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This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) participants treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate at Month 6 | Month 6 | |
| Survival Rate at Month 12 | Month 12 | |
| Progression Free Survival (PFS) at Month 6 | PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines. | From inclusion up to disease progression or death whichever occurs first (up to 6 months) |
| Progression Free Survival (PFS) at Month 12 | PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines. | From inclusion up to disease progression or death whichever occurs first (up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as time from first administration of study drug until death from any cause. | Up to 12 months |
| Percentage of Participants With Adverse Events (AEs) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
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Inclusion Criteria:
Exclusion Criteria:
- Unknown EGFR mutation status
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Adult participants diagnosed with locally advanced, metastatic or recurrent non-small cell lung carcinoma with wild-type EGFR.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucharest | 022338 | Romania |
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A total of 33 participants were enrolled in 13 centers in Romania.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis was performed on all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Survival Rate at Month 6 | Analysis was performed on all enrolled participants. | Posted | Number | percentage of participants | Month 6 |
|
|
Up to 12 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 | Erlotinib | Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischaemic limb pain | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
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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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| Up to 12 months |
| Overall Survival According to Prior Chemotherapy Treatment. | Prior chemotherapy treatment is presented as reported by the investigators. | Up to 12 months |
| Disease Progression (PD) |
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| PD Before Treatment Start |
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| Dossier not Approved |
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| Lost to Follow-up |
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| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Survival Rate at Month 12 | Analysis was performed on all enrolled participants. | Posted | Number | percentage of participants | Month 12 |
|
|
|
| Primary | Progression Free Survival (PFS) at Month 6 | PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines. | Analysis was performed on all enrolled participants. | Posted | Median | 95% Confidence Interval | days | From inclusion up to disease progression or death whichever occurs first (up to 6 months) |
|
|
|
| Primary | Progression Free Survival (PFS) at Month 12 | PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines. | Analysis was performed on all enrolled participants. | Posted | Median | 95% Confidence Interval | days | From inclusion up to disease progression or death whichever occurs first (up to 12 months) |
|
|
|
| Secondary | Overall Survival (OS) | OS is defined as time from first administration of study drug until death from any cause. | Analysis was performed on all enrolled participants. | Posted | Mean | Standard Error | days | Up to 12 months |
|
|
|
| Secondary | Percentage of Participants With Adverse Events (AEs) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Analysis was performed on all enrolled participants. | Posted | Number | percentage of participants | Up to 12 months |
|
|
|
| Secondary | Overall Survival According to Prior Chemotherapy Treatment. | Prior chemotherapy treatment is presented as reported by the investigators. | Analysis was performed on all enrolled participants. | Posted | Mean | Standard Error | days | Up to 12 months |
|
|
|
| 7 |
| 33 |
| 3 |
| 33 |
| Blood bilirubin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Disease progression | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Pleural neoplasms | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | 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.
| Title | Measurements |
|---|---|
|
| Carboplatin & Alimta (n=1) |
|
| Carboplatin & Vinorelbine (n=1) |
|
| Carboplatin & Docetaxel (n=2) |
|
| Carboplatin & Paclitaxel (n=4) |
|
| Docetaxel, Gemcitabine & Cisplatin (n=1) |
|
| Cisplatin & Paclitaxel (n=2) |
|
| Docetaxel (n=1) |
|
| Gemcitabine (n=1) |
|
| Gemzar & Carboplatine (n=3) |
|
| Paclitaxel & carboplatin (CBDCA) (n=1) |
|
| Taxol & Carboplatin (n=1) |
|
| Taxotere (n=1) |
|