a study of ly2940680 in small cell lung cancer

Conditions: Small Cell Lung Carcinoma

Summary: the purpose of this study is to find a recommended dose of ly2940680 that can be safely given in combination with etoposide and carboplatin followed by ly2940680 alone in participants with extensive-disease small cell lung cancer. the study will also compare progression-free survival in participants who are administered etoposide, carboplatin and ly2940680 followed by ly2940680 alone versus etoposide, carboplatin, and placebo followed by placebo alone.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of small cell lung cancer (sclc), including malignant pleural effusion that is extensive stage per the international staging system * performance status of 0 to 1 on the eastern cooperative oncology group (ecog) performance status schedule * no prior systemic chemotherapy, immunotherapy, or biological therapy for sclc * prior radiation therapy allowed to \<25% of the bone marrow. participants who have received prior radiation to the whole pelvis or chest for the treatment of sclc are not eligible * at least 1 unidimensionally measurable lesion meeting response evaluation criteria in solid tumors (recist) version 1.1 * adequate organ function including the following: * adequate bone marrow reserve: absolute neutrophil count (anc) ≥1.5 x 10\^9/ liter (l), platelets ≥100 x 10\^9/l, and hemoglobin ≥9 grams/deciliter (g/dl) * hepatic: bilirubin ≤1.5 times the upper limit of normal (uln), alkaline phosphatase (ap), serum alanine aminotransferase (alt) and aspartate transaminase (ast) ≤3.0 x uln (ap, ast, and alt ≤5 x uln is acceptable if liver has tumor involvement) * renal: calculated creatinine clearance (crcl) ≥50 milliliters per minute (ml/min) based on the standard cockcroft and gault formula * estimated life expectancy of at least 12 weeks * for women: must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment. for men: must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period * availability of a tumor tissue sample * able to swallow capsules 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 * have previously participated in a study involving ly2940680 * have previously received treatment with carboplatin or etoposide * have a mixed histological diagnosis of sclc and non-small cell lung cancer (nsclc) * have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol * have an active infection \[≥38.5 degrees celsius and/or receiving intravenous (iv) antibiotic therapy\] * have a serious cardiac condition * have had a prior malignancy other than sclc, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. participants with a history of non-metastatic prostate cancer, including biochemical relapse only, will be eligible even if diagnosed less than 5 years previously * symptomatic central nervous system (cns) metastases and asymptomatic cns metastases requiring concurrent corticosteroid therapy. treated stable cns metastases are allowed; the participant must be stable after radiotherapy for ≥2 weeks and off of corticosteroids for ≥1 week * presence of clinically significant third-space fluid collections that cannot be controlled prior to study entry * significant weight loss (that is, ≥10%) over the 6-week period prior to study entry * concurrent administration of any other antitumor therapy. an exception will be made for non-metastatic prostate cancer participants continuing androgen blockade therapy only or breast cancer participants continuing adjuvant antiestrogen therapy only (for example, an aromatase inhibitor) * females who are breastfeeding * have corrected qt interval (qtc) of \>470 millisecond (msec) on screening electrocardiogram (ecg) * have received medications that are strong inhibitors of cytochrome p450 3a4 (cyp3a4) within 7 days prior to receiving study drug