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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S021 | Other Identifier | Eli Lilly and Company |
Not provided
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Terminated due to lack of efficacy demonstrated in relevant participant population in other clinical trials.
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This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzastaurin + Pemetrexed + Cisplatin | Experimental |
| |
| Placebo + Pemetrexed + Cisplatin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 1125 milligrams (mg) loading dose then 500 mg, oral (po), daily (QD), until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation] | Presented are data that evaluates safety based on toxicity using Common Terminology Criteria for Adverse Events (CTCAE v3.0), SAEs, and discontinuations due to SAEs or other non-serious adverse events (AE's) of study participants. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module. | Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up |
| Part 2: Compare Progression-Free Survival (PFS) Between the 2 Treatment Arms Through the Assessment of Tumor Response | PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have objective progressive disease (PD), PFS was censored at the date of the last objective progression-free assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS was censored at the date of last objective progression-free assessment prior to the initiation of post discontinuation anticancer therapy. PFS was calculated and analyzed based on an alternative definition of censoring; for each participant who is not known to have died or who have had objective disease progression as of the data cut-off date, PFS was censored at the date of last prior contact. Zero participants were analyzed in this outcome as study was terminated early. | Baseline to measured PD up to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: To Evaluate the Safety and Toxicity Profile of Study Treatments | The safety and toxicity profile for Part 2 was defined as serious adverse events (SAEs) and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module. | Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UCT/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Leuven | 3000 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1- Cohort 1 | Cycle 1: 500 milligrams (mg) enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| pemetrexed | Drug | 500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle |
|
|
| cisplatin | Drug | 75 mg/m², IV, every 21 days, for each 21-day cycle |
|
| placebo | Drug | po, QD |
|
| Part 2: Number of Participants With a Complete Response (CR) or Partial Response (PR) (Response Rate) | Response rate was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions. Best response was confirmed by a second assessment in ≥28 days. Response rate was defined as the number of participants with best response of CR or PR divided by the total number of treated participants. Zero participants were analyzed in this outcome as study was terminated early. | Baseline to measured progressive disease (PD) up to 5 months |
| Part 2: Overall Survival (OS) | OS time was defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post discontinuation was equal to the last known alive date in mortality status). Zero participants were analyzed in this outcome as study was terminated early. | Baseline to date of death from any cause up to 5 months |
| Part 2: Duration of Disease Control (DDC) and Response | DDC and response defined as time from complete response (CR), partial response (PR) or stable disease (SD) to first date of objectively determined progressive disease (PD) or death from any cause using RECIST (v1.0) criteria. CR defined as disappearance of all target lesions. PR defined as having ≥30% decrease in sum of longest diameter (LD) of target lesions. PD defined as having ≥20% increase in the sum of the LD of target lesions. SD defined as small changes not meeting above criteria. Participants not known to have died as of data cut-off date, had no objective PD or were lost to follow-up, DCC was censored at date of last objective progression-free assessment (OPFA). Participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objective PD or death were censored at date of last OPFA prior to initiation of post discontinuation anticancer therapy. Zero participants were analyzed in this outcome as study was terminated early. | Baseline to measured PD up to 5 months |
| Part 2: Time to Worsening of Symptoms (TWS) | TWS was measured from the date of study enrollment to the first date of a worsening in any of the 6 Lung Cancer Symptom Scale (LCSS) symptoms (appetite, cough, fatigue, shortness of breath, hemoptysis and pain). Participants marked each symptom on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (as good as it can be/none) to 100 mm (as bad/much as it could be). TWS was also measured individually for each of the 6 symptoms independently and were also measured from the date of enrollment to the first date of worsening in pain. For both measurements, worsening was defined as a 15-mm increase from baseline in the participant-reported score for any symptom. Participants who are not known to have had a worsening TWS were censored at the date of the participant's last LCSS assessment. Zero participants were analyzed in this outcome as study was terminated early. | Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up |
| Part 2: To Assess Biomarkers of the Disease State and Their Correlation to Clinical Outcome | Presented are data that evaluates of biomarkers relevant to the study drug and the disease state of the participant's clinical outcome. Zero participants were analyzed in this outcome as study was terminated early. | Baseline, Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and end of study up to 5 months |
| Belgium |
| 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. | Gauting | 82131 | Germany |
| 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. | GroBhansdorf | D-22927 | Germany |
| 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. | Hamburg | D 21075 | Germany |
| 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. | Heidelberg | 69126 | Germany |
| 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. | Bergamo | 24128 | Italy |
| 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. | Catania | 95100 | Italy |
| 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. | Padova | 35128 | Italy |
| 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. | Trento | 38100 | Italy |
| 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. | Otwock | 05-400 | Poland |
| 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. | Poznan | 60-569 | Poland |
| 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 | 022328 | Romania |
| FG001 | Part 1- Cohort 2 | Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle. |
| FG002 | Part 2- Enzastaurin | Cycle 1: 375 mg enzastaurin po 3 times on Day 1 as a loading dose and 250 mg po BID on Day 2 to 28 of a 28-day cycle, then 500 mg/m² IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycle 2 to 6: 250 mg enzastaurin po BID on Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle. |
