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

Primary Purpose

Squamous Cell Carcinoma

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nedaplatin
Cisplatin
Docetaxel
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring Nedaplatin, lung squamous cell carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hunan Xiangya Hospital
  • Nanjing Military General Hospital
  • Shanghai Chest hospital
  • Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

comparative group

Arm Description

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 (（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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2014
Last Updated
March 2, 2017
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02088515
Brief Title
Nedaplatin (Jiebaishu®) Combined With Docetaxel for Advanced Lung Squamous Cell Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
Keywords
Nedaplatin, lung squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
comparative group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nedaplatin
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Primary Outcome Measure Information:
Title
progress free survival
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
the effectiveness will be evaluated after 2 cycles of chemotherapy is finished. 4 cycles of chemotherapy is needed for each subject.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Adverse Events will be recorded and monitored till to normal or basal level achieved.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hunan Xiangya Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Nanjing Military General Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Shanghai Chest hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Xijing Hospital
City
Xian
State/Province
Shanxi
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30017831
Citation
Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, Zhao Q, Fan Y, Wu G, Ma Z, Fang J, Yu Q, Liu Z. Nedaplatin Plus Docetaxel Versus Cisplatin Plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung - A Multicenter, Open-label, Randomized, Phase III Trial. J Thorac Oncol. 2018 Nov;13(11):1743-1749. doi: 10.1016/j.jtho.2018.07.006. Epub 2018 Jul 11.
Results Reference
derived

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

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