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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-SB-S109 | Other Identifier | Eli Lilly and Company |
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This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed + Cisplatin | Experimental |
| |
| Pemetrexed + Carboplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | 500 mg/m2, intravenous (IV), every 21 days x 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) | For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group. | Randomization to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Defined as the time from randomization to the date of death from any cause. | Randomization to date of death from any cause (up to 1 year) |
| Number of Participants With Tumor Response (as Basis for Response Rate) |
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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. | Coswig | D-01640 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23332288 | Derived | Schuette WH, Groschel A, Sebastian M, Andreas S, Muller T, Schneller F, Guetz S, Eschbach C, Bohnet S, Leschinger MI, Reck M. A randomized phase II study of pemetrexed in combination with cisplatin or carboplatin as first-line therapy for patients with locally advanced or metastatic non-small-cell lung cancer. Clin Lung Cancer. 2013 May;14(3):215-23. doi: 10.1016/j.cllc.2012.10.001. Epub 2013 Jan 16. |
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136 patients signed informed consent. Of these, 3 patients were discontinued prior to randomization (1x protocol entry criteria not met, 2x patient decision); 133 patients were randomized, 130 patients started study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed + Cisplatin | Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles |
| FG001 | Pemetrexed + Carboplatin | Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cisplatin | Drug | 75 mg/m2, intravenous (IV), every 21 days x 6 cycles |
|
| Carboplatin | Drug | Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles |
|
Best overall response was evaluated using RECIST Criteria which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage.
| Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression |
| Time to Treatment Failure (TTF) | Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first | Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year) |
| Pharmacology Toxicities | Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling. | Every 21-day cycle for up to 6 cycles |
| 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. | Frankfurt | 65929 | 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. | Großhansdorf | D-22927 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Halle | D-06120 | 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. | Hofheim | D-65719 | 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. | Homburg/Saar | 66421 | 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 | D-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. | Leipzig | 04207 | 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. | Lübeck | 23538 | 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. | Mainz | 55131 | 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. | München | 81664 | Germany |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed + Cisplatin | Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles |
| BG001 | Pemetrexed + Carboplatin | Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). | Number | participants |
| |||||||||||||||
| Histopathology | Number | participants |
| ||||||||||||||||
| Presence of Bone and Brain Metastases | Presents specifically participants with bone and brain metastases | Number | participants |
| |||||||||||||||
| Smoking Status | Number | participants |
| ||||||||||||||||
| Stage of disease | For all patients randomized, N=66 for Pemetrexed + Cisplatin, N=67 for Pemetrexed + Carboplatin | Number | participants |
| |||||||||||||||
| Time Since Patient Stopped Smoking | For past smokers only: N=41 for Pemetrexed + Cisplatin, N=42 for Pemetrexed + Carboplatin | Mean | Standard Deviation | years |
| ||||||||||||||
| Use of Tobacco Products | For past and current smokers only: N=56 for Pemetrexed + Cisplatin, N=58 for Pemetrexed + Carboplatin: | Mean | Standard Deviation | years |
|
| 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 Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) | For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group. | Full Analysis Set: All patients randomized who received at least one dose of study drug | Posted | Number | percentage | Randomization to Month 6 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Defined as the time from randomization to the date of death from any cause. | Full Analysis Set: All patients randomized who received at least one dose of study drug | Posted | Median | 95% Confidence Interval | months | Randomization to date of death from any cause (up to 1 year) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tumor Response (as Basis for Response Rate) | Best overall response was evaluated using RECIST Criteria which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage. | Full Analysis Set: All patients randomized who received at least one dose of study drug | Posted | Number | participants | Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure (TTF) | Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first | Full Analysis Set: All patients randomized who received at least one dose of study drug | Posted | Median | 95% Confidence Interval | months | Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacology Toxicities | Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling. | Full Analysis Set: All patients randomized who received at least one dose of study drug | Posted | Number | participants | Every 21-day cycle for up to 6 cycles |
|
|
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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 + Cisplatin | Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles | 22 | 65 | 61 | 65 | ||
| EG001 | Pemetrexed + Carboplatin | Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles | 28 | 65 | 59 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Cerebral fungal infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 9.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Haemoglobinaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| 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 |
| 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 |
Not provided
Not provided
| Male |
|
| 1 - Ambulatory, Restricted Strenuous Activity |
|
| Adenocarcinoma |
|
| Large Cell Carcinoma |
|
| Mixed Cell Carcinoma |
|
| Bronchioalveolar Carcinoma |
|
| NSCLC, Not Otherwise Specified |
|
| Brain Metastases |
|
| Past Smoker |
|
| Current Smoker |
|
| Stage IV (metastatic disease) |
|
| 6-Month PFS Rate |
| 39.3 |
| 2-Sided |
| 95 |
| 27.8 |
| 50.8 |
| No |
| Superiority or Other |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|