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Completed

NCT Number: NCT01025284

A Study for Participants With Small-Cell Lung Cancer

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary 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., Bucharest, Romania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2523355

Drug

Administered intravenously as a 1-hour infusion

Granulocyte Colony-Stimulating Factor (G-CSF)

Drug

Administered subcutaneously

Primary outcomes

  1. Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate)

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

    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.

  2. Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)

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

    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.

Secondary outcomes

  1. Part A: Progression-Free Survival

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

    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.

  2. 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

    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.

  3. 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

    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.

  4. Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate)

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

    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.

  5. 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)

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

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

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

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

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

  8. 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)

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

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

    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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Study of LY2523355 in Patients With Extensive-Stage Small-Cell Lung Cancer

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2009
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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