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

Simcere

Status and phase: Completed; Phase 4

Conditions: Squamous Cell Carcinoma

Treatments: Drug: Nedaplatin; Drug: Docetaxel; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02088515

5501068

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

experimental group

Experimental group

Description:

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.

Treatment:

Drug: Nedaplatin

Drug: Docetaxel

comparative group

Active Comparator group

Description:

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

Treatment:

Drug: Docetaxel

Drug: Cisplatin