A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers

Non-small Cell Lung Cancer Clinical Trial

Official title:

Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01860508
• Other study ID #: 2013-PEM-WJL
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2013
• Last updated: July 4, 2013
• Start date: February 2013

Study information

• Verified date: July 2013
• Source: Fudan University
• Contact: Jia lei Wang, Master
• Phone: 02164175590
• Email: luwangjialei[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

PFS

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

.=65 years or PS 2

• Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer

• Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD

• Presence of at least one index lesion measurable by CT scan or MRI

• leucocyte = 3.5×109/L

• neutrophil = 1.5×109/L

• platelet = 80×109/L

• Hemoglobin = 9g/L

• ALT and AST = 2.5×ULN ,Tbil= 1.5×ULN

• BUN= 1.5×ULN

• Signed written informed consent

Exclusion Criteria:

• squamous carcinoma or small cell lung cancer

• Patients were allergic to pemetrexed

• Patients received chemotherapy before

• Uncontrolled acute infection

.Uncontrolled pleural effusion

• Severe symptomatic heart disease

• Severe infection or metabolic disfunction

• Patients with other malignant tumor

• Uncontrolled brain metastases

• Patients have accepted other clinical trials

• Female patients during their pregnant and lactation period, or patients without contraception

• Mental disorientation of disorder

• Glucocorticoids taboo

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• pemetrexed /carboplatin

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		from the first cycle of treatment (day one) to two month after the last cycle	No