A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT02451930
Phase
PHASE1
Status
Completed

Conditions

  • Stage IV Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Necitumumab — DRUG
    Administered IV
  • Pembrolizumab — DRUG
    Administered IV

Study Details

The main purpose of this study is to evaluate the safety and efficacy of the combination of necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer (NSCLC).

Key Dates

Start date
Sep 4, 2015
Status verified
Oct 2019
Primary completion
Jan 26, 2017
Completion
Sep 17, 2019

Study Design

Enrollment
71 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Necitumumab + Pembrolizumab
    Part A Cohort 1: 600 mg Necitumumab + 200 mg Pembrolizumab: Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 600 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC (all histologies). Part A Cohort 2, Part B and Part C: 800mg Necitumumab + 200mg Pembrolizumab: Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in Part A cohort 2 participants with any histology, Part B and C participants with Stage IV NSCLC of squamous and nonsquamous histology. Part C were Japan participants. Part C were Japan participants.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) in Part A and Part C [ Time Frame: Baseline through Cycle 1 (21 day cycles) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33916-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
Tennessee Oncology PLLCNashvilleTennessee37203-

Find similar trials in Fort Myers, FL

By research site
Florida Cancer Specialists· Fort Myers, FLFlorida Cancer Specialists· St. Petersburg, FLTennessee Oncology PLLC· Nashville, TN

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