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This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib 150 mg | Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib 150 mg | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the time from initial dose of erlotinib to progression or death from any cause. | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response | Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions. | Approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer, with ECOG performance status of 0-1
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Center of Serbia; Institute For Pulmology | Belgrade | 11000 | Serbia | |||
| Institute for Oncology and Radiology of Serbia; Medical Oncology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib 150 mg | Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease. | Baseline up to 3 years |
| Belgrade |
| 11000 |
| Serbia |
| Military Medical Academy; Clinic for Pulmonology | Belgrade | 11000 | Serbia |
| Institute for pulmonary diseases of Vojvodina | Kamenitz | 21204 | Serbia |
| Clinical Center Nis; Clinic for pulmonary diseases Knez Selo | Knez-Selo | 18000 | Serbia |
| COMPLETED |
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| NOT COMPLETED |
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Baseline analysis population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib 150 mg | Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | PFS was defined as the time from initial dose of erlotinib to progression or death from any cause. | The effectiveness analysis population included all enrolled participants in the study. | Posted | Median | 95% Confidence Interval | months | Approximately 3 years |
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| Secondary | Percentage of Participants With Overall Response | Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions. | The effectiveness analysis population included all enrolled participants in the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | Approximately 3 years |
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| Secondary | Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease. | The safety analysis population included all enrolled participants who received a single dose of erlotinib. | Posted | Number | 95% Confidence Interval | Proportion of participants | Baseline up to 3 years |
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Baseline up to 3 years
All enrolled participants were included in the safety population.
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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 150 mg | Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years. | 19 | 70 | 21 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Disease progression | General disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Sudden death | General disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v.19.1 | Non-systematic Assessment |
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| Infectious pleural effusion | Infections and infestations | MedDRA v.19.1 | Non-systematic Assessment |
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| Conjuctivitis | Infections and infestations | MedDRA v.19.1 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA v.19.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v.19.1 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA v.19.1 | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA v.19.1 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA v.19.1 | Non-systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Superior vena cava syndrome | Vascular disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v.19.1 | Non-systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA v.19.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v.19.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| 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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