A Study of Advanced or Metastatic Non-small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: LY2603618; Pemetrexed
Intervention description: 150 milligram per square meter (mg/m^2) intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression; 500 mg/m^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of LY2603618 in
      combination with pemetrexed and any side effects that might be associated with it along with
      determining the effects of LY2603618 in combination with pemetrexed in participants with
      advanced or metastatic Non-small Cell Lung Cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must agree to have a tumor biopsy at screening

          -  Must have a diagnosis of advanced or metastatic non-squamous non-small cell lung
             cancer that has progressed after certain prior treatment

          -  Must be available for the duration of the study and willing to follow the study
             procedures

          -  If participant is a woman that is capable of having children, must have a negative
             pregnancy test within 7 days of taking first dose of study drug

          -  Must have discontinued radiation therapy at least 4 weeks before entering this study

        Exclusion Criteria:

          -  Must not have taken an unapproved drug as treatment for any indication within the last
             28 days before starting study treatment.

          -  Must not be pregnant or lactating, are considering becoming pregnant, or are
             considering fathering a child. Males and females with reproductive potential must
             agree to use medically approved contraceptive precautions during the trial until the
             participant's physician considers it safe to become pregnant or father a child.

          -  Must not have known positive test in human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBSAg), or hepatitis C antibodies (HCAb).

          -  Must not have previously participated in a study involving LY2603618

          -  Must not have previously taken pemetrexed for cancer

          -  Must not have a known allergy to LY2603618 or pemetrexed

          -  Must not currently have an infection that may affect participant's ability to tolerate
             the therapy

          -  Must not have a serious medical condition or disorder that would make it unsafe for
             you to participate in the study such as uncontrolled diabetes or chest pain due to
             heart disease

          -  If taking certain medications called non-steroidal anti-inflammatory drugs (NSAIDS),
             such as ibuprofen, must be able to stop taking these medications according to certain
             guidelines