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This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib [Tarceva] | Drug | 150 mg daily orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation | PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44. | Per standard of care (every 3 months) until discontinuation for up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1 | Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki | 00290 | Finland | ||||
All participants underwent EGFR mutation testing at Screening. Those positive for the EGFR mutation and who met eligibility criteria (number of participants [n] = 3) received treatment with erlotinib. The remaining participants (n = 21) were followed for overall survival but did not receive treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants positive for the epidermal growth factor receptor (EGFR) mutation and who met eligibility criteria received treatment with erlotinib, 150 milligrams (mg) orally once daily until disease progression or unacceptable toxicity. |
| FG001 | Untreated |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Per standard of care (every 3 months) until discontinuation for up to approximately 2 years |
| Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants | OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44. | Per standard of care (every 3 months) until discontinuation for up to approximately 2 years |
| Percentage of Participants Alive at 6 and 12 Months | Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100. | At 6 and 12 months |
| Percentage of Participants With EGFR Mutation at Screening | Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100. | Screening |
| Kuopio |
| 70211 |
| Finland |
| Oulu | 90029 | Finland |
| Pori | 28500 | Finland |
| Turku | 20521 | Finland |
Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival. |
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All erlotinib-treated participants who received at least one dose of erlotinib, in addition to all enrolled untreated patients, were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity. |
| BG001 | Untreated | Participants without the EGFR mutation were followed for overall survival but did not undergo treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival. |
| BG002 | Total | Total of all reporting groups |
| 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) Among Erlotinib-Treated Participants With the EGFR Mutation | PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44. | All Participants Treated: All participants who received at least one dose of erlotinib were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Per standard of care (every 3 months) until discontinuation for up to approximately 2 years |
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| Secondary | Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1 | Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions. | All Participants Treated | Posted | Number | participants | Per standard of care (every 3 months) until discontinuation for up to approximately 2 years |
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| Secondary | Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants | OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44. | All Participants Enrolled: All erlotinib-treated participants who received at least one dose of erlotinib, in addition to all enrolled untreated participants, were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Per standard of care (every 3 months) until discontinuation for up to approximately 2 years |
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| Secondary | Percentage of Participants Alive at 6 and 12 Months | Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100. | All Participants Enrolled | Posted | Number | percentage of participants | At 6 and 12 months |
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| Secondary | Percentage of Participants With EGFR Mutation at Screening | Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100. | All Participants Enrolled | Posted | Number | 95% Confidence Interval | percentage of participants | Screening |
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Up to 2 years
Only participants treated with erlotinib were assessed for adverse events.
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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 positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity. | 1 | 3 | 2 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epidural catheter infection | Infections and infestations | NCI CTC-AE v4.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC-AE v4.0 | Non-systematic Assessment |
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| Bleeding from mouth | Gastrointestinal disorders | NCI CTC-AE v4.0 | Non-systematic Assessment |
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| Eye infection | Infections and infestations | NCI CTC-AE v4.0 | Non-systematic Assessment |
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| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTC-AE v4.0 | Non-systematic Assessment |
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| Periosteal reaction | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTC-AE v4.0 | Non-systematic Assessment |
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| Paraparesis | Nervous system disorders | NCI CTC-AE v4.0 | 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-LaRoche | 800-821-8590 | genentech@druginfo.com |
| 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 |
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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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