Brief Summary

Part A: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer. Part B: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Dec 2009

Geographic Reach

3 countries

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

December 1, 2009

Completed

Same day until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed

5.4 years until next milestone

Results Posted

Study results publicly available

December 4, 2017

Completed

Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

2.6 years

First QC Date

December 1, 2009

Results QC Date

September 27, 2017

Last Update Submit

September 9, 2019

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate)
The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100.
Date of enrollment to date of measured progressive disease up to 99.6 weeks
Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)
Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
Date of enrollment to date of measured progressive disease up to 18.1 weeks

Secondary Outcomes (9)

Part A: Progression-Free Survival
Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks
Part B: Progression-Free Survival
Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks
Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)
Date of enrollment to date of measured progressive disease 99.6 weeks
Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate)
Date of enrollment to date of measured progressive disease up to 18.1 weeks
Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)
Days 1,5 and 9 of Cycle 1 (21-day cycle)
+4 more secondary outcomes

Study Arms (2)

Part A LY2523355

EXPERIMENTAL

8 milligrams per square meter (mg/m²) per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 5, 9 of each 21-day cycle, until disease progression or unacceptable toxicity.

Drug: LY2523355

Part B LY2523355

EXPERIMENTAL

5 or 6 mg/m² per dose based on participant's body surface area, administered intravenously as a 1-hour infusion on Days 1, 2, 3 plus granulocyte colony-stimulating factor (G-CSF) support administered subcutaneously beginning on Day 4 of each 21-day cycle, until disease progression or unacceptable toxicity.

Drug: LY2523355Drug: Granulocyte colony-stimulating factor (G-CSF)

Interventions

LY2523355DRUG

Administered intravenously as a 1-hour infusion

Part A LY2523355Part B LY2523355

Granulocyte colony-stimulating factor (G-CSF)DRUG

Administered subcutaneously

Part B LY2523355

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Have histological or cytological evidence of extensive-disease small-cell lung cancer
Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Have received at least 1 prior chemotherapy regimen with agents known to provide clinical benefit for small-cell lung cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy
Have discontinued all previous therapies for cancer, including chemotherapy, biologic therapy, hormone therapy, or radiotherapy. Participants must have recovered from the acute effects of therapy (except alopecia and fatigue) before study enrollment
Part A: Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group scale
Part B: Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

You may not qualify if:

Have received treatment within 28 days of the first dose of LY2523355 with a drug that has not received regulatory approval for any indication
Have a mixed histological diagnosis of small-cell lung cancer and non-small-cell lung cancer
Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study
Part A: Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic participants without history of CNS metastases is not required
Part B: Have symptomatic, untreated, or uncontrolled CNS metastases or a history of CNS metastases. Participants who have received prophylactic radiation are not excluded. Screening of asymptomatic participants without history of CNS metastases is not required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (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.

Torrington, Connecticut, 06790, United States

Location

Athens, Georgia, 30607, United States

Location

Marietta, Georgia, 30060, United States

Location

Scarborough, Maine, 04074, United States

Location

Cherry Hill, New Jersey, 08003, United States

Location

Albuquerque, New Mexico, 87131, United States

Location

Charleston, South Carolina, 29425, United States

Location

Memphis, Tennessee, 38138, United States

Location

Bucharest, 022328, Romania

Location

Cluj-Napoca, 3400, Romania

Location

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

litronesibGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 3, 2009

Study Start

December 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 17, 2019

Results First Posted

December 4, 2017

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

RO(2)KR(1)US(8)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (2)

Part A LY2523355

Part B LY2523355

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations