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This is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Time | Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS. | Up to 6 years |
| Percentage of Participants With Best Overall Response | Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD. | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Time | Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS. | Up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with locally advanced or metastatic NSCLC that are planned to receive erlotinib containing regimen according to label will be included in this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bludesch | 6712 | Austria |
It was physician's decision to prescribe erlotinib in participants and to document their treatment cycles.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Analysis population included participants who received at least 1 documented treatment cycle.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) Time | Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS. | Analysis population included participants who received at least 2 documented treatment cycles. | Posted | Median | 95% Confidence Interval | months | Up to 6 years |
|
Up to 6 years
Analysis population included participants who received at least 1 documented treatment cycle.
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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 | Erlotinib | Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants With Best Overall Response | Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD. | Analysis population included participants who received at least 2 documented treatment cycles. Missing data was not reported. | Posted | Number | percentage of participants | Up to 6 years |
|
|
|
| Secondary | Overall Survival (OS) Time | Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS. | As per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached. | Posted | Median | Full Range | months | Up to 6 years |
|
|
|
| 14 |
| 291 |
| 134 |
| 291 |
| Nausea | Gastrointestinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Diffuse alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Feeling cold | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Hyperhidrosis | General disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.1 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|
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| PD |
|