Clinical trial · Interventional
Nedaplatin (Jiebaishu®) Combined With Docetaxel for Advanced Lung Squamous Cell Carcinoma
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
NCT02088515CI-TRIAL-00026228completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Nedaplatin | Drug | Nedaplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: Nedaplatin
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- comparative 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
- interventionNames
- Drug: Cisplatin
- Drug: Docetaxel
Primary outcomes (1)
- measure
- progress free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLu 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