A Prospective Multi-center Phase III Randomized Controlled Trial

NCT02607592 | Unknown Phase 3 DMC

• 1 other identifier: 201507003
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma，Non-Small-Cell Lung

Keywords

Non-Small-Cell Lung cancer; overall toxicity value

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• objective response rate （ORR）

  12months

• overall survival（OS）

  24 months

• overall toxicity value

  12 months

• Progression-Free Survival (PFS) rate at 18 weeks

  20 weeks

Study Arms (2)

Nedaplatin and Pemetrexed

EXPERIMENTAL

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

Drug: nedaplatin+pemetrexed

Cisplatin and Pemetrexed

ACTIVE COMPARATOR

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

Drug: cisplatin and pemetrexed

Interventions

cisplatin and pemetrexed DRUG

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

Cisplatin and Pemetrexed

nedaplatin+pemetrexed DRUG

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

Nedaplatin and Pemetrexed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University of cancer center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related 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 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.

  PMID: 14691125 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• li-kun Chen, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

li-kun chen, Doctor

CONTACT

13798019964; chenlk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 18, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

CN (1)