A Prospective Multi-center Phase III Randomized Controlled Trial

Phase 3

• Conditions: Carcinoma，Non-Small-Cell Lung
• Interventions: Drug: cisplatin and pemetrexed; Drug: nedaplatin+pemetrexed

• Registration Number: NCT02607592
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-18
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-25
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 293

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin and Pemetrexed	cisplatin and pemetrexed	cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
Nedaplatin and Pemetrexed	nedaplatin+pemetrexed	nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）

Primary Outcome Measures

Name	Time	Method
progression free-survival（PFS）	12months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sun Yat-sen University of cancer center; 🇨🇳 Guangzhou, Guangdong, China