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

Primary Purpose

Carcinoma，Non-Small-Cell Lung

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

cisplatin and pemetrexed

nedaplatin+pemetrexed

About this trial

This is an interventional treatment trial for Carcinoma，Non-Small-Cell Lung focused on measuring Non-Small-Cell Lung cancer, overall toxicity value

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sun Yat-sen University of cancer centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nedaplatin and Pemetrexed

Cisplatin and Pemetrexed

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

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

overall toxicity value

toxicity graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0

Progression-Free Survival (PFS) rate at 18 weeks

the proportion (%) of patients without disease progression at 18 weeks

Full Information

NCT ID

NCT02607592

First Posted

November 16, 2015

Last Updated

February 8, 2022

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02607592

Brief Title

A Prospective Multi-center Phase III Randomized Controlled Trial

Acronym

NACA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 2015 (undefined)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma，Non-Small-Cell Lung

Keywords

Non-Small-Cell Lung cancer, overall toxicity value

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

293 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nedaplatin and Pemetrexed

Arm Type

Experimental

Arm Description

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

Arm Title

Cisplatin and Pemetrexed

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

cisplatin and pemetrexed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

nedaplatin+pemetrexed

Intervention Description

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

Primary Outcome Measure Information:

Title

progression free-survival（PFS）

Description

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

Time Frame

12months

Secondary Outcome Measure Information:

Title

objective response rate （ORR）

Description

ORR is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).

Time Frame

12months

Title

overall survival（OS）

Description

OS is defined as the time from the starting date of study drug to the date of death due to any cause

Time Frame

24 months

Title

overall toxicity value

Description

toxicity graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0

Time Frame

12 months

Title

Progression-Free Survival (PFS) rate at 18 weeks

Description

the proportion (%) of patients without disease progression at 18 weeks

Time Frame

20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

li-kun chen, Doctor

Phone

13798019964

chenlk@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

li-kun Chen, Doctor

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University of cancer center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

li-kun chen, doctor

Phone

13798019964

12. IPD Sharing Statement

Citations:

PubMed Identifier

14691125

Citation

Pfister 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.

Results Reference

result

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A Prospective Multi-center Phase III Randomized Controlled Trial

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