MedTrace Logo

Pemetrexed With or Without Carboplatin for Elderly Non-squamous Non-small Cell Lung Cancer

NCT01593293 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2012-05-08

No results posted yet for this study

Summary

The number of NSCLC patients above 70 years of age who are non-squamous histology is increasing around the world. Although previous guidelines often recommend single agent therapy for NSCLC, recent studies suggest that platinum doublets may be better than standard monotherapy in elderly. We hypothesize that for elder patients (≥70 years of age) with non-squamous NSCLC, pemetrexed and carboplatin is more effective than pemetrexed monotherapy in terms disease progression, overall survival, and quality of life and tolerability.

Conditions

Interventions

DRUG

PemCarbo

Pemetrexed 500mg/m2, Carboplatin AUC5 intravenously q 3 weeks for 4 cycles, followed by pemtrexed 500mg/m2 q 3 weeks for maintenance therapy

DRUG

Pem only

Pemetrexed 500mg/m2 intrvenously q 3 weeks till progression or unacceptable toxicity.

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Korean Cancer Study Group

    collaborator OTHER

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Sang-We Kim, M.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-11-30
Completion
2015-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593293 on ClinicalTrials.gov