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| ID | Type | Description | Link |
|---|---|---|---|
| CP02-0860 | Other Identifier | CDER | |
| CP13-0811 | Other Identifier | ImClone, LLC | |
| I5A-IE-JAEF | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.
Participants with Stage IIIb or IV non-small cell lung cancer (NSCLC) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus [vs.] nonsquamous).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab) | Experimental | Cycles repeat every 3 weeks for first 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met *Cisplatin will replace Carboplatin. Gemcitabine/Carboplatin/Cetuximab (GCC) plus cixutumumab will change to Gemcitabine/Cisplatin/Cetuximab (GCiC) plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab) |
|
| GCiC (Gemcitabine/Cisplatin/Cetuximab) | Active Comparator | Cycles repeat every 3 weeks for 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met *Cisplatin will replace Carboplatin. GCC plus cixutumumab will change to GCiC plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 1000 milligrams per square meter (mg/m^2) on Days 1 and 8 of each cycle [First 6 cycles (18 weeks)] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. 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 LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated * 100. | Randomization to measured progressive disease (PD) (up to 16.9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact. | Randomization to death due to any cause or censor (up to 30.4 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E-mail: ClinicalTrials@ ImClone.com | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Anniston | Alabama | 36207 | United States | ||
| ImClone Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine/Carboplatin/Cetuximab (GCC) | Gemcitabine: 1000 milligrams per square meter (mg/m^2) on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 once every week (Q1W) of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 once every 2 weeks (Q2W) in the subsequent cycles (2-week cycles). Carboplatin: Area under the curve (AUC) = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cisplatin | Drug | 75 mg/m^2 on Day 1 of each cycle [First 6 cycles (18 weeks)] |
|
| IMC-A12 (cixutumumab) | Biological | 6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle) [First 6 cycles (18 weeks)] |
|
|
| Cetuximab | Biological | 400 mg/m^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m^2 once per week thereafter [First 6 cycles (18 weeks)] |
|
|
| IMC-A12 (cixutumumab) | Biological | 10 mg/kg IV infusion, administered once every 2 weeks (Maintenance therapy) |
|
|
| Cetuximab | Biological | 500 mg/m^2 IV infusion, administered once every 2 weeks (Maintenance therapy) |
|
|
| Carboplatin | Drug | Area under the curve (AUC) = 5, Day 1 of each cycle [First 6 cycles (18 weeks)] *Carboplatin will be replaced by Cisplatin |
|
| Progression-Free Survival (PFS) |
PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact. |
| Randomization to PD or death due to any cause or censor (up to 16.9 months) |
| Time To Progression (TTP) | TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact. | Randomization to months until PD or censor (up to 16.9 months) |
| Duration of Response | The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression. | Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months) |
| Number of Participants With Adverse Events (AEs) or Deaths | Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report. | Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up |
| Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity) | Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy |
| Maximum Concentration (Cmax) of Cixutumumab at Study Day 1 | Day 1 |
| Cmax of Cixutumumab for Cycle 1 | Week 1 (Cycle 1, Day 1) |
| Cmax of Cixutumumab for Cycle 3 | Week 7 (Cycle 3, Day 1) |
| Cmax of Cixutumumab Cycle 5 | Week 13 (Cycle 5, Day 1) |
| Minimum Concentration (Cmin) of Cixutumumab at Study Day 1 | Day 1 |
| Cmin of Cixutumumab for Cycle 1 | Week 1 (Cycle 1, Day 1) |
| Cmin of Cixutumumab for Cycle 3 | Week 7 (Cycle 3, Day 1) |
| Cmin of Cixutumumab for Cycle 5 | Week 13 (Cycle 5, Day 1) |
| La Jolla |
| California |
| 92093 |
| United States |
| ImClone Investigational Site | Orange | California | 92868 | United States |
| ImClone Investigational Site | Orlando | Florida | 32806 | United States |
| ImClone Investigational Site | Atlanta | Georgia | 30341 | United States |
| ImClone Investigational Site | Chicago | Illinois | 60612 | United States |
| ImClone Investigational Site | Chicago | Illinois | 60637 | United States |
| ImClone Investigational Site | Albuquerque | New Mexico | 87131 | United States |
| ImClone Investigational Site | New York | New York | 10011 | United States |
| ImClone Investigational Site | New York | New York | 10021 | United States |
| ImClone Investigational Site | New York | New York | 10032 | United States |
| ImClone Investigational Site | Cincinnati | Ohio | 45247 | United States |
| FG001 | GCC Plus Cixutumumab | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1 and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cixutumumab: 6 milligrams per kilogram (mg/kg) intravenous (IV) infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
| FG002 | Gemcitabine/Cisplatin/Cetuximab (GCiC) | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1 and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
| FG003 | GCiC Plus Cixutumumab | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1 and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
| COMPLETED |
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| NOT COMPLETED |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine/Carboplatin/Cetuximab (GCC) | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
| BG001 | GCC Plus Cixutumumab | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
| BG002 | Gemcitabine/Cisplatin/Cetuximab (GCiC) | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
| BG003 | GCiC Plus Cixutumumab | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycle). Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
| 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 | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters (cm) |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms (kg) |
| |||||||||||||||
