Clinical trial · Interventional
A Prospective Multi-center Phase III Randomized Controlled Trial
Nedaplatin or Cisplatin Combined With Pemetrexed in the First Line Treatment of Advanced Adenocarcinoma:A Prospective Multi-center Phase III Randomized Controlled Trial
NCT02607592CI-TRIAL-00056764NACAunknownPhase 3ClinicalTrials.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 purpose of this study is to investigate the PFS, ORR, OS and overall toxicity value(OTV)on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed.
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 |
|---|---|---|---|
| Carcinoma,Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin and pemetrexed | Drug | — | UNRESOLVED |
| nedaplatin+pemetrexed | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nedaplatin and Pemetrexed
- description
- nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle)
- interventionNames
- Drug: nedaplatin+pemetrexed
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin and Pemetrexed
- description
- cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle)
- interventionNames
- Drug: cisplatin and pemetrexed
Primary outcomes (1)
- measure
- progression free-survival(PFS)
- timeFrame
- 12months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient who was confirmed primary adenocarcinoma by pathologic histology or cytology 2. The TNM staging system according to IASLC2009 was stageIV or those stageIIIB who were not fit for operation or radiotherapy 3. Including one available evaluation lesion at least according to RECIST criteria 4. Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1 .Life expectancy of at least 12 weeks.Haemoglobin ≥90g/dl, Absolute neutrophil count (ANC)≥ 2x 109/L, platelets ≥100 x 109/L. Total bilirubin ≤upper limit of normal (ULN). ALT and AST ≤ 2.5 x ULN. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula). 5. Patients who had never received any antineoplastic therapy Exclusion Criteria: 1. Patient who has another cancer in recent 5 years,not including basal cell carcinoma or cervical carcinoma in situ 2. Patient with brain metastases whose intracranial pressure symptoms can not control by using glucocorticoid or mannitol 3. Previous radiotherapy(Palliative radiotherapy in order to pain management can be excluded) 4. Patient who has used chemotherapy before(bisphosphonate can be excluded ) 5. Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease 6. Patient who is allergic to drugs we need to use 7. Patients who are in pregnancy or lactation 8. AST or ALT 》2.5 \* upper limit of normal (ULN),and ALP》5\*ULN
References
Publications (1)
- RESULTPfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available. PMID 14691125