A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01439568
• Collaborator: (none)
• Enrollment: 90
• Locations: 15
• Arms: 2
• Duration (Months): 59
• Patients Per Site: 6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Extensive Stage Small Cell Lung Carcinoma	Drug: LY2510924; Drug: Carboplatin; Drug: Etoposide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY2510924 + Carboplatin + Etoposide 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: LY2510924; Administered subcutaneous injection; Drug: Carboplatin; Administered intravenously; Drug: Etoposide; Administered intravenously
Active Comparator: Carboplatin + Etoposide 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: Carboplatin; Administered intravenously; Drug: Etoposide; Administered intravenously

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [Randomization to Measured Progressive Disease or Date of Death from Any Cause (Up To 59 Months)]

   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.

Secondary Outcome Measures

1. 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)]

   ORR is defined as the number of participants with a best response of CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.

2. Overall Survival (OS) [Randomization to Date of Death from Any Cause (Up To 59 Months)]

   Overall survival (OS) is defined as the time from the randomization to the date of death from any cause. For participants who are still alive as of the data cutoff date, OS time will be censored on the date of the participant's last contact (last contact for participants in postdiscontinuation is last known alive date in mortality status).

3. Duration of Overall Response (DOR) [Date of Response to Date of Progressive Disease (Up To 59 Months)]

   DOR was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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	United States	80218
2	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	United States	33916
3	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	United States	32804
4	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	United States	32503
5	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	United States	60637
6	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	United States	20817
7	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	United States	65804
8	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	United States	68114
9	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	United States	45242
10	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	United States	29605
11	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	United States	37404
12	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	United States	38120
13	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.	Nashville	Tennessee	United States	37203
14	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 Worth	Texas	United States	76104
15	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.	Richmond	Virginia	United States	23230

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01439568
• Other Study ID Numbers: 14242; I2V-MC-CXAC
• First Posted: Sep 23, 2011
• Last Update Posted: Jul 23, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Eli Lilly and Company: Cancer; Lung; Metastasis
• Additional relevant MeSH terms: Carcinoma; Lung Neoplasms; Small Cell Lung Carcinoma; Carboplatin; Etoposide

Study Results

Participant Flow

Pre-assignment Detail	Participants who died (any cause) or had disease progression were considered to be study completers.

Arm/Group Title	LY2510924 + Carboplatin + Etoposide	Carboplatin + Etoposide
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	47	43
Received at Least One Dose of Study Drug	47	43
COMPLETED	44	41
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	LY2510924 + Carboplatin + Etoposide	Carboplatin + Etoposide	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	47	43	90
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.69 (9.033)	67.07 (8.328)	65.31 (8.820)
Sex: Female, Male (Count of Participants)
Female	25 53.2%	26 60.5%	51 56.7%
Male	22 46.8%	17 39.5%	39 43.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 4.7%	2 2.2%
Not Hispanic or Latino	45 95.7%	40 93%	85 94.4%
Unknown or Not Reported	2 4.3%	1 2.3%	3 3.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.1%	0 0%	1 1.1%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 6.4%	2 4.7%	5 5.6%
White	43 91.5%	40 93%	83 92.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 2.3%	1 1.1%
Region of Enrollment (Count of Participants)
United States	47 100%	43 100%	90 100%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Description	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.
Time Frame	Randomization to Measured Progressive Disease or Date of Death from Any Cause (Up To 59 Months)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation.The number of participants censored were LY2510924 + Carboplatin + Etoposide=13 and Carboplatin + Etoposide=7.

Arm/Group Title	LY2510924 + Carboplatin + Etoposide	Carboplatin + Etoposide
Arm/Group Description	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.	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.
Measure Participants	47	42
Median (95% Confidence Interval) [Months]	5.88	5.85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LY2510924 + Carboplatin + Etoposide, Carboplatin + Etoposide
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8072
	Comments
	Method	Logrank Test
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.0608
	Confidence Interval	(2-Sided) 95%; 0.6598 to 1.7055
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])
Description	ORR is defined as the number of participants with a best response of CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.
Time Frame	Baseline to Date of Tumor Response or Measured Progressive Disease or Date of Death from any Cause (Up to 59 Months)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation.

