Non-Small Cell Lung Cancer Clinical Trial
Official title:
Observational Trial on Long Responses in Patients With Advanced Non-Small Cell Lung Cancer Treated in Second-Line With Erlotinib
Verified date | May 2017 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | June 10, 2016 |
Est. primary completion date | June 10, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Participants with stage IIIb or IV NSCLC - Participants aged >/= 18 years - Second-line treatment with Tarceva started before study inclusion and SD response, or CR/PR according to RECIST v1.1, lasting for at least 4 weeks Exclusion Criteria: - Known presence of epidermal growth factor receptor (EGFR) mutation - Participation in a clinical trial with Tarceva during the study observation period |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera San Giuseppe Moscati | Avellino | Campania |
Italy | Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica | Bari | Puglia |
Italy | Ospedale Di Bolzano; Dept. Di Oncologia | Bolzano | Trentino-Alto Adige |
Italy | Ospedale Oncologico A.Businco; Div. Oncologia Medica II | Cagliari | Sardegna |
Italy | Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica | Catania | Sicilia |
Italy | Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica | Chieti | Abruzzo |
Italy | Ospedale Valduce;U.O.S. Oncologia Ed Ematologia | Como | Lombardia |
Italy | Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1 | Firenze | Toscana |
Italy | A.O. Villa Scassi; Oncologia Medica | Genova | Liguria |
Italy | IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A | Genova | Liguria |
Italy | Ospedale Vito Fazzi; Div. Oncoematologia | Lecce | Puglia |
Italy | Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica | Lido Di Camaiore | Toscana |
Italy | Ospedale Civile; Unita Operativa Di Oncologia Medica | Livorno | Toscana |
Italy | Ospedale Di Macerata; Oncologia | Macerata | Marche |
Italy | Az. Osp. Carlo Poma; Divisione Di Oncologia Medica | Mantova | Lombardia |
Italy | IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna |
Italy | A.O. Universitaria Policlinico Di Modena; Ematologia | Modena | Emilia-Romagna |
Italy | ASST DI MONZA; Oncologia Medica | Monza | Lombardia |
Italy | Az. Osp. Monaldi; 1 Pneumologia Oncologica | Napoli | Campania |
Italy | Az. Osp. Monaldi; 2 Pneumologia-Chemioterapia E Day Hospital-Pneumoncologia | Napoli | Campania |
Italy | Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli; U.O.C. di Oncologia Medica | Napoli | Campania |
Italy | IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A | Napoli | Campania |
Italy | Ospedale Maggiore Della Carita; Oncologia Medica | Novara | Piemonte |
Italy | IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda | Padova | Veneto |
Italy | Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello | Palermo | Sicilia |
Italy | A.O. Universitaria Di Parma; Oncologia Medica | Parma | Emilia-Romagna |
Italy | Ospedale Civile; Divisione Di Oncologia | Pescara | Abruzzo |
Italy | A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii | Pisa | Toscana |
Italy | Ospedale Provinciale Santa Maria delle Croci | Ravenna | Emilia-Romagna |
Italy | Arcispedale Santa Maria Nuova; Oncologia | Reggio Emilia | Emilia-Romagna |
Italy | Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica | Roma | Lazio |
Italy | Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1 | Roma | Lazio |
Italy | Fondazione Ptv Policlinico Tor Vergata | Roma | Lazio |
Italy | IFO - Istituto Regina Elena; Oncologia Medica | Roma | Lazio |
Italy | Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche | Roma | Lazio |
Italy | Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica | Roma | Lazio |
Italy | Casa Sollievo della Sofferenza - Medicina Interna | San Giovanni Rotondo | Puglia |
Italy | Ospedale Cà Foncello - Divisione di Oncologia Medica | Treviso | Veneto |
Italy | A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O. | Verona | Veneto |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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. | 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. | 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. | 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. | Up to 8 months |
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