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Squamous Cell CarcinomaPhase 4NCT02088515

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

A Phase 4 study testing Nedaplatin, Cisplatin and Docetaxel in people with Squamous Cell Carcinoma, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Squamous Cell Carcinoma
What is being tested?
Nedaplatin, Cisplatin and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
4 sitesChina
Study dates
Dec 2013to Feb 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Hunan Xiangya Hospital

    Changsha, Hunan

  • Nanjing Military General Hospital

    Nanjing, Jiangsu

  • Shanghai Chest hospital

    Shanghai, Shanghai Municipality, 200000

  • Xijing Hospital

    Xian, Shanxi

Other trials in China

About this study

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

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.

Being tested
Nedaplatin, Cisplatin, Docetaxel
Keywords
Nedaplatin, lung squamous cell carcinoma
Medical subject headings
Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02088515
Study groupRoleWhat they receive
experimental groupExperimentalexperimental 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.
Receives: Drug: Nedaplatin; Drug: Docetaxel
comparative groupActive comparatorcomparative 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
Receives: Drug: Cisplatin; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 months

Secondary outcomes (1)

  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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionOct 2016
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02088515
Sponsor's protocol ID
5501068
Status last verified
Apr 2016
First submitted
6 Mar 2014
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nedaplatin, Cisplatin and Docetaxel in people with Squamous Cell Carcinoma, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progress free survival (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02088515, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.

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