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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma，Non-Small-Cell Lung
• Intervention / Treatment: Drug: nedaplatin+pemetrexed; Drug: cisplatin and pemetrexed

• Study Type: Interventional
• Enrollment (Anticipated): 293
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: li-kun Chen, doctor; Phone Number: 13798019964; Email: chenlk@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen University of Cancer Center
      • Contact: li-kun chen, doctor; Phone Number: 13798019964

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nedaplatin and Pemetrexed; nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）	Drug: nedaplatin+pemetrexed; nedaplatin 90mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
Active Comparator: Cisplatin and Pemetrexed; cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）	Drug: cisplatin and pemetrexed; cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: li-kun Chen, Doctor, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Non-Small-Cell Lung cancer; overall toxicity value
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Cisplatin; Pemetrexed; Nedaplatin
• Other Study ID Numbers: 201507003