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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-MC-S102 | Other Identifier | Eli Lilly and Company |
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This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival [PFS], disease control rate, best response rate, time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed (Nonsquamous) | Experimental | Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm |
|
| Pemetrexed + Erlotinib (Nonsquamous) | Experimental | Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm |
|
| Pemetrexed (Squamous) | Experimental | Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm |
|
| Pemetrexed + Erlotinib (Squamous) | Experimental | Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy. | Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate) | Per RECIST: CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salzburg | 5020 |
This is a 2-arm study; however, results for participant disposition and baseline characteristics are presented for 4 groups including each study arm (Pemetrexed and Pemetrexed + Erlotinib) by histology (Nonsquamous and Squamous). Efficacy results are presented for participants with nonsquamous histology only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed (Nonsquamous) | Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity |
| FG001 | Pemetrexed + Erlotinib (Nonsquamous) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Erlotinib | Drug | 150 mg given orally (po), daily (QD), starting on the first day of the first cycle |
|
|
| Pemetrexed | Drug | 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity |
|
|
| Erlotinib | Drug | 150 mg given po, QD, starting on the first day of the first cycle |
|
|
| Baseline to measured PD. Maximum follow-up was from Baseline to 34 months |
| Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate) | CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100. | Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months |
| Time to Treatment Failure (TTTF) | Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than "protocol complete" or "satisfactory response". For participants who discontinued due to "protocol complete" or "satisfactory response", or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date. | Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than "protocol complete" or "satisfactory response". Maximum follow-up was from Baseline to 32.2 months |
| Overall Survival (OS) | OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact. | Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months. |
| Percentage of Participants Surviving at 1 Year | Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method. | Baseline to date of death from any cause up to 1 year |
| Number of Participants With Adverse Events (AEs) | Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | Baseline up to 42.2 months |
| Austria |
| 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. | Vienna | A-1140 | Austria |
| 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. | Bochum | 44791 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Freiburg im Breisgau | 79106 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gauting | 82131 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gerlingen | 70839 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamburg | D 21075 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hanover | 30625 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Immenhausen | 34376 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Trier | 54219 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tübingen | 72076 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ulm | 89075 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Deszk | 6772 | Hungary |
| 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. | Mátraháza | 3233 | Hungary |
| 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. | NyÃregyháza | H-4400 | Hungary |
| 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. | Székesfehérvár | 8000 | Hungary |
| 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. | Alicante | 03010 | Spain |
| 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. | Barcelona | 08036 | Spain |
| 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. | Madrid | 28050 | Spain |
| 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. | Valencia | 46010 | Spain |
| 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. | Linköping | 58185 | Sweden |
| 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. | Lund | 221 85 | Sweden |
| 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. | Solna | 17176 | Sweden |
Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle
| FG002 | Pemetrexed (Squamous) | Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity |
| FG003 | Pemetrexed + Erlotinib (Squamous) | Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed (Nonsquamous) | Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity |
| BG001 | Pemetrexed + Erlotinib (Nonsquamous) | Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle |
| BG002 | Pemetrexed (Squamous) | Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity |
| BG003 | Pemetrexed + Erlotinib (Squamous) | Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle |
| 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 |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 0 - Fully Active
| Number | Participants |
| |||||||||||||||
| Basis for Diagnosis | Number | participants |
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| Initial Pathological Diagnosis | Number | participants |
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| Stage of Disease at Study Entry | Disease Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage 0 - the cancer has not spread beyond the inner lining of the lung Stage I - the cancer is small and hasn't spread to the lymph nodes Stage II - the cancer has spread to some lymph nodes near the original tumor Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver | Number | participants |
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| Smoking status | Number | participants |
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| Pack-years, smokers only | Pack-year equals the number of cigarette packs smoked per day multiplied by the number of years the participant has smoked. For example, 1 pack-year is equal to smoking an average of 20 cigarettes per day (1 pack) for 1 year. | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS) | PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy. | Includes Nonsquamous population only. In Pemetrexed arm, 13 (15.7%) participants censored overall: 12 (14.5%) because of receiving subsequent systemic anticancer therapy. In Pemetrexed + Erlotinib arm, 16 (21.1%) participants censored overall: 9 (11.8%) because of receiving subsequent systemic anticancer therapy. | Posted | Median | 95% Confidence Interval | months | Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months |
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| Secondary | Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate) | Per RECIST: CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100. | Includes nonsquamous population only. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to measured PD. Maximum follow-up was from Baseline to 34 months |
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| Secondary | Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate) | CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100. | Includes nonsquamous population only. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months |
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| Secondary | Time to Treatment Failure (TTTF) | Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than "protocol complete" or "satisfactory response". For participants who discontinued due to "protocol complete" or "satisfactory response", or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date. | Includes nonsquamous population only. | Posted | Median | 95% Confidence Interval | months | Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than "protocol complete" or "satisfactory response". Maximum follow-up was from Baseline to 32.2 months |
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| Secondary | Overall Survival (OS) | OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact. | Pemetrexed arm: 17 (20.5%) participants censored Pemetrexed + Erlotinib arm: 28 (36.8%) participants censored | Posted | Median | 95% Confidence Interval | months | Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months. |
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| Secondary | Percentage of Participants Surviving at 1 Year | Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method. | Includes nonsquamous population only. On the Pemetrexed arm, 17 participants were censored overall and on the Pemetrexed + Erlotinib arm, 28 participants were censored overall. | Posted | Median | 95% Confidence Interval | Percentage participants with OS ≥1 year | Baseline to date of death from any cause up to 1 year |
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| Secondary | Number of Participants With Adverse Events (AEs) | Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | All participants who received at least 1 dose of study drug were analyzed for safety. Nonsquamous and squamous populations are combined. | Posted | Number | participants | Baseline up to 42.2 months |
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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 | Pemetrexed (Nonsquamous and Squamous) | Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity | 43 | 102 | 91 | 102 | ||
| EG001 | Pemetrexed + Erlotinib (Nonsquamous and Squamous) | Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle | 53 | 102 | 98 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Candida pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyothorax | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Superior vena caval occlusion | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
Baseline Characteristics are presented by histology (nonsquamous/squamous) for each arm. Per the protocol amendment of August 2008, study entry criteria were changed to exclude participants with predominantly squamous cell histology.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000069347 | Erlotinib Hydrochloride |
| 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 |
| D011799 | Quinazolines |
Not provided
Not provided
| Male |
|
| African |
|
| Hispanic |
|
| Native American |
|
| East Asian |
|
| West Asian |
|
| Germany |
|
| Spain |
|
| Hungary |
|
| Sweden |
|
| Status 1 |
|
| Status 2 |
|
| Unknown |
|
| Cytological |
|
| Mixed cell (squamous/adenocarcinoma) |
|
| Large cell lung carcinoma |
|
| Bronchioalveolar carcinoma |
|
| Squamous cell carcinoma of the lung |
|
| Unknown |
|
| Stage II |
|
| Stage IIIA |
|
| Stage IIIB |
|
| Stage IV |
|
| Ex-smoker |
|
| Current smoker |
|
| More than 15 pack-years |
|
| Unknown |
|
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| Participants |
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