Arm/Group Title	LY2510924 + Carboplatin + Etoposide	Carboplatin + Etoposide
Arm/Group Description	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.	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.
Measure Participants	47	42
Count of Participants [Participants]	35 74.5%	34 79.1%

3. Secondary Outcome

Title	Overall Survival (OS)
Description	Overall survival (OS) is defined as the time from the randomization to the date of death from any cause. For participants who are still alive as of the data cutoff date, OS time will be censored on the date of the participant's last contact (last contact for participants in postdiscontinuation is last known alive date in mortality status).
Time Frame	Randomization to Date of Death from Any Cause (Up To 59 Months)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation. The numbers of participants censored were LY2510924 + Carboplatin + Etoposide= 4 and Carboplatin + Etoposide=3.

Arm/Group Title	LY2510924 + Carboplatin + Etoposide	Carboplatin + Etoposide
Arm/Group Description	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.	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.
Measure Participants	47	42
Median (95% Confidence Interval) [Months]	9.72	11.14

4. Secondary Outcome

Title	Duration of Overall Response (DOR)
Description	DOR was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame	Date of Response to Date of Progressive Disease (Up To 59 Months)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation. The number of participants censored were LY2510924 + Carboplatin + Etoposide=47 and Carboplatin + Etoposide=42.

Arm/Group Title	LY2510924 + Carboplatin + Etoposide	Carboplatin + Etoposide
Arm/Group Description	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.	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.
Measure Participants	47	42
Median (95% Confidence Interval) [Months]	4.83	4.67

