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

• ClinicalTrials.gov Identifier: NCT02088515
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Last Update Posted: March 3, 2017
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

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.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02088515
• Other Study ID Numbers: 5501068
• First Posted: March 17, 2014
• Last Update Posted: March 3, 2017
• Last Verified: April 2016

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Nedaplatin; lung squamous cell carcinoma

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Docetaxel; Nedaplatin; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action