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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
disease free survival
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.
Peng Chen, M.D.
Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital
China: Food and Drug Administration