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This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Participants received erlotinib 150 mg orally once a day for 48 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib was supplied as tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression-free Survival at Week 52 | A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter. |
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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 |
|---|---|---|---|---|---|---|
| Bangalore | 560027 | India | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants received erlotinib 150 mg orally once a day for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| From the date of enrolment until the end of the study (up to 2 years, 6 months). |
| Overall Survival | Overall survival was defined as the time from the date of enrolment to the date of death from any cause. | From the date of enrolment until the end of the study (up to 2 years, 6 months). |
| Percentage of Participants With a Complete Response (CR) or a Partial Response (PR) | A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. | From the date of enrolment until the end of the study (up to 2 years, 6 months). |
| Percentage of Participants With Disease Control | A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. | From the date of enrolment until the end of the study (up to 2 years, 6 months). |
| Chennai |
| 600035 |
| India |
| Delhi | 110085 | India |
| Hyderabad | 500 034 | India |
| Jaipur | 302 017 | India |
| Kolkata | 700026 | India |
| Nashik | 422005 | India |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants received erlotinib 150 mg orally once a day for 48 weeks. |
| 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 | Percentage of Participants With Progression-free Survival at Week 52 | A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Full analysis set: All enrolled participants. | Posted | Number | Percentage of participants | From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months). |
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| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter. | Full analysis set: All enrolled participants. | Posted | Median | 95% Confidence Interval | Days | From the date of enrolment until the end of the study (up to 2 years, 6 months). |
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| Secondary | Overall Survival | Overall survival was defined as the time from the date of enrolment to the date of death from any cause. | Full analysis set: All enrolled participants. | Posted | Median | Inter-Quartile Range | Days | From the date of enrolment until the end of the study (up to 2 years, 6 months). |
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| Secondary | Percentage of Participants With a Complete Response (CR) or a Partial Response (PR) | A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. | Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available. | Posted | Number | Percentage of participants | From the date of enrolment until the end of the study (up to 2 years, 6 months). |
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| Secondary | Percentage of Participants With Disease Control | A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. | Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available. | Posted | Number | Percentage of participants | From the date of enrolment until the end of the study (up to 2 years, 6 months). |
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Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
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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 received erlotinib 150 mg orally once a day for 48 weeks. | 4 | 51 | 32 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Convulsions | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Gastrointestinal toxicity | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acneiform rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Dyspnoea | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Generalized weakness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Maculopapular rashes | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Rashes | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | 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 |
|---|---|
| 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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| Participants |
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