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

Study Overview
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Brief Summary
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The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin is a second-generation platinum compound that is more active against squamous cell carcinoma of the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.

Official Title
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Nedaplatin (Jiebaishu®) and Docetaxel in Comparison With Cisplatin and Docetaxel Regimen for the First Line Treatment of Advanced Squamous Cell Carcinoma of Lung(IIIB/IV): Randomized, Controlled, Multicentre Study

Conditions
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Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Nedaplatin
* Drug: Cisplatin
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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. | Drug: Nedaplatin<br> <br> Drug: Docetaxel<br> <br> |
| Active Comparator: comparative group<br>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 | Drug: Cisplatin<br> <br> Drug: Docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress free survival | 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. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | the effectiveness will be evaluated after 2 cycles of chemotherapy is finished. 4 cycles of chemotherapy is needed for each subject. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nedaplatin, lung squamous cell carcinoma