A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer

Sponsor
Eli Lilly and Company
Study ID
NCT00550173
Phase
PHASE2
Status
Completed

Conditions

  • Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pemetrexed — DRUG
    500 milligrams per meter squared (mg/m\^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops
  • erlotinib — DRUG
    150 mg, orally, once daily until progression or unacceptable toxicity develops

Study Details

The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.

Key Dates

First listed
Oct 29, 2007
Start date
Nov 30, 2007
Status verified
Jan 2013
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
247 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pemetrexed + Erlotinib
    Pemetrexed 500 milligrams per meter squared (mg/m\^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
  • Active Comparator: Erlotinib
    Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
  • Active Comparator: Pemetrexed
    Pemetrexed 500 mg/m\^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Randomization to measured PD up to 38 months ]

Related Studies