A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma
Condition: Extensive Stage Small Cell Lung Carcinoma
MeSH terms: Carcinoma; Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: LY2510924; Carboplatin; Etoposide
Intervention description: Administered subcutaneous injection; Administered intravenously; Administered intravenously
Intervention MeSH terms: Carboplatin; Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Lung; Metastasis

Summary:

      The purpose of this trial is to compare the progression free survival of LY2510924 +
      carboplatin + etoposide therapy versus carboplatin + etoposide therapy in participants with
      extensive-stage disease small cell lung cancer (SCLC)
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically or cytologically confirmed extensive-stage disease small cell lung
             carcinoma

          -  measurable disease as defined by the New Response Evaluation Criteria in Solid Tumors
             (RECIST): Revised RECIST Guideline (version 1.1)

          -  no prior systemic chemotherapy, immunotherapy, biological, hormonal, or
             investigational therapy for SCLC

          -  a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale

          -  adequate organ function, including:

               -  hematologic: absolute neutrophil (segmented and bands) count (ANC) greater than
                  or equal to (≥)1.5 x 10^9/ liter (L), platelets ≥100 x 10^9/L, and hemoglobin ≥9
                  grams per deciliter (g/dL).

               -  hepatic: bilirubin less than or equal to (≤)1.5 times upper limits of normal
                  (ULN), and alkaline phosphatase (AP), alanine aminotransferase (ALT) and
                  aspartate aminotransferase (AST) ≤3.0 times ULN (AP, AST, and ALT ≤5 times ULN is
                  acceptable if liver has tumor involvement

               -  renal: calculated creatinine clearance (CrCl) ≥45 milliliters per minute (mL/min)
                  based on the standard Cockcroft and Gault formula

          -  For women: Must be surgically sterile (surgical procedure: bilateral tubal ligation),
             post-menopausal (at least 12 consecutive months of amenorrhea), or compliant with a
             medically approved contraceptive regimen (intrauterine device [IUD], birth control
             pills, or barrier device) during and for 6 months after the treatment period; must
             have a negative serum or urine pregnancy test within 7 days before study enrollment,
             and must not be breast-feeding. For men: Must be surgically sterile or compliant with
             a contraceptive regimen during and for 6 months after the treatment period.

          -  estimated life expectancy of at least 12 weeks

          -  written informed consent prior to any study-specific procedures

          -  able and willing to learn to self-administer LY2510924, or have a caregiver who is
             willing to learn and able to administer LY2510924 by subcutaneous (SC) injection

        Exclusion Criteria:

          -  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, or
             concurrently enrolled in any other type of medical research judged not to be
             scientifically or medically compatible with this study

          -  prior treatment with carboplatin/etoposide or LY2510924

          -  any concurrent administration of any other antitumor therapy

          -  diagnosis of non-small cell lung cancer (NSCLC) or mixed NSCLC and small cell lung
             cancer (SCLC)

          -  no prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma
             skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or
             more years prior to study entry with no subsequent evidence of recurrence.
             Participants with a history of low grade (Gleason score ≤6) localized prostate cancer
             will be eligible even if diagnosed less than 5 years prior to study entry

          -  serious concomitant systemic disorder that, in the opinion of the investigator, would
             compromise the participant's ability to adhere to the study requirements

          -  active or ongoing infection during screening requiring the use of systemic antibiotics

          -  serious cardiac condition, such as myocardial infarction within 6 months, angina, or
             heart disease as defined by the New York Heart Association Class III or IV

          -  clinical evidence of central nervous system (CNS) metastases or leptomeningeal
             carcinomatosis, except for individuals who have previously- treated central nervous
             system (CNS) metastases, are asymptomatic, and have had no requirement for steroid
             medication for 1 week prior to the first dose of study drug and have completed
             radiation 2 weeks prior to the first dose of study drug.

          -  known or suspected allergy to any agent given in association with this trial

          -  pregnant or lactating women