Conditions

Extensive Stage Small Cell Lung Carcinoma

Keywords

CancerLungMetastasis

Outcome Measures

Primary Outcomes (1)

Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For participants who are still alive at the time of analysis and without evidence of tumor progression, PFS will be censored at the date of the most recent objective progression-free observation. For participants who receive subsequent anticancer therapy (except PCI) prior to objective disease progression or death, PFS will be censored at the date of the last objective progression-free observation prior to the date of subsequent therapy.
Randomization to Measured Progressive Disease or Date of Death from Any Cause (Up To 59 Months)

Secondary Outcomes (3)

Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])
Baseline to Date of Tumor Response or Measured Progressive Disease or Date of Death from any Cause (Up to 59 Months)
Overall Survival (OS)
Randomization to Date of Death from Any Cause (Up To 59 Months)
Duration of Overall Response (DOR)
Date of Response to Date of Progressive Disease (Up To 59 Months)

Study Arms (2)

LY2510924 + Carboplatin + Etoposide

EXPERIMENTAL

LY2510924: 20 milligram (mg) administered once daily as a subcutaneous(SC) 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.

Drug: LY2510924Drug: CarboplatinDrug: Etoposide

Carboplatin + Etoposide

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.

Drug: CarboplatinDrug: Etoposide

Interventions

LY2510924DRUG

Administered subcutaneous injection

LY2510924 + Carboplatin + Etoposide

CarboplatinDRUG

Administered intravenously

Carboplatin + EtoposideLY2510924 + Carboplatin + Etoposide

EtoposideDRUG

Administered intravenously

Carboplatin + EtoposideLY2510924 + Carboplatin + Etoposide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.