A Prospective Multi-center Phase III Randomized Controlled Trial

Carcinoma,Non-Small-Cell Lung Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02607592
• Other study ID #: 201507003
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Sun Yat-sen University
• Contact: li-kun chen, Doctor
• Phone: 13798019964
• Email: chenlk[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 293
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Carcinoma,Non-Small-Cell Lung

Intervention

Drug:
• cisplatin and pemetrexed
cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle)
• nedaplatin+pemetrexed
nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 (Every three weeks for a treatment cycle)

Locations

Country	Name	City	State
China	Sun Yat-sen University of cancer center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 gui — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	overall toxicity value	toxicity graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0	12 months
Secondary	Progression-Free Survival (PFS) rate at 18 weeks	the proportion (%) of patients without disease progression at 18 weeks	20 weeks