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This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity. |
|
| Diagnostic Phase | No Intervention | Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Daily oral doses administered until disease progression or unacceptable toxicity or death. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) | Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact. | Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Objective Response as Assessed by RECIST v 1.1 | Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
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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 |
|---|---|---|---|---|---|---|
| Clinic for Pulmonology, Clinical Center of Serbia | Belgrade | 11000 | Serbia | |||
| Clinical Center Bezanijska Kosa; Oncology |
375 participants were in the diagnostic population. Out of the 375 participants, only 30 participants had EGFR mutation and were eligible for erlotinib treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic Phase | Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study. |
| FG001 | Erlotinib | Erlotinib was administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Diagnostic Phase |
|
| ||||||||||||||||||
| Erlotinib Phase |
|
The intent-to-treat (ITT) population included all participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Population | Participants with advanced or metastatic NSCLC were tested for EGFR mutations and enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 375 participants were in the diagnostic population. Out of the 375 participants, only 30 participants had EGFR mutation and were eligible for erlotinib treatment. |
| 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 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) | Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact. | The intent-to-treat population included all participants enrolled in the study. There were no patients excluded from analysis either in efficacy and safety analysis. | Posted | Median | 95% Confidence Interval | months | Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) |
|
4 years and 9 months
The safety population was identical to the ITT population. The ITT population comprised all 30 patients.
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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 | Erlotinib was administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2012 | Aug 22, 2018 | Prot_SAP_000.pdf |
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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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| Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) |
| Proportion of Participants With Disease Control as Assessed by RECIST v 1.1 | Disease control was defined as objective response or stable disease (SD) for at least 6 weeks. OR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of CR and PR four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) |
| Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations | Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21. | Screening up to approximately 7 days |
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to approximately 4 years and 9 months |
| Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L) | The domains in the Quality of life score using the Functional Assessment of Cancer Therapy Lung (FACT-L) include physical, social/family, emotional, and functional well-being, and a lung cancer subscale include symptoms, cognitive function and regret of smoking. Minimum and maximum value of the scale is 0 and 4, respectively. Higher score indicate better health state. | Baseline and end of study (approximately 4 years and 9 months) |
| Belgrade |
| 11080 |
| Serbia |
| Institute for pulmonary diseases of Vojvodina | Kamenitz | 21204 | Serbia |
| Clinical Center Nis; Clinic for pulmonary diseases Knez Selo | Niš | Serbia |
| NOT COMPLETED |
|
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 375 participants were in the diagnostic population. Out of the 375 participants, only 30 participants had EGFR mutation and were eligible for erlotinib treatment. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 375 participants were in the diagnostic population. Out of the 375 participants, only 30 participants had EGFR mutation and were eligible for erlotinib treatment. | Count of Participants | Participants |
|
| OG000 | Erlotinib | Erlotinib was administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity. |
|
|
| Secondary | Proportion of Participants With Objective Response as Assessed by RECIST v 1.1 | Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The intent-to-treat population included all participants enrolled in the study. There were no patients excluded from analysis either in efficacy and safety analysis. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) |
|
|
|
| Secondary | Proportion of Participants With Disease Control as Assessed by RECIST v 1.1 | Disease control was defined as objective response or stable disease (SD) for at least 6 weeks. OR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of CR and PR four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | The intent-to-treat population included all participants enrolled in the study. There were no patients excluded from analysis either in efficacy and safety analysis. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) |
|
|
|
| Secondary | Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations | Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21. | This study had 2 phases: 1st phase - included 375 patients assessed for EGFR mutations 30 patients (out of these 375) had EGFR mutations and they were included in 2nd phase - treatment with Erlotinib. | Posted | Number | 95% Confidence Interval | proportion of participants | Screening up to approximately 7 days |
|
|
|
| Secondary | Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The safety population was identical to the ITT population, which included all participants enrolled in the study. | Posted | Number | percentage of participants | Baseline up to approximately 4 years and 9 months |
|
|
|
| Secondary | Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L) | The domains in the Quality of life score using the Functional Assessment of Cancer Therapy Lung (FACT-L) include physical, social/family, emotional, and functional well-being, and a lung cancer subscale include symptoms, cognitive function and regret of smoking. Minimum and maximum value of the scale is 0 and 4, respectively. Higher score indicate better health state. | Participants without disease progression who filled out the FACT-L questionnaire. | Posted | Mean | Standard Deviation | unit on a scale | Baseline and end of study (approximately 4 years and 9 months) |
|
|
|
| 1 |
| 30 |
| 6 |
| 30 |
| 22 |
| 30 |
| Paronychia | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA, version 21.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA, version 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA, version 21.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA, version 21.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA, version 21.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA, version 21.0 | Systematic Assessment |
|
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 |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|