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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017063-42 |
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This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Participants will receive 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib 150 mg oral doses will be administered daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Analysis was performed using Kaplan-Meier method. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. | Baseline up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1 | Time to disease progression was defined as the time from baseline evaluation to the first date PD was recorded. Participants without progression were censored at the date of last tumor assessment where non-progression was documented. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new 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 |
|---|---|---|---|---|---|---|
| County Hospital Alba; Oncology | Alba Iulia | 510073 | Romania | |||
| Institut of Oncology Al. Trestioreanu Bucharest; Oncology |
Ninety participants were screened and 23 participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants received 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline up to approximately 4 years |
| Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1 | CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to baseline. | Baseline up to approximately 4 years |
| Percentage of Participants Who Were Alive One Year After Study Treatment Initiation | Year 1 |
| Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1 | PD was assessed using RECIST v1.1. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Percentage of participants by localization of PD were reported. Localization included: Left lung inferior lobe; Para-aortic; Left lung upper lobe; Right lung inferior lobe; and Infracranial. | Baseline up to approximately 4 years |
| Number of EGFR Positive Participants Classified Based on Smoking Status | Participants were asked: "Have you smoked at least 100 cigarettes in your entire life?" and "Do you now smoke cigarettes every day, some days, or not at all?" Responses were grouped into three categories: Current Smoker, Former Smoker, and Non-Smoker. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of survey, smoked either every day or some days were defined as 'Current smoker'. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of the survey, did not smoke at all were defined as 'Former smoker'. Participants who reported never having smoked 100 cigarettes were defined as 'Non-smoker'. | Day 1 |
| Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations | Participants with NSCLC have tumor associated with EGFR mutations. These mutations occur within EGFR Exons 18-21, which encodes a portion of the EGFR kinase domain. | Day 1 |
| Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples | Baseline up to approximately 4 years |
| Bucharest |
| 022328 |
| Romania |
| Institute Of Oncology Bucharest; Medical Oncology | Bucharest | 022338 | Romania |
| Spitalul de Boli Cronice Sf. Luca | Bucharest | 04195 | Romania |
| Emergency University Bucharest Hospital; Oncology Department | Bucharest | 050098 | Romania |
| Oncology Inst. Cluj-Napoca; Cancer Dept | Cluj-Napoca | 400015 | Romania |
| Uni Hospital St. Spiridon; Clinica Oncologie-Radiotherapie | Iași | 6600 | Romania |
| S.C. Life Search S.R.L; Medical Oncology Clinic | Timișoara | 300167 | Romania |
| ONCOMED - Medical Centre | Timișoara | 300239 | Romania |
| COMPLETED |
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| NOT COMPLETED |
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Analysis population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death. |
| 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), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Analysis was performed using Kaplan-Meier method. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. | All enrolled participants. | Posted | Median | 95% Confidence Interval | days | Baseline up to approximately 4 years |
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| Secondary | Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1 | Time to disease progression was defined as the time from baseline evaluation to the first date PD was recorded. Participants without progression were censored at the date of last tumor assessment where non-progression was documented. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. | All enrolled participants. | Posted | Median | 95% Confidence Interval | days | Baseline up to approximately 4 years |
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| Secondary | Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1 | CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to baseline. | All enrolled participants. | Posted | Number | percentage of participants | Baseline up to approximately 4 years |
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| Secondary | Percentage of Participants Who Were Alive One Year After Study Treatment Initiation | All enrolled participants with available data for this outcome. | Posted | Number | percentage of participants | Year 1 |
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| Secondary | Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1 | PD was assessed using RECIST v1.1. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Percentage of participants by localization of PD were reported. Localization included: Left lung inferior lobe; Para-aortic; Left lung upper lobe; Right lung inferior lobe; and Infracranial. | All enrolled participants with available data for this outcome. | Posted | Number | percentage of participants | Baseline up to approximately 4 years |
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| Secondary | Number of EGFR Positive Participants Classified Based on Smoking Status | Participants were asked: "Have you smoked at least 100 cigarettes in your entire life?" and "Do you now smoke cigarettes every day, some days, or not at all?" Responses were grouped into three categories: Current Smoker, Former Smoker, and Non-Smoker. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of survey, smoked either every day or some days were defined as 'Current smoker'. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of the survey, did not smoke at all were defined as 'Former smoker'. Participants who reported never having smoked 100 cigarettes were defined as 'Non-smoker'. | All enrolled participants. | Posted | Number | participants | Day 1 |
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| Secondary | Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations | Participants with NSCLC have tumor associated with EGFR mutations. These mutations occur within EGFR Exons 18-21, which encodes a portion of the EGFR kinase domain. | All enrolled participants. | Posted | Number | participants | Day 1 |
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| Secondary | Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples | No participants were analyzed for this outcome as no plasma samples were collected during the study. | Posted | Baseline up to approximately 4 years |
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Baseline up to approximately 4 years
Safety analysis population included all participants who receive at least one dose of treatment and had at least one monthly assessment.
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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 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death. | 5 | 23 | 15 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemiparesis | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Brain neoplasm malignant | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Ischemic stroke | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vaginal hemorrhages | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Syncope | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Menorrhagia | Endocrine disorders | MedDRA (Unspecified) | 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 |
|---|---|
| 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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| Title | Denominators | Categories | ||||
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| Exon 19 deletions |
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| Exon 21 L858R mutations |
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