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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02088515
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Drug: Nedaplatin Drug: Cisplatin Drug: Docetaxel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: experimental group
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
Drug: Docetaxel
Active Comparator: comparative group
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
Drug: Docetaxel

Primary Outcome Measures :
  1. progress free survival [ Time Frame: 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 :
  1. Objective Response Rate [ Time Frame: 3 months ]
    the effectiveness will be evaluated after 2 cycles of chemotherapy is finished. 4 cycles of chemotherapy is needed for each subject.

Other Outcome Measures:
  1. Adverse Events [ Time Frame: 10 months ]
    Adverse Events will be recorded and monitored till to normal or basal level achieved.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. having the other cancer in the recent five years, cured skin basal cell carcinoma and cervical carcinoma excluded.
  2. 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.
  3. AST and /or ALT>2.5×normal ULN, and ALP>5×normal ULN.
  4. radiotherapy in the past (excluding palliative radiotherapy for pain relief and the measurable tumor outside the radio field)
  5. chemotherapy in the past (excluding bisphosphonates )
  6. having the other uncontrolled diseases.
  7. the female in pregnancy or feeding.
  8. the subjects with the productivity capacity, but refusal to use the effective contraception measure.
  9. participating in other clinical trial and at the time of treatment period.
  10. allergy to the tested drugs
  11. having the other uncontrolled diseases
  12. BMT had been done.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02088515

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China, Hunan
Hunan Xiangya Hospital
Changsha, Hunan, China
China, Jiangsu
Nanjing Military General Hospital
Nanjing, Jiangsu, China
China, Shanghai
Shanghai Chest hospital
Shanghai, Shanghai, China, 200000
China, Shanxi
Xijing Hospital
Xian, Shanxi, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd. Identifier: NCT02088515    
Other Study ID Numbers: 5501068
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: April 2016
Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
lung squamous cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action