Nedaplatin (Jiebaishu®) Combined With Docetaxel for Advanced Lung Squamous Cell Carcinoma

Recruitment & Eligibility

Inclusion Criteria

primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
IIIB-no radiotherapy indication /IV phased by ASLC 2009 TNM criteria.
at least one measurable tumor based on RECIST ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
male or female, age≥18 or ≤75 years old
ECOG PS: 0 or 1
estimated time of survival: ≥12 weeks
suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL
suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN.
suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min
no history of chemotherapy
at the enrollment, the past operation has been over 4 weeks and the subject recovered.
for the female subject with the intact uterus, if amenorrhea is less than 24 months, pregnancy test must be negative within 28 days of enrollment. If pregnancy test has been past 7 days at the time of initial chemotherapy, urine pregnancy test must be done.
the authorized ICF must be signed

Exclusion Criteria

having the other cancer in the recent five years, cured skin basal cell carcinoma and cervical carcinoma excluded.
having the evidence of CNS metastasis, no matter if treated; if being suspicious of CNS metastasis, CNS MRI or enhanced CT scan must be done within 28 days of enrollment.
AST and /or ALT>2.5×normal ULN, and ALP>5×normal ULN.
radiotherapy in the past (excluding palliative radiotherapy for pain relief and the measurable tumor outside the radio field)
chemotherapy in the past (excluding bisphosphonates )
having the other uncontrolled diseases.
the female in pregnancy or feeding.
the subjects with the productivity capacity, but refusal to use the effective contraception measure.
participating in other clinical trial and at the time of treatment period.
allergy to the tested drugs
having the other uncontrolled diseases
BMT had been done.

Study & Design

Arm && Interventions

Group	Intervention	Description
experimental group	Nedaplatin	experimental group: Nedaplatin(（80 mg/m2, i.v Day1）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total.
experimental group	Docetaxel	experimental group: Nedaplatin(（80 mg/m2, i.v Day1）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total.
comparative group	Cisplatin	comparative group:Cisplatin (（75 mg/m2, i.v Day1 or 25 mg/m2 Day1-3）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total
comparative group	Docetaxel	comparative group:Cisplatin (（75 mg/m2, i.v Day1 or 25 mg/m2 Day1-3）in combination with Docetaxel（75 mg/m2, i.v Day1）for each cycle, 4 cycles in total

Primary Outcome Measures

Name	Time	Method
progress free survival	9 months	after being enrolled, the subjects will be subject to 4 cycles chemotherapy (each cycle: 21 days). if complete response/partial response/stable desease is confirmed, the subjects will be followed up till to the sixth months.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	3 months	the effectiveness will be evaluated after 2 cycles of chemotherapy is finished. 4 cycles of chemotherapy is needed for each subject.

Recruitment & Eligibility