| FG003 | Part 2- Placebo | Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle. Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle. |
| Received ≥1 Dose of Any Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of any study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1- Cohort 1 | Cycle 1: 500 mg enzastaurin orally (po) as loading dose on Day 1 and 125 mg orally twice daily (BID) on Days 2 to 28 of 28-day cycle then 500 milligrams per square meter (mg/m²) pemetrexed intravenous (IV) followed by 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 125 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle. |
| BG001 | Part 1- Cohort 2 | Cycle 1: 1125 mg enzastaurin po as loading dose on Day 1 of a 28-day cycle and 250 mg po BID on Days 2 to 28 of 28-day cycle, then 500 mg/m2 pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycles 2 to 6: 250 mg enzastaurin po BID Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle. |
| BG002 | Part 2- Enzastaurin | Cycle 1: 375 mg enzastaurin po 3 times on Day 1 as a loading dose and 250 mg po BID on Day 2 to 28 of a 28-day cycle, then 500 mg/m² IV followed by 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycle 2 to 6: 250 mg enzastaurin po BID on Days 1 to 21 of each 21-day cycle, then 500 mg/m² pemetrexed IV followed by 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle. |
| BG003 | Part 2- Placebo | Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle. Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle. |
| BG004 | Other | 500 mg/m² pemetrexed and 75 mg/m² cisplatin administered intravenously |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Type of Carcinoma | Count of Participants | Participants | No |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation] | Presented are data that evaluates safety based on toxicity using Common Terminology Criteria for Adverse Events (CTCAE v3.0), SAEs, and discontinuations due to SAEs or other non-serious adverse events (AE's) of study participants. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module. | All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Part 2: Compare Progression-Free Survival (PFS) Between the 2 Treatment Arms Through the Assessment of Tumor Response | PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have objective progressive disease (PD), PFS was censored at the date of the last objective progression-free assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS was censored at the date of last objective progression-free assessment prior to the initiation of post discontinuation anticancer therapy. PFS was calculated and analyzed based on an alternative definition of censoring; for each participant who is not known to have died or who have had objective disease progression as of the data cut-off date, PFS was censored at the date of last prior contact. Zero participants were analyzed in this outcome as study was terminated early. | No participant completed a full cycle of therapy and data were not collected for this Outcome Measure. | Posted | Baseline to measured PD up to 5 months |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: To Evaluate the Safety and Toxicity Profile of Study Treatments | The safety and toxicity profile for Part 2 was defined as serious adverse events (SAEs) and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module. | All randomized participants who received at least 1 dose enzastaurin or placebo. | Posted | Count of Participants | Participants | No | Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Number of Participants With a Complete Response (CR) or Partial Response (PR) (Response Rate) | Response rate was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions. Best response was confirmed by a second assessment in ≥28 days. Response rate was defined as the number of participants with best response of CR or PR divided by the total number of treated participants. Zero participants were analyzed in this outcome as study was terminated early. | No participant completed a full cycle of therapy and data were not collected for this Outcome Measure. | Posted | No | Baseline to measured progressive disease (PD) up to 5 months |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Overall Survival (OS) | OS time was defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post discontinuation was equal to the last known alive date in mortality status). Zero participants were analyzed in this outcome as study was terminated early. | No participant completed a full cycle of therapy and data were not collected for this Outcome Measure. | Posted | Baseline to date of death from any cause up to 5 months |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Duration of Disease Control (DDC) and Response | DDC and response defined as time from complete response (CR), partial response (PR) or stable disease (SD) to first date of objectively determined progressive disease (PD) or death from any cause using RECIST (v1.0) criteria. CR defined as disappearance of all target lesions. PR defined as having ≥30% decrease in sum of longest diameter (LD) of target lesions. PD defined as having ≥20% increase in the sum of the LD of target lesions. SD defined as small changes not meeting above criteria. Participants not known to have died as of data cut-off date, had no objective PD or were lost to follow-up, DCC was censored at date of last objective progression-free assessment (OPFA). Participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objective PD or death were censored at date of last OPFA prior to initiation of post discontinuation anticancer therapy. Zero participants were analyzed in this outcome as study was terminated early. | No participant completed a full cycle of therapy and data were not collected for this Outcome Measure. | Posted | Baseline to measured PD up to 5 months |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Time to Worsening of Symptoms (TWS) | TWS was measured from the date of study enrollment to the first date of a worsening in any of the 6 Lung Cancer Symptom Scale (LCSS) symptoms (appetite, cough, fatigue, shortness of breath, hemoptysis and pain). Participants marked each symptom on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (as good as it can be/none) to 100 mm (as bad/much as it could be). TWS was also measured individually for each of the 6 symptoms independently and were also measured from the date of enrollment to the first date of worsening in pain. For both measurements, worsening was defined as a 15-mm increase from baseline in the participant-reported score for any symptom. Participants who are not known to have had a worsening TWS were censored at the date of the participant's last LCSS assessment. Zero participants were analyzed in this outcome as study was terminated early. | No participant completed a full cycle of therapy and data were not collected for this Outcome Measure. | Posted | Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: To Assess Biomarkers of the Disease State and Their Correlation to Clinical Outcome | Presented are data that evaluates of biomarkers relevant to the study drug and the disease state of the participant's clinical outcome. Zero participants were analyzed in this outcome as study was terminated early. | No participant completed a full cycle of therapy and data were not collected for this Outcome Measure. | Posted | Baseline, Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and end of study up to 5 months |
