Trial · NCT01025284
A Study for Participants With Small-Cell Lung Cancer
NCT01025284, Phase 2, Completed, Eli Lilly and Company; results first posted 2017-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for Participants With Small-Cell Lung Cancer. Trials, record NCT01025284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01025284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Participants With Small-Cell Lung Cancer
- NCT number
- NCT01025284
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Small Cell Lung Cancer
- Interventions
- LY2523355, Granulocyte colony-stimulating factor (G-CSF)
- First posted
- 2009-12-03
- Last updated
- 2019-09-17
- Results first posted
- 2017-12-04
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | 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. |
| Primary | Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | 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 | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | 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. |
| Secondary | 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 | 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. |
| Secondary | 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) | |
| Secondary | Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 | Day 3 of Cycle 1 (21-day cycle) | |
| Secondary | Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | 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. |
| Secondary | Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | Day 3 of Cycle 1 (21-day cycle) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | Date of enrollment to date of measured progressive disease up to 99.6 weeks | All participants who received at least 1 dose of study drug in Part A. | percentage of participants | NUMBER |
| PRIMARY | Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Date of enrollment to date of measured progressive disease up to 18.1 weeks | All participants who received at least 1 dose of study drug in Part B. | percentage of participants | NUMBER |
| SECONDARY | 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 | All participants who received at least 1 dose of study drug in Part A. The numbers of participants censored are 4. | weeks | MEDIAN |
| SECONDARY | 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 | All participants who received at least 1 dose of study drug in Part B. The numbers of participants censored are 4. | weeks | MEDIAN |
| SECONDARY | Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Date of enrollment to date of measured progressive disease 99.6 weeks | All participants who received at least 1 dose of study drug in Part A. | percentage of participants | NUMBER |
| SECONDARY | 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 | All participants who received at least 1 dose of study drug in Part B. | percentage of participants | NUMBER |
| SECONDARY | 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) | All participants who received 1 dose of study drug on Days 1, 5, and 9 of Cycle 1 and had Cmax samples collected on Days 1, 5, and 9 of Cycle 1 in Part A. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 | Day 3 of Cycle 1 (21-day cycle) | All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had Cmax samples collected on Day 3 of Cycle 1 in Part B. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | Days 1,5 and 9 of Cycle 1 (21-day cycle) | No participants were analyzed due to the very limited pharmacokinetic sampling employed in Part A that did not allow accurate calculation of the AUC(0-∞) on Days 1, 5, and 9 of Cycle 1. | ||
| SECONDARY | Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)] | Day 3 of Cycle 1 (21-day cycle) | All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had pharmacokinetic samples collected on Day 3 of Cycle 1 in Part B that enabled calculation of the AUC(0-∞). | nanograms*hour/milliliter (ng*h/mL) | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | Part A | 2.6 | 90% Confidence Interval 0.1 to 11.9 | percentage of participants | |
| Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Part B | 26.9 | 90% Confidence Interval 13.4 to 44.7 | percentage of participants | |
| Part A: Progression-Free Survival | Part A | 5.3 | 90% Confidence Interval 5.1 to 5.7 | weeks | |
| Part B: Progression-Free Survival | Part B | 6.1 | 90% Confidence Interval 5.6 to 7.4 | weeks | |
| Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate) | Part A | 23.7 | 90% Confidence Interval 12.9 to 37.7 | percentage of participants | |
| Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate) | Part B | 0 | 90% Confidence Interval NA to NA | percentage of participants | |
| Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307) | Part A | LY2523355 Day 1 | 146 | Geometric Coefficient of Variation 69.5 | nanograms/milliliter (ng/mL) |
| Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307) | Part A | LY2523355 Day 5 | 157 | Geometric Coefficient of Variation 91.4 | nanograms/milliliter (ng/mL) |
| Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307) | Part A | LY2523355 Day 9 | 100 | Geometric Coefficient of Variation 420 | nanograms/milliliter (ng/mL) |
| Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307) | Part A | Metabolite Day 1 | 7.17 | Geometric Coefficient of Variation 55.4 | nanograms/milliliter (ng/mL) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A - 8 mg/m²/Day | 38 | |
| Overall Study | STARTED | Part B - 5 mg/m²/Day | 18 | |
| Overall Study | STARTED | Part B - 6 mg/m²/Day | 8 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Part A - 8 mg/m²/Day | 38 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Part B - 5 mg/m²/Day | 18 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Part B - 6 mg/m²/Day | 8 | |
| Overall Study | COMPLETED | Part A - 8 mg/m²/Day | 38 | |
| Overall Study | COMPLETED | Part B - 5 mg/m²/Day | 16 | |
| Overall Study | COMPLETED | Part B - 6 mg/m²/Day | 8 | |
| Overall Study | NOT COMPLETED | Part A - 8 mg/m²/Day | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events390
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A - 8 mg/m²/Day | 9 | 38 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | Part B - 5 mg/m²/Day | 3 | 18 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Part B - 6 mg/m²/Day | 2 | 8 | 4 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Part A - 8 mg/m²/Day | 0 | 38 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Part B - 5 mg/m²/Day | 1 | 18 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Part B - 6 mg/m²/Day | 0 | 8 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Part A - 8 mg/m²/Day | 5 | 38 | 6 |
| other | Leukopenia | Blood and lymphatic system disorders | Part B - 5 mg/m²/Day | 0 | 18 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Part B - 6 mg/m²/Day | 0 | 8 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Part A - 8 mg/m²/Day | 2 | 38 | 2 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A - 8 mg/m²/Day | ||
| Total, all-cause mortality | Part B - 5 mg/m²/Day | ||
| Total, all-cause mortality | Part B - 6 mg/m²/Day | ||
| Total, other adverse events | Part A - 8 mg/m²/Day | 35 | 38 |
| Total, other adverse events | Part B - 5 mg/m²/Day | 18 | 18 |
| Total, other adverse events | Part B - 6 mg/m²/Day | 7 | 8 |
| Total, serious adverse events | Part A - 8 mg/m²/Day | 8 | 38 |
| Total, serious adverse events | Part B - 5 mg/m²/Day | 8 | 18 |
| Total, serious adverse events | Part B - 6 mg/m²/Day | 8 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01025284
GET https://conductscience.org/api/trials/v1/NCT01025284/events?page=2