First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin

Part of paid clinical trials in Nyack, New York.

Sponsor
Eli Lilly and Company
Study ID
NCT00982111
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pemetrexed — DRUG
    500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles
  • Cisplatin — DRUG
    75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
  • Necitumumab — BIOLOGICAL
    800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.

Study Details

The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.

Key Dates

Start date
Nov 2, 2009
Status verified
Dec 2021
Primary completion
Nov 14, 2012
Completion
Dec 23, 2020

Study Design

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

Arms

  • Experimental: Necitumumab + Pemetrexed + Cisplatin
    Necitumumab + Pemetrexed + Cisplatin
  • Active Comparator: Pemetrexed + Cisplatin
    Pemetrexed + Cisplatin

Primary Outcome Measure

Overall Survival Time (OS) [ Time Frame: Randomization to Death from Any Cause (Up to 31.6 Months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
ImClone Investigational SiteNyackNew York10960-

Find similar trials in Nyack, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
ImClone Investigational Site· Nyack, NY

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