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This multicenter, retrospective and prospective observational, cohort study will examine the effect of second-line Tarceva treatment on long response in non-small cell lung cancer (NSCLC) participants with wild type or unknown EGFR status. Participants will be observed from the start of treatment for 8 months or until death. The extension of the retrospective versus prospective observation will depend on the lag between the date of the participant enrollment and the date of beginning of erlotinib therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSCLC Participants | Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 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 sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. | Up to 8 months |
| Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. | Up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) According to RECIST v1.1 | PFS was defined as the time from the beginning of therapy with erlotinib to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with non-small cell lung cancer (NSCLC)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica | Chieti | Abruzzo | 66100 | Italy | ||
| Ospedale Civile; Divisione Di Oncologia |
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A total of 172 participants were enrolled; 16 participants had protocol violations; 156 participants were eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | NSCLC Participants | Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to 8 months |
| Overall Survival | Overall survival was defined as the time from the beginning of therapy with erlotinib to death from any cause. | Up to 8 months |
| Percentage of Participants With Adverse Events (AEs) | An AE is an unfavorable and unintended sign, symptom, or disease temporally associated with a clinical study, regardless of causality. | Up to 8 months |
| Pescara |
| Abruzzo |
| 65124 |
| Italy |
| Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica | Bari | Apulia | 70124 | Italy |
| Ospedale Vito Fazzi; Div. Oncoematologia | Lecce | Apulia | 73100 | Italy |
| Casa Sollievo della Sofferenza - Medicina Interna | San Giovanni Rotondo | Apulia | 71013 | Italy |
| Azienda Ospedaliera San Giuseppe Moscati | Avellino | Campania | 83100 | Italy |
| Az. Osp. Monaldi; 1 Pneumologia Oncologica | Naples | Campania | 80131 | Italy |
| Az. Osp. Monaldi; 2 Pneumologia-Chemioterapia E Day Hospital-Pneumoncologia | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli; U.O.C. di Oncologia Medica | Naples | Campania | 80131 | Italy |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A | Naples | Campania | 80131 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | 47014 | Italy |
| A.O. Universitaria Policlinico Di Modena; Ematologia | Modena | Emilia-Romagna | 41100 | Italy |
| A.O. Universitaria Di Parma; Oncologia Medica | Parma | Emilia-Romagna | 43100 | Italy |
| Ospedale Provinciale Santa Maria delle Croci | Ravenna | Emilia-Romagna | 48100 | Italy |
| Arcispedale Santa Maria Nuova; Oncologia | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica | Rome | Lazio | 00128 | Italy |
| Fondazione Ptv Policlinico Tor Vergata | Rome | Lazio | 00133 | Italy |
| Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica | Rome | Lazio | 00152 | Italy |
| Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1 | Rome | Lazio | 00152 | Italy |
| Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche | Rome | Lazio | 00161 | Italy |
| IFO - Istituto Regina Elena; Oncologia Medica | Rome | Lazio | 00168 | Italy |
| IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A | Genoa | Liguria | 16132 | Italy |
| A.O. Villa Scassi; Oncologia Medica | Genoa | Liguria | 16149 | Italy |
| Ospedale Valduce;U.O.S. Oncologia Ed Ematologia | Como | Lombardy | 22100 | Italy |
| Az. Osp. Carlo Poma; Divisione Di Oncologia Medica | Mantua | Lombardy | 46100 | Italy |
| ASST DI MONZA; Oncologia Medica | Monza | Lombardy | 20900 | Italy |
| Ospedale Maggiore Della Carita; Oncologia Medica | Novara | Piedmont | 28100 | Italy |
| Ospedale Oncologico A.Businco; Div. Oncologia Medica II | Cagliari | Sardinia | 09121 | Italy |
| Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica | Catania | Sicily | 95122 | Italy |
| Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello | Palermo | Sicily | 90146 | Italy |
| Ospedale Di Macerata; Oncologia | Province of Macerata | The Marches | 62100 | Italy |
| Ospedale Di Bolzano; Dept. Di Oncologia | Bolzano | Trentino-Alto Adige | 39100 | Italy |
| Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1 | Florence | Tuscany | 50139 | Italy |
| Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica | Lido di Camaiore | Tuscany | 55043 | Italy |
| Ospedale Civile; Unita Operativa Di Oncologia Medica | Livorno | Tuscany | 57100 | Italy |
| A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii | Pisa | Tuscany | 56124 | Italy |
| IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda | Padova | Veneto | 35128 | Italy |
| Ospedale Cà Foncello - Divisione di Oncologia Medica | Treviso | Veneto | 31100 | Italy |
| A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O. | Verona | Veneto | 37126 | Italy |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline analysis population included eligible participants (without protocol violations).
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| ID | Title | Description |
|---|---|---|
| BG000 | NSCLC Participants | Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 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 sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. | All eligible participants | Posted | Number | percentage of participants | Up to 8 months |
|
|
| ||||||||||||||||||||||||||
| Primary | Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. | All eligible participants | Posted | Number | percentage of participants | Up to 8 months |
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) According to RECIST v1.1 | PFS was defined as the time from the beginning of therapy with erlotinib to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. | All eligible participants | Posted | Median | 95% Confidence Interval | days | Up to 8 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from the beginning of therapy with erlotinib to death from any cause. | All eligible participants | Posted | Median | 95% Confidence Interval | months | Up to 8 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | An AE is an unfavorable and unintended sign, symptom, or disease temporally associated with a clinical study, regardless of causality. | All eligible participants | Posted | Number | percentage of participants | Up to 8 months |
|
|
Up to 8 months
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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 | NSCLC Participants | Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy. | 20 | 156 | 74 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| Brain oedema | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
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| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Intracranial hematoma | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
Non-randomness of the recruited population; investigator-determined treatment; lack of study blinding; absence of a control group; variation in clinical settings; and evaluable sample size for assessment of the secondary objectives.
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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| Participants |
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