First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT00981058
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Necitumumab — BIOLOGICAL
    Administered intravenously. Continues until progressive disease, toxicity, noncompliance, or withdrawal.
  • Gemcitabine — DRUG
    Administered intravenously. Continues for a maximum of six cycles.
  • Cisplatin — DRUG
    Administered intravenously. Continues for a maximum of six cycles.

Study Details

The research study is testing the investigational drug necitumumab (IMC-11F8) 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 gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.

Key Dates

Start date
Jan 7, 2010
Status verified
May 2025
Primary completion
Jun 17, 2013
Completion
May 30, 2024

Study Design

Enrollment
1,093 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Necitumumab + Gemcitabine + Cisplatin
    Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
  • Active Comparator: Gemcitabine + Cisplatin
    Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.

Primary Outcome Measure

Overall Survival Time (OS) [ Time Frame: Randomization to Death from Any Cause (Up to 31 Months) ]

Locations (15)

FacilityCityStateZIPSite coordinators
ImClone Investigational SiteChandlerArizona85224-
ImClone Investigational SiteFayettevilleArkansas72703-
ImClone Investigational SiteSacramentoCalifornia95816-
ImClone Investigational SiteGalesburgIllinois61401-
ImClone Investigational SiteGoshenIndiana46526-
ImClone Investigational SiteWichitaKansas67214-
ImClone Investigational SiteHazardKentucky41701-
ImClone Investigational SiteBaltimoreMaryland21204-
ImClone Investigational SiteJefferson CityMissouri65109-
ImClone Investigational SiteLincolnNebraska68510-
ImClone Investigational SiteNew YorkNew York10065-
ImClone Investigational SiteAkronOhio44304-
ImClone Investigational SiteCamp HillPennsylvania17011-
ImClone Investigational SiteMemphisTennessee38104-
ImClone Investigational SiteFairfaxVirginia22031-

Find similar trials in Chandler, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
ImClone Investigational Site· Chandler, AZImClone Investigational Site· Fayetteville, ARImClone Investigational Site· Sacramento, CAImClone Investigational Site· Galesburg, ILImClone Investigational Site· Goshen, INImClone Investigational Site· Wichita, KS

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