A Study for Participants With Small-Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: LY2523355; Granulocyte colony-stimulating factor (G-CSF)
Intervention description: Administered intravenously as a 1-hour infusion; Administered subcutaneously
Intervention MeSH terms: Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Part A: This study evaluates an experimental treatment in participants with extensive-disease
      in small-cell lung cancer.

      Part B: This study evaluates an experimental treatment in participants with extensive-disease
      in small-cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of extensive-disease small-cell lung cancer

          -  Have the presence of measurable disease as defined by the Response Evaluation Criteria
             in Solid Tumors (RECIST 1.1)

          -  Have received at least 1 prior chemotherapy regimen with agents known to provide
             clinical benefit for small-cell lung cancer and be, in the opinion of the
             investigator, an appropriate candidate for experimental therapy

          -  Have discontinued all previous therapies for cancer, including chemotherapy, biologic
             therapy, hormone therapy, or radiotherapy. Participants must have recovered from the
             acute effects of therapy (except alopecia and fatigue) before study enrollment

          -  Part A: Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group
             scale

          -  Part B: Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group
             scale

        Exclusion Criteria:

          -  Have received treatment within 28 days of the first dose of LY2523355 with a drug that
             has not received regulatory approval for any indication

          -  Have a mixed histological diagnosis of small-cell lung cancer and non-small-cell lung
             cancer

          -  Have serious preexisting medical conditions that, in the opinion of the investigator,
             would preclude participation in this study

          -  Part A: Have symptomatic, untreated, or uncontrolled central nervous system (CNS)
             metastases. Participants with treated CNS metastases are eligible provided their
             disease is radiographically stable, asymptomatic, and corticosteroid use has been
             discontinued for at least 2 weeks prior to the first dose of study drug. Screening of
             asymptomatic participants without history of CNS metastases is not required

          -  Part B: Have symptomatic, untreated, or uncontrolled CNS metastases or a history of
             CNS metastases. Participants who have received prophylactic radiation are not
             excluded. Screening of asymptomatic participants without history of CNS metastases is
             not required