Overview

This trial is active, not recruiting.

Condition extensive stage small cell lung carcinoma
Treatments ly2510924, carboplatin, etoposide
Phase phase 2
Sponsor Eli Lilly and Company
Start date September 2011
End date January 2014
Trial size 90 participants
Trial identifier NCT01439568, 14242, I2V-MC-CXAC

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
LY2510924: 20 milligram (mg) administered once daily as a subcutaneous injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
ly2510924
Administered subcutaneous injection
carboplatin
Administered intravenously
etoposide
Administered intravenously
(Active Comparator)
Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
carboplatin
Administered intravenously
etoposide
Administered intravenously

Primary Outcomes

Measure
Progression Free Survival
time frame: Baseline to measured progressive disease or date of death from any cause (estimate 2 years)

Secondary Outcomes

Measure
Number of participants achieving an objective Tumor response, (Objective Response Rate)
time frame: Baseline to date of tumor response or measured progressive disease or date of death from any cause (estimate 2 years)
Overall Survival
time frame: Baseline to date of death from any cause (estimate 2 years)
Duration of Overall Response
time frame: Date of response to date of progressive disease (estimate 2 years)

Eligibility Criteria

Male or female participants at least 18 years old.

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. Patients 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 patient'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

Additional Information

Official title A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.