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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-MC-S034 | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the first-line treatment of participants with advanced stage non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin |
|
| B | Placebo Comparator | Pemetrexed + Carboplatin + Bevacizumab + Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 1125 milligram (mg) loading dose then 500 mg, oral, daily until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the time from date of randomization to the first observation of progressive disease (PD) or death due to any cause. For participants not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of the last objective progression-free assessment. For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to objective disease progression or death, PFS was censored at the date of the last objective progression-free assessment prior to the initiation of post-discontinuation anticancer therapy. | Randomization to measured PD or death from any cause up to 12.2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) | Tumor response rate was defined as number of participants with overall best response of CR or PR over number of protocol qualified participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case, no new lesions may have appeared. Percentage of participants was calculated as: (number of participants with CR or PR/ number of participants qualified for tumor response analysis) × 100. |
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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 (UTC/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. | Bentonville | Arkansas | 72712 |
Participant flow reports those participants who discontinued from study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin | Combination biochemotherapy: Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: Area under the curve (AUC) 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 milligrams/kilogram (mg/kg) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 (28 days), followed by 500 mg oral daily dose for 3 cycles Maintenance therapy: Enzastaurin: 500 mg oral daily dose for 21-day cycles until disease progression Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| pemetrexed | Drug | 500 milligrams per square meter (mg/m^2), intravenously ( IV), Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles every (q) 21 days x 3 cycles |
|
|
| carboplatin | Drug | Area under the curve (AUC) 6, IV, Day 8 cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles |
|
| bevacizumab | Drug | 15 milligrams/kilogram (mg/kg), IV, Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles |
|
| Placebo | Drug | oral, daily |
|
| Randomization to measured progressive disease or death from any cause up to 12.2 months |
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data cutoff, OS was censored at the last contact date. | Randomization to date of death up to 14.3 months |
| Time to Progressive Disease (TTPD) | TTPD was defined as the time from the date of randomization until the first date of objectively determined progressive disease (PD). For participants who died without objective PD (including death from study disease), TTPD was censored at the date of the last objective progression-free disease assessment. For participants not known to have died as of the data cutoff and did not have PD, TTPD was censored at the date of the last objective progression-free disease assessment. | Randomization to measured PD or death from any cause up to 12.2 months |
| Duration of Response (DoR) | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death from any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions and PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs. For participants who died without progressive disease or who were alive, DoR was censored at the last contact of progression free assessment. For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to PD, DoR was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation anticancer therapy. Due to early study closure, DoR was not analyzed. | Time of response to disease progression or death from any cause up to 12.2 months |
| Pharmacology Toxicity and Adverse Events (AEs) | Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs. Participants who died due to progressive disease (PD) or an AE while on treatment and or died during the 30 day post-treatment follow-up are included. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | Randomization up to 14.3 months and 30-day follow-up |
| United States |
| 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. | Chicago | Illinois | 60611 | United States |
| 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. | Galesburg | Illinois | 61401 | United States |
| 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. | Bloomington | Indiana | 47403 | United States |
| 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. | Evansville | Indiana | 47714 | United States |
| 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. | Fort Wayne | Indiana | 46815 | United States |
| 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. | Indianapolis | Indiana | 46202 | United States |
| 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. | Lafayette | Indiana | 47904 | United States |
| 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. | Muncie | Indiana | 47303 | United States |
| 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. | South Bend | Indiana | 46601 | United States |
| 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. | Jackson | Michigan | 49201 | United States |
| 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. | Omaha | Nebraska | 68114 | United States |
| FG001 | Pemetrexed + Carboplatin + Bevacizumab + Placebo | Combination biochemotherapy: Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles Maintenance therapy: Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression Placebo: Oral tablets daily for 21-day cycles until progressive disease |
| Received at Least 1 Dose of Study Drug |
|
| Entered Maintenance |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin | Combination biochemotherapy: Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: Area under the curve (AUC) 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 milligrams/kilogram (mg/kg) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 (28 days), followed by 500 mg oral daily dose for 3 cycles Maintenance therapy: Enzastaurin: 500 mg oral daily dose for 21-day cycles until disease progression Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression |
