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A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Extensive Stage Small Cell Lung Carcinoma

Thank you

Trial Information

A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

Baseline to measured progressive disease or date of death from any cause (estimate 2 years)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

14242

NCT ID:

NCT01439568

Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

  • Extensive Stage Small Cell Lung Carcinoma
  • Cancer
  • Lung
  • Metastasis
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

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.Jacksonville, Florida  32256
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  60674
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  20817
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.St Joseph, Missouri  64507
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  45267
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  29605
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  38138
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.Bedford, Texas  76022
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.Norfolk, Virginia  23502
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  68114