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

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC - Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) - Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q) - Eastern Cooperative Oncology Group (ECOG) performance status of = 2 - Haven't received any prior systemic chemotherapy for Stage IV NSCLC (unless received as neoadjuvant or adjuvant therapy for early-stage NSCLC disease and completed therapy at least 6 months prior to enrollment) - Availability of adequate tumor material (block or slides) Exclusion Criteria: - Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device - Have previously completed or withdrawn from this study or any other study investigating LY2875358 - Have a serious concomitant systemic disorder or significant cardiac disease - Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently - Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study - Have major surgery less than 2 weeks prior to the initiation of study treatment therapy - Pregnant or lactating women

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)

Secondary Outcome Measures

Name	Time	Method
Change in Tumor Size (CTS);Proportion of Participants Exhibiting a Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]);Duration of Response (DoR);Time to Progressive Disease (TTPD);Proportion of Participants Exhibiting a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate [DCR]);Overall Survival (OS);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);Pharmacokinetics (PK): Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) of LY2875358 and Erlotinib;Proportion of Participants with Anti-LY2875358 Antibody Response

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

Recruitment & Eligibility

Study & Design

Related Trials

A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.

A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.

A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.

A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.

A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.

A Randomized, Controlled Phase 2 Study Evaluating LY2875358 plus Erlotinib versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Activating EGFR Mutations Who Have Disease Control after an 8-Week Lead-In Treatment with Erlotinib

A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.

A study, in which patients with late stage lung cancer and changes in a gene called EGFR, will be first treated for 8 weeks with the drug erlotinib and if they have clinical benfit will receive either a combination of an experimental drug called LY2875358 plus erlotinib or erlotinib alone.

A prospective randomized phase II study evaluating the monitoring of imatinib mesylate (Gliveec®) plasmatic through level in patients newly diagnosed with chronic phase chronic myelogenous leukaemia (CP-CML). - OPTIM IMATINIB

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