| BG001 | Pemetrexed + Carboplatin + Bevacizumab + Placebo | Combination biochemotherapy: Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles Maintenance therapy: Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression Placebo: Oral tablets daily for 21-day cycles until progressive disease |
| BG002 | 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 |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG Performance Status classifies participants according to their functional impairment. | Count of Participants | Participants | No |
| ||||||||||||||
| Prior therapy | Prior therapy included radiation, surgery and chemotherapy in an adjuvant setting. | Count of Participants | Participants | No |
| ||||||||||||||
| Disease Stage | Cancer staging is a process describing the severity of the cancer, size of the tumor and how far it has spread from the original location. Stage IIIB: a tumor of any size that has spread (metastasized) to distant lymph nodes, has invaded other structures in the chest (such as the heart or esophagus), or has a malignant pleural effusion (fluid build-up containing cancer cells between the layers lining the lungs). Stage IV: a tumor of any size that has spread (metastasized) to another region of the body or to another lobe of the lungs. | 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 | Progression-Free Survival (PFS) | PFS was defined as the time from date of randomization to the first observation of progressive disease (PD) or death due to any cause. For participants not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of the last objective progression-free assessment. For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to objective disease progression or death, PFS was censored at the date of the last objective progression-free assessment prior to the initiation of post-discontinuation anticancer therapy. | All randomized participants identified by assigned treatment group. Number of participants censored: Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin = 5; Pemetrexed + Carboplatin + Bevacizumab + Placebo = 2. | Posted | Number | 95% Confidence Interval | months | Randomization to measured PD or death from any cause up to 12.2 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) | Tumor response rate was defined as number of participants with overall best response of CR or PR over number of protocol qualified participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case, no new lesions may have appeared. Percentage of participants was calculated as: (number of participants with CR or PR/ number of participants qualified for tumor response analysis) × 100. | All randomized participants identified by assigned treatment group. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to measured progressive disease or death from any cause up to 12.2 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data cutoff, OS was censored at the last contact date. | All randomized participants identified by assigned treatment group. Participants censored: Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin = 12; Pemetrexed + Carboplatin + Bevacizumab + Placebo = 9. | Posted | Median | 95% Confidence Interval | months | Randomization to date of death up to 14.3 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progressive Disease (TTPD) | TTPD was defined as the time from the date of randomization until the first date of objectively determined progressive disease (PD). For participants who died without objective PD (including death from study disease), TTPD was censored at the date of the last objective progression-free disease assessment. For participants not known to have died as of the data cutoff and did not have PD, TTPD was censored at the date of the last objective progression-free disease assessment. | All randomized participants. | Posted | Median | 95% Confidence Interval | Months | Randomization to measured PD or death from any cause up to 12.2 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death from any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions and PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs. For participants who died without progressive disease or who were alive, DoR was censored at the last contact of progression free assessment. For participants who received subsequent anticancer therapy (after discontinuation from all study treatment) prior to PD, DoR was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation anticancer therapy. Due to early study closure, DoR was not analyzed. | All randomized participants. Participants censored: Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin = 16; Pemetrexed + Carboplatin + Bevacizumab + Placebo = 14. | Posted | Median | 95% Confidence Interval | Months | Time of response to disease progression or death from any cause up to 12.2 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacology Toxicity and Adverse Events (AEs) | Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs. Participants who died due to progressive disease (PD) or an AE while on treatment and or died during the 30 day post-treatment follow-up are included. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Randomization up to 14.3 months and 30-day follow-up |
|
Randomization up to 14.3 months and 30-day follow-up
Study-specific clinical outcomes due to progressive disease 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 | Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin | Combination biochemotherapy: Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: Area under the curve (AUC) 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 milligrams/kilogram (mg/kg) intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Enzastaurin: 1125 milligram (mg) loading dose on Day 1 of Cycle 1 (28 days), followed by 500 mg oral daily dose for 3 cycles Maintenance therapy: Enzastaurin: 500 mg oral daily dose for 21-day cycles until disease progression Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression | 6 | 20 | 19 | 20 | ||