| Body Surface Area (BSA) | BSA is the measured or calculated surface area of a human body based on body weight and height. | Mean | Standard Deviation | square meters (m^2) |
| ||||||||||||||
| Eastern Cooperative Oncology Status Performance Status (ECOG PS) Score | ECOG performance status was used to classify participants according to their functional impairment. Score 0 = fully active, able to carry on all pre-disease performance without restriction. Score 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work. | Count of Participants | Participants | No |
| ||||||||||||||
| Randomization Stratum | 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 | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. 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 LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated * 100. | All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to measured progressive disease (PD) (up to 16.9 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact. | All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 6, GCiC Plus cixutumumab = 6. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol. | Posted | Median | 95% Confidence Interval | months | Randomization to death due to any cause or censor (up to 30.4 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact. | All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 2, GCiC Plus cixutumumab = 10. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol. | Posted | Median | 95% Confidence Interval | months | Randomization to PD or death due to any cause or censor (up to 16.9 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Time To Progression (TTP) | TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact. | All participants (pts) randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 9, GCiC Plus Cixutumumab = 12. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol. | Posted | Median | 95% Confidence Interval | months | Randomization to months until PD or censor (up to 16.9 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response | The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression. | All pts randomized to GCiC and GCiC Plus Cixutumumab arms and who had CR or PR, except 1 pt in GCiC group eliminated d/t PR after starting additional treatment. Participants censored: GCiC = 0, GCiC Plus Cixutumumab = 1. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) due to the amended protocol. | Posted | Median | 95% Confidence Interval | months | Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) or Deaths | Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report. | All randomized participants. | Posted | Count of Participants | Participants | No | Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up |
| ||||||||||||||||||||||||||||||
| Secondary | Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity) | Zero participants analyzed. Analysis was not performed due to lack of an appropriate validated assay. | Posted | Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy |
| ||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) of Cixutumumab at Study Day 1 | Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze. | Posted | Day 1 |
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| Secondary | Cmax of Cixutumumab for Cycle 1 | Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze. | Posted | Week 1 (Cycle 1, Day 1) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Cmax of Cixutumumab for Cycle 3 | Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze. | Posted | Week 7 (Cycle 3, Day 1) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Cmax of Cixutumumab Cycle 5 | Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze. | Posted | Week 13 (Cycle 5, Day 1) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Minimum Concentration (Cmin) of Cixutumumab at Study Day 1 | Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze. | Posted | Day 1 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Cmin of Cixutumumab for Cycle 1 | Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze. | Posted | Week 1 (Cycle 1, Day 1) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Cmin of Cixutumumab for Cycle 3 | Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze. | Posted | Week 7 (Cycle 3, Day 1) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Cmin of Cixutumumab for Cycle 5 | Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze. | Posted | Week 13 (Cycle 5, Day 1) |
|
Not provided
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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 | Gemcitabine/Carboplatin/Cetuximab (GCC) | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. | 4 | 4 | 4 | 4 | ||
| EG001 | GCC Plus Cixutumumab | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. | 5 | 6 | 6 | 6 | ||
| EG002 | Gemcitabine/Cisplatin/Cetuximab (GCiC) | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. | 20 | 29 | 29 | 29 | ||
| EG003 | GCiC Plus Cixutumumab | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. | 15 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gallbladder non-functioning | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Wound infection pseudomonas | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Catheter thrombosis | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood amylase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| C557414 | cixutumumab |
| D000068818 | Cetuximab |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| 1 = Ambulatory, Restricted Work Activity |
|
| Nonsquamous |
|
|
|
| OG001 | GCiC Plus Cixutumumab | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
|
|
| OG001 | GCiC Plus Cixutumumab | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
|
|
| OG001 |
| GCiC Plus Cixutumumab |
Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
|
|
| OG002 | Gemcitabine/Cisplatin/Cetuximab (GCiC) | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
| OG003 | GCiC Plus Cixutumumab | Gemcitabine: 1000 mg/m^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks). Cisplatin: 75 mg/m^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks). Cetuximab: Initial dose of 400 mg/m^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m^2 Q2W in the subsequent cycles (2-week cycles). Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. |
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