Adverse Events

Adverse Event Reporting Description	All participants who received at least one dose of study drug.
Arm/Group Title	LY2510924 + Carboplatin + Etoposide		Carboplatin + Etoposide
Arm/Group Description	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.		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.
All Cause Mortality
	LY2510924 + Carboplatin + Etoposide		Carboplatin + Etoposide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LY2510924 + Carboplatin + Etoposide		Carboplatin + Etoposide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/47 (51.1%)		13/43 (30.2%)
Blood and lymphatic system disorders
Anaemia	1/47 (2.1%)	1	0/43 (0%)	0
Febrile neutropenia	2/47 (4.3%)	3	0/43 (0%)	0
Leukocytosis	1/47 (2.1%)	1	0/43 (0%)	0
Neutropenia	1/47 (2.1%)	1	1/43 (2.3%)	1
Thrombocytopenia	1/47 (2.1%)	1	1/43 (2.3%)	1
Cardiac disorders
Atrial fibrillation	1/47 (2.1%)	2	0/43 (0%)	0
Cardiac arrest	0/47 (0%)	0	1/43 (2.3%)	1
Myocardial infarction	1/47 (2.1%)	1	0/43 (0%)	0
Supraventricular tachycardia	0/47 (0%)	0	1/43 (2.3%)	1
Gastrointestinal disorders
Lower gastrointestinal haemorrhage	2/47 (4.3%)	2	0/43 (0%)	0
Nausea	1/47 (2.1%)	1	1/43 (2.3%)	1
General disorders
Asthenia	0/47 (0%)	0	1/43 (2.3%)	1
Chest pain	0/47 (0%)	0	1/43 (2.3%)	1
Infections and infestations
Peridiverticular abscess	1/47 (2.1%)	1	0/43 (0%)	0
Pneumonia	5/47 (10.6%)	6	0/43 (0%)	0
Sepsis	2/47 (4.3%)	3	0/43 (0%)	0
Injury, poisoning and procedural complications
Hip fracture	2/47 (4.3%)	2	1/43 (2.3%)	1
Metabolism and nutrition disorders
Dehydration	0/47 (0%)	0	1/43 (2.3%)	1
Hyponatraemia	1/47 (2.1%)	1	1/43 (2.3%)	1
Hypovolaemia	1/47 (2.1%)	1	0/43 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	1/47 (2.1%)	1	0/43 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm	1/47 (2.1%)	1	0/43 (0%)	0
Nervous system disorders
Ataxia	0/47 (0%)	0	1/43 (2.3%)	1
Cerebrovascular accident	0/47 (0%)	0	1/43 (2.3%)	1
Ruptured cerebral aneurysm	0/47 (0%)	0	1/43 (2.3%)	1
Syncope	0/47 (0%)	0	1/43 (2.3%)	1
Psychiatric disorders
Anxiety	1/47 (2.1%)	1	0/43 (0%)	0
Mental status changes	0/47 (0%)	0	1/43 (2.3%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/47 (2.1%)	1	0/43 (0%)	0
Dyspnoea	1/47 (2.1%)	1	1/43 (2.3%)	1
Hypoxia	1/47 (2.1%)	1	0/43 (0%)	0
Pleural effusion	0/47 (0%)	0	3/43 (7%)	3
Pneumothorax	2/47 (4.3%)	2	0/43 (0%)	0
Respiratory failure	1/47 (2.1%)	1	0/43 (0%)	0
Vascular disorders
Deep vein thrombosis	1/47 (2.1%)	1	0/43 (0%)	0
Hypotension	0/47 (0%)	0	1/43 (2.3%)	1
Other (Not Including Serious) Adverse Events
	LY2510924 + Carboplatin + Etoposide		Carboplatin + Etoposide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/47 (100%)		43/43 (100%)
Blood and lymphatic system disorders
Anaemia	28/47 (59.6%)	94	21/43 (48.8%)	81
Leukocytosis	3/47 (6.4%)	3	1/43 (2.3%)	1
Leukopenia	13/47 (27.7%)	18	4/43 (9.3%)	6
Neutropenia	28/47 (59.6%)	43	22/43 (51.2%)	49
Thrombocytopenia	17/47 (36.2%)	56	17/43 (39.5%)	52
Cardiac disorders
Tachycardia	3/47 (6.4%)	4	2/43 (4.7%)	2
Eye disorders
Vision blurred	3/47 (6.4%)	3	0/43 (0%)	0
Gastrointestinal disorders
Abdominal pain	3/47 (6.4%)	3	3/43 (7%)	3
