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Withdrawn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

First listed
Oct 21, 2016
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