A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Edina, Minnesota.

Sponsor
Eli Lilly and Company
Study ID
NCT02941601
Phase
PHASE2
Status
Withdrawn

Conditions

  • Locally Advanced Squamous Non-Small Cell Lung Cancer
  • Metastatic Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Necitumumab — DRUG
    Administered IV
  • Gemcitabine — DRUG
    Administered IV
  • Carboplatin — DRUG
    Administered IV

Study Details

The main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.

Key Dates

Start date
Nov 30, 2016
Status verified
Sep 2019
Primary completion
Dec 31, 2017
Completion
Feb 28, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Necitumumab + Gemcitabine and Carboplatin
    Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
  • Experimental: Cohort 2: Necitumumab + Gemcitabine and Carboplatin
    Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Primary Outcome Measure

Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 18 Months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fairview Southdale Oncology ClinicEdinaMinnesota55435-

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By research site
Fairview Southdale Oncology Clinic· Edina, MN