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A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)

NCT ID: NCT02133508

Last Updated: 2017-10-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-06-10

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica

Chieti, Abruzzo, Italy

Site Status

Ospedale Civile; Divisione Di Oncologia

Pescara, Abruzzo, Italy

Site Status

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

Bari, Apulia, Italy

Site Status

Ospedale Vito Fazzi; Div. Oncoematologia

Lecce, Apulia, Italy

Site Status

Casa Sollievo della Sofferenza - Medicina Interna

San Giovanni Rotondo, Apulia, Italy

Site Status

Azienda Ospedaliera San Giuseppe Moscati

Avellino, Campania, Italy

Site Status

Az. Osp. Monaldi; 1 Pneumologia Oncologica

Napoli, Campania, Italy

Site Status

Az. Osp. Monaldi; 2 Pneumologia-Chemioterapia E Day Hospital-Pneumoncologia

Napoli, Campania, Italy

Site Status

Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli; U.O.C. di Oncologia Medica

Napoli, Campania, Italy

Site Status

IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A

Napoli, Campania, Italy

Site Status

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

Meldola, Emilia-Romagna, Italy

Site Status

A.O. Universitaria Policlinico Di Modena; Ematologia

Modena, Emilia-Romagna, Italy

Site Status

A.O. Universitaria Di Parma; Oncologia Medica

Parma, Emilia-Romagna, Italy

Site Status

Ospedale Provinciale Santa Maria delle Croci

Ravenna, Emilia-Romagna, Italy

Site Status

Arcispedale Santa Maria Nuova; Oncologia

Reggio Emilia, Emilia-Romagna, Italy

Site Status

Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

Rome, Lazio, Italy

Site Status

Fondazione Ptv Policlinico Tor Vergata

Rome, Lazio, Italy

Site Status

Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

Rome, Lazio, Italy

Site Status

Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

Rome, Lazio, Italy

Site Status

Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

Rome, Lazio, Italy

Site Status

IFO - Istituto Regina Elena; Oncologia Medica

Rome, Lazio, Italy

Site Status

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

Genoa, Liguria, Italy

Site Status

A.O. Villa Scassi; Oncologia Medica

Genoa, Liguria, Italy

Site Status

Ospedale Valduce;U.O.S. Oncologia Ed Ematologia

Como, Lombardy, Italy

Site Status

Az. Osp. Carlo Poma; Divisione Di Oncologia Medica

Mantova, Lombardy, Italy

Site Status

ASST DI MONZA; Oncologia Medica

Monza, Lombardy, Italy

Site Status

Ospedale Maggiore Della Carita; Oncologia Medica

Novara, Piedmont, Italy

Site Status

Ospedale Oncologico A.Businco; Div. Oncologia Medica II

Cagliari, Sardinia, Italy

Site Status

Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

Catania, Sicily, Italy

Site Status

Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello

Palermo, Sicily, Italy

Site Status

Ospedale Di Macerata; Oncologia

Macerata, The Marches, Italy

Site Status

Ospedale Di Bolzano; Dept. Di Oncologia

Bolzano, Trentino-Alto Adige, Italy

Site Status

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Florence, Tuscany, Italy

Site Status

Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

Lido di Camaiore, Tuscany, Italy

Site Status

Ospedale Civile; Unita Operativa Di Oncologia Medica

Livorno, Tuscany, Italy

Site Status

A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

Pisa, Tuscany, Italy

Site Status

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

Padua, Veneto, Italy

Site Status

Ospedale Cà Foncello - Divisione di Oncologia Medica

Treviso, Veneto, Italy

Site Status

A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

Verona, Veneto, Italy

Site Status

Countries

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Italy

Other Identifiers

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ML28891

Identifier Type: -

Identifier Source: org_study_id