A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

Sponsor
Eli Lilly and Company
Study ID
NCT01897480
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • LY2875358 — BIOLOGICAL
    Administered IV
  • Erlotinib — DRUG
    Administered Orally

Study Details

The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.

Key Dates

First listed
Jul 12, 2013
Start date
Aug 28, 2013
Status verified
Jan 2026
Primary completion
Mar 14, 2016
Completion
Jan 8, 2026

Study Design

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

Arms

  • Experimental: LY2875358 plus Erlotinib
    Lead In: Approximately 8 weeks of erlotinib 150 milligram (mg) given orally per day. Randomization: Erlotinib 150 mg given orally per day plus 750 mg LY2875358 given as 1.5 hours intravenous (IV) infusions on Days 1 and 15 of 28-day cycles.
  • Active Comparator: Erlotinib
    Lead In: Approximately 8 weeks of erlotinib 150 mg given orally per day. Randomization: Continue Erlotinib 150 mg given orally per day, in 28-day cycles.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years) ]

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