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

Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088515
• Other study ID #: 5501068
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2014
• Last updated: March 2, 2017
• Start date: December 2013
• Est. completion date: February 2017

Study information

• Verified date: April 2016
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Drug:
• Nedaplatin

• Cisplatin

• Docetaxel

Locations

Country	Name	City	State
China	Hunan Xiangya Hospital	Changsha	Hunan
China	Nanjing Military General Hospital	Nanjing	Jiangsu
China	Shanghai Chest hospital	Shanghai	Shanghai
China	Xijing Hospital	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Adverse Events will be recorded and monitored till to normal or basal level achieved.	10 months
Primary	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	Objective Response Rate	the effectiveness will be evaluated after 2 cycles of chemotherapy is finished. 4 cycles of chemotherapy is needed for each subject.	3 months