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CompletedNCT02088515Updated Mar 3, 2017

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

A Phase 4 interventional study of Nedaplatin and Cisplatin in Squamous Cell Carcinoma, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Completed at 4 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-03.

Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2013, registered Mar 2014).
Phase
Phase 4
Study type
Interventional
Enrollment
290
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Squamous Cell Carcinoma

Keywords

  • Nedaplatin
  • lung squamous cell carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 290 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 75 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
290 participants (actual)

Study arms

  • 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

Interventions

  • DrugNedaplatin
  • DrugCisplatin
  • DrugDocetaxel
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 months

Secondary outcomes

  1. Objective Response Rate

    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 outcomes

  1. Adverse Events

    Adverse Events will be recorded and monitored till to normal or basal level achieved.

    Time frame: 10 months

07

Study locations

4 sites
  • Hunan Xiangya Hospital
    Changsha, Hunan, China
  • Nanjing Military General Hospital
    Nanjing, Jiangsu, China
  • Shanghai Chest hospital
    Shanghai, Shanghai 200000, China
  • Xijing Hospital
    Xian, Shanxi, China
08

References and documents

Publications

  • 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. PubMed 30017831 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02088515
Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 17, 2014
Start date
Dec 2013
Primary completion
Oct 2016
Completion
Feb 2017
Last update
Mar 3, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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