|
Not provided
Study-specific clinical outcomes due to progressive disease (PD) were not considered to be a serious adverse event (SAE) unless the investigator deemed it related to the use of the study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1- Cohort 1 | Cycle 1: 500 mg Enzastaurin orally as loading dose on Day 1 of a 28-day cycle and 125 mg orally twice daily, plus 500 mg/m2 pemetrexed intravenous (IV) and 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2-6: 125 mg Enzastaurin orally twice daily, with 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 1 of each 21-day cycle. | 5 | 9 | 9 | 9 | ||
| EG001 | Part 1- Cohort 2 | Cycle 1: 1125 mg Enzastaurin orally as loading dose on Day 1 of a 28-day cycle and 250 mg orally twice daily starting on Day 2, plus 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 8 of a 28-day cycle. Cycles 2-6: 250 mg Enzastaurin orally twice daily, with 500 mg/m2 pemetrexed IV and 75 mg/m2 cisplatin IV on Day 1 of each 21-day cycle. | 0 | 4 | 4 | 4 | ||
| EG002 | Part 2- Enzastaurin | Cycle 1: 375 mg Enzastaurin orally 3 times on Day 1 of a 28-day cycle and 250 mg orally twice daily starting on Day 2, plus 500 mg/m² pemetrexed intravenously (IV) and 75 mg/m² cisplatin IV on Day 8 of a 28-day cycle. Cycle 2-6: 250 mg Enzastaurin orally twice daily on Days 1 to 21 (21-day cycles) with 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on day 1 of each 21-day cycle. | 2 | 11 | 8 | 11 | ||
| EG003 | Part 2- Placebo | Cycle 1: Placebo was administered orally 3 times on Day 1 and 2 times a day on Days 2-28 (28-day cycle) plus 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on Day 8 of cycle (28-day cycle). Cycle 2-6: Placebo was administered orally 2 time a day on Days 1 to 21 (21-day cycles) plus 500 mg/m² pemetrexed IV and 75 mg/m² cisplatin IV on Day 1 of each 21-day cycle. | 4 | 10 | 8 | 10 | ||
| EG004 | Part 2- Pemetrexed + Cisplatin | Participant was not randomized to Arm A or Arm B but received 500 mg/m² pemetrexed and 75 mg/m² cisplatin administered intravenously but not randomized | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | 10.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | 10.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 10.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | 10.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | 10.0 | Systematic Assessment |
| |
| Blood amylase increased | Investigations | 10.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 10.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 10.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 10.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 10.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | 10.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | 10.0 | Systematic Assessment |
| |
| Abnormal sensation in eye | Eye disorders | 10.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | 10.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | 10.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | 10.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | 10.0 | Systematic Assessment |
| |
| Visual disturbance | Eye disorders | 10.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 10.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 10.0 | Systematic Assessment |
| |
| Face oedema | General disorders | 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 10.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 10.0 | Systematic Assessment |
| |
| Local swelling | General disorders | 10.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 10.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 10.0 | Systematic Assessment |
| |
| Pain | General disorders | 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 10.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 10.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | 10.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 10.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | 10.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 10.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 10.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | 10.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | 10.0 | Systematic Assessment |
| |
| Haemoglobin | Investigations | 10.0 | Systematic Assessment |
| |
| Neutrophil count | Investigations | 10.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | 10.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 10.0 | Systematic Assessment |
| |
| Urine colour abnormal | Investigations | 10.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 10.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 10.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 10.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 10.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 10.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 10.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | 10.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 10.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 10.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 10.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 10.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 10.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | 10.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | 10.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 10.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 10.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 10.0 | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 10.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | 10.0 | Systematic Assessment |
|
This trial was terminated due to lack of efficacy demonstrated in relevant participant population in other clinical trials.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C504878 | enzastaurin |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Male |
|
| Poland |
|
| Germany |
|
| Carcinoma Large Cell: Lung |
|
| Squamous Cell Carcinoma: Lung |
|
| Carcinoma Non-Small Cell: Lung |
|
| Adenocarcinoma, Bronchioalveolar |
|
| 1-Ambulatory, work of a light or sedentary nature |
|
| Discontinued due to AE |
|
| OG001 | Part 2- Placebo | Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle. Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle. |
|
|
|
|
|
| OG001 | Part 2- Placebo | Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle. Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle. |
|
| Part 2- Placebo |
Cycle 1: Placebo was administered po 3 times on Day 1 and BID on Days 2 to 28 of a 28-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 8 of 28-day cycle. Cycle 2 to 6: Placebo was administered po BID on Days 1 to 21 of each 21-day cycle then 500 mg/m² pemetrexed followed by 75 mg/m² cisplatin administered IV on Day 1 of each 21-day cycle. |
|
|