A Study for Participants With Small-Cell Lung Cancer

Eli Lilly and Company64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Cancer

Interventions

LY2523355DRUG

Administered intravenously as a 1-hour infusion

Granulocyte colony-stimulating factor (G-CSF)DRUG

Administered subcutaneously

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (11)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Date of enrollment to date of measured progressive disease up to 18.1 weeks

Secondary Outcomes

Part A: Progression-Free Survival

Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment.

Time frame: Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks

Data from ClinicalTrials.gov

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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, United States

Athens, Georgia, United States

Marietta, Georgia, United States

Scarborough, Maine, United States

Cherry Hill, New Jersey, United States

Albuquerque, New Mexico, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Bucharest, Romania

Cluj-Napoca, Romania

...and 1 more locations

Part B: Progression-Free Survival

Time frame: 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)

Time frame: Date of enrollment to date of measured progressive disease 99.6 weeks

Part B: 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 divided by the total number of participants treated, then multiplied by 100.

Time frame: 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)

Time frame: Days 1,5 and 9 of Cycle 1 (21-day cycle)

Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355

Time frame: Day 3 of Cycle 1 (21-day cycle)

Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)]

Due to the very limited pharmacokinetic sampling employed in Part A of the study, the AUC(0-∞) of LY2523355 could not be accurately calculated.

Time frame: Days 1,5 and 9 of Cycle 1 (21-day cycle)

Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)]

Time frame: Day 3 of Cycle 1 (21-day cycle)

Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI)

LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. The LCSS total score was defined as the mean of the 9 items of the scale, with scores range from 0 (for best outcome) to 100 (for worst outcome). ASBI was calculated as the mean of six symptom-specific questions from the LCSS, with scores range from 0 (for best outcome) to 100 (for worst outcome).

Time frame: Baseline and follow-up up to 104 weeks after the first dose of study drug