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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Administered IV
Administered Orally
Herlev and Gentofte Hospital
Herlev, Capital Region, Denmark
Rigshospitalet
Copenhagen, Copenhagen, Denmark
Odense Universitetshospital
Odense C, Syd, Denmark
CHU de Caen Hopital Cote de Nacre
Caen, France
Chu Gabriel Montpied
Clermont-Ferrand, France
CHU De Grenoble Hopital Albert Michallon
Progression Free Survival (PFS)
Time frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
Change in Tumor Size (CTS)
Time frame: Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years)
Proportion of Participants Exhibiting a Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Time frame: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated 3 Years)
Duration of Response (DoR)
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years)
Time to Progressive Disease (TTPD)
Time frame: Randomization to Objective Disease Progression (Estimated 3 Years)
Proportion of Participants Exhibiting a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate [DCR])
Time frame: Baseline to Objective Disease Progression or Participant Stops Study (Estimated 3 Years)
Overall Survival (OS)
Time frame: Randomization to Death Due to Any Cause (Estimated 5 Years)
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) C30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13)
Time frame: Baseline, Objective Disease Progression or Participants Stops Study (Estimated 3 Years)
Pharmacokinetics (PK): Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) of LY2875358 and Erlotinib
Time frame: Baseline through Cycle 4 (28 Day Cycle)
Proportion of Participants with Anti-LY2875358 Antibody Response
Time frame: Baseline through 30 Day Follow Up (Estimated 3 Years)
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Grenoble, France
HCL-Hôpital Louis Pradel
Lyon (Bron) Cedex, France
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, France
CHU la Miletrie
Poitiers, France
Klinik Schillerhöhe
Gerlingen, Baden-Wurttemberg, Germany
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