A Prospective Multi-center Phase III Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Nedaplatin or Cisplatin Combined With Pemetrexed in the First Line Treatment of Advanced Adenocarcinoma：A Prospective Multi-center Phase III Randomized Controlled Trial

Conditions
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Carcinoma，Non-Small-Cell Lung

Intervention / Treatment
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* Drug: cisplatin and pemetrexed
* Drug: nedaplatin+pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who was confirmed primary adenocarcinoma by pathologic histology or cytology The TNM staging system according to IASLC2009 was stageIV or those stageIIIB who were not fit for operation or radiotherapy Including one available evaluation lesion at least according to RECIST criteria 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). Patients who had never received any antineoplastic therapy Exclusion Criteria: Patient who has another cancer in recent 5 years,not including basal cell carcinoma or cervical carcinoma in situ Patient with brain metastases whose intracranial pressure symptoms can not control by using glucocorticoid or mannitol Previous radiotherapy（Palliative radiotherapy in order to pain management can be excluded） Patient who has used chemotherapy before(bisphosphonate can be excluded ) 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 Patient who is allergic to drugs we need to use Patients who are in pregnancy or lactation AST or ALT 》2.5 * upper limit of normal (ULN)，and ALP》5*ULN

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nedaplatin and Pemetrexed<br>nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle） | Drug: nedaplatin+pemetrexed<br>* nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）<br>|
| Active Comparator: Cisplatin and Pemetrexed<br>cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle） | Drug: cisplatin and pemetrexed<br>* cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free-survival（PFS） | Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate （ORR） | ORR is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR). | 12months | 
| overall survival（OS） | OS is defined as the time from the starting date of study drug to the date of death due to any cause | 24 months | 
| overall toxicity value | toxicity graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 | 12 months | 
| Progression-Free Survival (PFS) rate at 18 weeks | the proportion (%) of patients without disease progression at 18 weeks | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small-Cell Lung cancer, overall toxicity value