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A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer

NCT00789373 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 939

Last updated 2018-12-14

Study results available
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Summary

This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo.

Conditions

Interventions

DRUG

Pemetrexed

Induction therapy: 500 mg/m\^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles

DRUG

Cisplatin

Induction therapy: Cisplatin: 75 mg/m\^2, IV, on Day 1 of each 21-day cycle for 4 cycles

DRUG

Placebo

Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation

DRUG

Pemetrexed

Maintenance therapy: 500 mg/m\^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.

OTHER

Best Supportive Care

Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-06-30
Completion
2017-11-30

Countries

  • Australia
  • Belgium
  • Finland
  • France
  • Germany
  • Greece
  • India
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00789373 on ClinicalTrials.gov