A Prospective Multi-center Phase III Randomized Controlled Trial (NACA)

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Carcinoma，Non-Small-Cell Lung

Treatments: Drug: nedaplatin+pemetrexed; Drug: cisplatin and pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT02607592

201507003

Details and patient eligibility

About

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.

Enrollment: 293 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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293 participants in 2 patient groups

Nedaplatin and Pemetrexed

Experimental group

Description:

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

Treatment:

Drug: nedaplatin+pemetrexed

Cisplatin and Pemetrexed

Active Comparator group

Description:

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

Treatment:

Drug: cisplatin and pemetrexed