Constipation	18/47 (38.3%)	20	18/43 (41.9%)	22
Diarrhoea	12/47 (25.5%)	16	9/43 (20.9%)	11
Dyspepsia	5/47 (10.6%)	10	3/43 (7%)	4
Nausea	23/47 (48.9%)	44	19/43 (44.2%)	36
Vomiting	15/47 (31.9%)	21	8/43 (18.6%)	10
General disorders
Asthenia	6/47 (12.8%)	7	6/43 (14%)	7
Chest pain	5/47 (10.6%)	5	0/43 (0%)	0
Fatigue	29/47 (61.7%)	46	25/43 (58.1%)	46
Injection site erythema	3/47 (6.4%)	3	0/43 (0%)	0
Injection site pain	9/47 (19.1%)	11	0/43 (0%)	0
Mucosal inflammation	2/47 (4.3%)	2	3/43 (7%)	3
Oedema peripheral	7/47 (14.9%)	11	10/43 (23.3%)	10
Pain	5/47 (10.6%)	5	4/43 (9.3%)	5
Pyrexia	5/47 (10.6%)	9	3/43 (7%)	3
Infections and infestations
Pneumonia	3/47 (6.4%)	3	3/43 (7%)	3
Upper respiratory tract infection	2/47 (4.3%)	2	3/43 (7%)	3
Urinary tract infection	3/47 (6.4%)	5	5/43 (11.6%)	5
Investigations
Aspartate aminotransferase increased	3/47 (6.4%)	3	2/43 (4.7%)	2
Blood alkaline phosphatase increased	5/47 (10.6%)	5	3/43 (7%)	3
Blood creatinine increased	1/47 (2.1%)	1	4/43 (9.3%)	4
Blood lactate dehydrogenase increased	2/47 (4.3%)	3	3/43 (7%)	3
Blood magnesium decreased	3/47 (6.4%)	3	1/43 (2.3%)	1
Blood uric acid increased	4/47 (8.5%)	4	0/43 (0%)	0
Neutrophil count decreased	3/47 (6.4%)	6	3/43 (7%)	6
Neutrophil count increased	3/47 (6.4%)	6	1/43 (2.3%)	2
Platelet count decreased	3/47 (6.4%)	7	3/43 (7%)	6
Weight decreased	6/47 (12.8%)	6	6/43 (14%)	7
White blood cell count increased	5/47 (10.6%)	9	1/43 (2.3%)	2
Metabolism and nutrition disorders
Decreased appetite	13/47 (27.7%)	15	11/43 (25.6%)	13
Dehydration	8/47 (17%)	9	3/43 (7%)	3
Hyperglycaemia	3/47 (6.4%)	4	2/43 (4.7%)	7
Hyperkalaemia	3/47 (6.4%)	3	3/43 (7%)	5
Hypokalaemia	6/47 (12.8%)	11	5/43 (11.6%)	5
Hypomagnesaemia	5/47 (10.6%)	12	7/43 (16.3%)	10
Hyponatraemia	3/47 (6.4%)	3	7/43 (16.3%)	11
Musculoskeletal and connective tissue disorders
Arthralgia	4/47 (8.5%)	5	6/43 (14%)	6
Back pain	9/47 (19.1%)	10	3/43 (7%)	3
Bone pain	5/47 (10.6%)	12	4/43 (9.3%)	4
Musculoskeletal chest pain	3/47 (6.4%)	4	6/43 (14%)	6
Myalgia	4/47 (8.5%)	5	4/43 (9.3%)	6
Pain in extremity	5/47 (10.6%)	6	3/43 (7%)	4
Nervous system disorders
Dizziness	5/47 (10.6%)	5	4/43 (9.3%)	4
Dysgeusia	6/47 (12.8%)	7	1/43 (2.3%)	1
Headache	5/47 (10.6%)	5	8/43 (18.6%)	8
Syncope	3/47 (6.4%)	3	1/43 (2.3%)	1
Tremor	3/47 (6.4%)	3	1/43 (2.3%)	1
Psychiatric disorders
Anxiety	3/47 (6.4%)	3	4/43 (9.3%)	5
Confusional state	4/47 (8.5%)	4	1/43 (2.3%)	1
Insomnia	11/47 (23.4%)	12	8/43 (18.6%)	9
Respiratory, thoracic and mediastinal disorders
Cough	11/47 (23.4%)	14	12/43 (27.9%)	16
Dyspnoea	14/47 (29.8%)	17	10/43 (23.3%)	13
Dyspnoea exertional	7/47 (14.9%)	7	1/43 (2.3%)	1
Haemoptysis	2/47 (4.3%)	2	3/43 (7%)	5
Oropharyngeal pain	2/47 (4.3%)	2	3/43 (7%)	3
Productive cough	5/47 (10.6%)	5	1/43 (2.3%)	1
Wheezing	4/47 (8.5%)	4	1/43 (2.3%)	1
Skin and subcutaneous tissue disorders
Alopecia	20/47 (42.6%)	27	17/43 (39.5%)	19
Pruritus	4/47 (8.5%)	5	2/43 (4.7%)	2
Rash	4/47 (8.5%)	6	4/43 (9.3%)	4
Vascular disorders
Flushing	4/47 (8.5%)	5	0/43 (0%)	0
Hypotension	4/47 (8.5%)	5	5/43 (11.6%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.