A Prospective Multi-center Phase III Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

293 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2022-12-31

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.

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Detailed Description

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Conditions

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Carcinoma，Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nedaplatin and Pemetrexed

nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）

Group Type EXPERIMENTAL

nedaplatin+pemetrexed

Intervention Type DRUG

nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）

Cisplatin and Pemetrexed

cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）

Group Type ACTIVE_COMPARATOR

cisplatin and pemetrexed

Intervention Type DRUG

cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）

Interventions

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cisplatin and pemetrexed

cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）

Intervention Type DRUG

nedaplatin+pemetrexed

nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No