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

NCT02088515 | Completed Phase 4

• 1 other identifier: 5501068
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 4

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.

Conditions

Squamous Cell Carcinoma

Keywords

Nedaplatin; lung squamous cell carcinoma

Outcome Measures

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.

  9 months

Secondary Outcomes (1)

• Objective Response Rate

  3 months

Other Outcomes (1)

• Adverse Events

  10 months

Study Arms (2)

experimental group

EXPERIMENTAL

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

comparative group

ACTIVE COMPARATOR

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

Nedaplatin DRUG

experimental group

Cisplatin DRUG

comparative group

Docetaxel DRUG

comparative group; experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (4)

Hunan Xiangya Hospital

Changsha, Hunan, China

Location

Nanjing Military General Hospital

Nanjing, Jiangsu, China

Location

Shanghai Chest hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Xijing Hospital

Xian, Shanxi, China

Location

Related Publications (1)

• 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.

  PMID: 30017831 DERIVED

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

nedaplatin; Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 17, 2014
• Study Start: December 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: February 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2016-04

Locations

CN (4)