a study of ly2510924 in participants with extensive-stage small cell lung carcinoma

Conditions: Extensive Stage Small Cell Lung Carcinoma

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

Keywords: cancer lung metastasis