy regimen of boanmycin plus docetaxel needs to be

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.

According to the test center, gender, disease staging (stage IIIB, IV/recurrence) and
pathologic types, patients with squamous cell lung cancer were stratified and then randomly
assigned to one of two groups. In the first group, 75 mg of docetaxel per square meter of
body-surface area, administered on day 1, followed by 5~6 mg boanmycin of per square meter
and 5mg dexamethasone on days 3,5,10 and 12, the cycle was repeated every 21days. The second
group received the reference treatment: docetaxel at a dose of 75 mg per square meter was
administered on on day 1 of a three-week cycle. The efficacy was evaluated using RESIST
standard after every 2 cycles of the treatment, the regimen will continue until the disease
progression or the appearance of not tolerable toxicity.

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

- concomitant treatment with other anticancer drugs.

- pregnancy, breast feeding or fertility but not taking contraceptive device during the

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

disease free survival

Outcome Description:

DFS was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.

Outcome Time Frame:

1.5 years

Safety Issue:


Principal Investigator

Peng Chen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

August 2014

Related Keywords:

  • Squamous Cell Lung Cancer
  • salvage chemotherapy
  • advanced squamous cell lung cancer
  • Boanmycin
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Lung Neoplasms