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A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

NCT00606021 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2011-12-26

Study results available
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Summary

This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.

A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

pemetrexed

500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

DRUG

Best Supportive Care

Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am to 5pm Eastern Time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Egypt
  • Lebanon
  • Saudi Arabia

Study Locations

More Related Trials

Entities

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 NCT00606021 on ClinicalTrials.gov