| EG001 | Pemetrexed + Carboplatin + Bevacizumab + Placebo | Combination biochemotherapy: Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles Maintenance therapy: Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression Placebo: Oral tablets daily for 21-day cycles until progressive disease | 7 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 9.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | 9.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 9.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 9.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Confusional state | Nervous system disorders | 9.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | 9.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | 9.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 9.0 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | 9.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | 9.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | 9.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 9.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Peritoneal infection | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 9.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 9.0 | Systematic Assessment |
| |
| Hyperhidrosis | General disorders | 9.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 9.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 9.0 | Systematic Assessment |
| |
| Pain | General disorders | 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 9.0 | Systematic Assessment |
| |
| Urticaria | Immune system disorders | 9.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 9.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | 9.0 | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | 9.0 | Systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | 9.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | 9.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 9.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 9.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 9.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 9.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 9.0 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Investigations | 9.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | 9.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 9.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 9.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 9.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Hypothyroidism | Metabolism and nutrition disorders | 9.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 9.0 | Systematic Assessment |
| |
| Confusional state | Nervous system disorders | 9.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 9.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 9.0 | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | 9.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | 9.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | 9.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 9.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 9.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 9.0 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | 9.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | 9.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | 9.0 | Systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | 9.0 | Systematic Assessment |
| |
| Hot flush | Reproductive system and breast disorders | 9.0 | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Chest pain | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Pulmonary fistula | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | 9.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | 9.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 9.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 9.0 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | 9.0 | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | 9.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 9.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 9.0 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | 9.0 | Systematic Assessment |
| |
| Dizziness | Vascular disorders | 9.0 | Systematic Assessment |
| |
| Epistaxis | Vascular disorders | 9.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | 9.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 9.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 9.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Vascular disorders | 9.0 | Systematic Assessment |
| |
| Respiratory tract haemorrhage | Vascular disorders | 9.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| 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 |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 - Ambulatory, Restricted Strenuous Activity |
|
| No |
|
| Stage IV |
|
| OG001 | Pemetrexed + Carboplatin + Bevacizumab + Placebo | Combination biochemotherapy: Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles Maintenance therapy: Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression Placebo: Oral tablets daily for 21-day cycles until progressive disease |
|
|
|
Combination biochemotherapy:
Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles
Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles
Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles
Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles
Maintenance therapy:
Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression
Placebo: Oral tablets daily for 21-day cycles until progressive disease
|
|
|
| Pemetrexed + Carboplatin + Bevacizumab + Placebo |
Combination biochemotherapy: Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles Maintenance therapy: Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression Placebo: Oral tablets daily for 21-day cycles until progressive disease |
|
|
| OG001 | Pemetrexed + Carboplatin + Bevacizumab + Placebo | Combination biochemotherapy: Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles Maintenance therapy: Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycle until disease progression Placebo: Oral tablets daily for 21-day cycles until progressive disease |
|
|
Combination biochemotherapy: Pemetrexed: 500 mg/m^2 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Carboplatin: AUC 6 intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Bevacizumab: 15 mg/kg intravenously on Day 8 of Cycle 1 (28 days), then on Day 1 of subsequent cycles every 21 days for 3 cycles Placebo: Oral tablets daily to complete Cycle 1 (28 days), then subsequent 21-day cycles for 3 cycles Maintenance therapy: Bevacizumab: 15 mg/kg intravenously on Day 1 of every 21-day cycles until disease progression Placebo: Oral tablets daily for 21-day cycles until progressive |
|
|