A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma
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)
Checked against the public recordLast updated Jul 23, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: LY2510924; Drug: Carboplatin; Drug: Etoposide
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Denver, Colorado
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Fort Myers, Florida
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Orlando, Florida
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Pensacola, Florida
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Chicago, Illinois
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bethesda, Maryland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Springfield, Missouri
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Omaha, Nebraska
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Cincinnati, Ohio
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenville, South Carolina
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Chattanooga, Tennessee
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Memphis, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 23, 2019. Always confirm current availability with the study team.