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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-US-S047 | Other Identifier | Eli Lilly and Company |
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The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Pemetrexed + Carboplatin | Experimental | Pemetrexed + Carboplatin |
|
| B: Pemetrexed + Cisplatin | Experimental | Pemetrexed + Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin | MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). | Phase 1 enrollment to the end of study treatment up to Week 11 |
| Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin | MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). | Phase 1 enrollment to the end of study treatment up to Week 11 |
| Phase 2 - Survival Probability at 2 Years | Phase 2 randomization up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs) | Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) >7 days, febrile neutropenia, ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death. |
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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. | Los Angeles | California | 90095 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed + Carboplatin (Study Phase 1) | 500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| cisplatin | Drug | Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43 Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles |
|
| carboplatin | Drug | Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min), administered intravenously, Days 1, 8, 22, 29 and 43 Phase 2 - dosed at AUC 5 mg/mL*min, administered intravenously, every 21 days for 3 cycles |
|
| radiation therapy | Radiation | Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51 Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45 |
|
| Phase 1 enrollment up to Week 11 |
| Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate) | Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | Phase 1 enrollment to the end of the study treatment up to Week 11 |
| Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events | Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section. | Phase 2 randomization to the end of the study treatment up to 30.0 months |
| Phase 2 - Time to Progression | Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | Phase 2 randomization to measured disease progression up to 24 months |
| Phase 2 - Median Survival | Phase 2 randomization to death as the result of any cause up to 30.0 month |
| Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate) | Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | Phase 2 randomization to the end of the treatment up to 30.0 months |
| 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. | Wichita | Kansas | 67214 | 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. | St Louis | Missouri | 63110 | 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. | Las Vegas | Nevada | 89135 | 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. | Burlington | North Carolina | 27216 | 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. | Memphis | Tennessee | 38120 | 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. | Corpus Christi | Texas | 78405 | 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. | Dallas | Texas | 75390 | 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. | Temple | Texas | 76508 | 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. | Delhi | 110085 | India |
| 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. | Trivandrum | 695 011 | India |
| FG001 | Pemetrexed + Cisplatin (Study Phase 1) | 500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy. |
| FG002 | Pemetrexed + Carboplatin (Study Phase 2) | 500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy. |
| FG003 | Pemetrexed + Cisplatin (Study Phase 2) | 500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed + Carboplatin (Study Phase 1) | 500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy. |
| BG001 | Pemetrexed + Cisplatin (Study Phase 1) | 500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy. |
| BG002 | Pemetrexed + Carboplatin (Study Phase 2) | 500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy. |
| BG003 | Pemetrexed + Cisplatin (Study Phase 2) | 500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy. |
| BG004 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin | MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). | All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + carboplatin treatment. | Posted | Number | milligram/milliliter*minute (mg/mL*min) | Phase 1 enrollment to the end of study treatment up to Week 11 |
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| Primary | Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin | MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). | All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + cisplatin treatment. | Posted | Number | milligrams/meter squared (mg/m²) | Phase 1 enrollment to the end of study treatment up to Week 11 |
|
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| Secondary | Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs) | Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) >7 days, febrile neutropenia, ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death. | All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy. | Posted | Number | participants | Phase 1 enrollment up to Week 11 |
| ||||||||||||||||||||||||||||
| Secondary | Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate) | Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy. | Posted | Number | 95% Confidence Interval | percentage of participants | Phase 1 enrollment to the end of the study treatment up to Week 11 |
| |||||||||||||||||||||||||||
| Secondary | Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events | Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section. | All randomized participants who received at least 1 dose of study drug or 1 dose of radiation therapy (RT) during Study Phase 2. | Posted | Number | participants | Phase 2 randomization to the end of the study treatment up to 30.0 months |
| ||||||||||||||||||||||||||||
| Secondary | Phase 2 - Time to Progression | Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | All randomized participants in Study Phase 2. | Posted | Median | 95% Confidence Interval | months | Phase 2 randomization to measured disease progression up to 24 months |
| |||||||||||||||||||||||||||
| Secondary | Phase 2 - Median Survival | All randomized participants in Study Phase 2. | Posted | Median | 95% Confidence Interval | months | Phase 2 randomization to death as the result of any cause up to 30.0 month |
|
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| Secondary | Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate) | Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | All randomization participants in Study Phase 2. | Posted | Number | 95% Confidence Interval | percentage of participants | Phase 2 randomization to the end of the treatment up to 30.0 months |
| |||||||||||||||||||||||||||
| Primary | Phase 2 - Survival Probability at 2 Years | All randomized participants in Study Phase 2. | Posted | Mean | 95% Confidence Interval | percentage survival | Phase 2 randomization up to 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Pemetrexed + Carboplatin | 500 milligrams/meter squared (mg/m²) pemetrexed (pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy. | 6 | 9 | 9 | 9 | ||
| EG001 | Phase 1: Pemetrexed + Cisplatin | 500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Grays (Gy) total dose given 2 Gy/day over 51 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy. | 5 | 13 | 10 | 13 | ||
| EG002 | Phase 2: Pemetrexed + Carboplatin | 500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy. | 21 | 46 | 44 | 46 | ||
| EG003 | Phase 2: Pemetrexed + Cisplatin | 500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy. | 19 | 52 | 51 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11 | Systematic Assessment | One of the events resulted in a discontinuation due to death. |
|
| Oedema peripheral | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 11 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 11 | Systematic Assessment | The event in Pemetrexed + Cisplatin resulted in a discontinuation due to death. |
|
| General physical health deterioration | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Herpes oesophagitis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Mediastinitis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 11 | Systematic Assessment | This event resulted in a discontinuation due to death. |
|
| Pneumonia | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 11 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 11 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 11 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 11 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment | This event resulted in a discontinuation due to death. |
|
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment | The event in Pemetrexed + Cisplatin treatment group resulted in a discontinuation due to death. |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment | This event resulted in a discontinuation due to death. |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Thoracotomy | Surgical and medical procedures | MedDRA 11 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 11 | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | MedDRA 11 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Oedema peripheral | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 11 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 11 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Breakthrough pain | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypoalbuminaemia | Hepatobiliary disorders | MedDRA 11 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 11 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 11 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Blood creatinine | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Blood lactate dehydrogenase | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Haemoglobin | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 11 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 11 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 11 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 11 | 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 |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D011878 | Radiotherapy |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
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| African |
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| Hispanic |
|
| East Asian |
|
| West Asian (Indian sub continent |
|
| India |
|
| Participants |
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|
500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days. Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy. |
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