Clinical trial NCT02133508: A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)
Official title: Observational Trial on Long Responses in Patients With Advanced Non-Small Cell Lung Cancer Treated in Second-Line With Erlotinib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-05-08
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with non-small cell lung cancer (NSCLC)

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 8 months
measure: Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to 8 months
Secondary outcomes:
measure: Progression-free Survival (PFS) According to RECIST v1.1
timeFrame: Up to 8 months
measure: Overall Survival
timeFrame: Up to 8 months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 8 months
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
state: Abruzzo
city: Pescara
country: Italy
facility: Ospedale Civile; Divisione Di Oncologia
state: Abruzzo
city: Avellino
country: Italy
facility: Azienda Ospedaliera San Giuseppe Moscati
state: Campania
city: Napoli
country: Italy
facility: Az. Osp. Monaldi; 1 Pneumologia Oncologica
state: Campania
city: Napoli
country: Italy
facility: Az. Osp. Monaldi; 2 Pneumologia-Chemioterapia E Day Hospital-Pneumoncologia
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli; U.O.C. di Oncologia Medica
state: Campania
city: Napoli
country: Italy
facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
state: Campania
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Ematologia
state: Emilia-Romagna
city: Parma
country: Italy
facility: A.O. Universitaria Di Parma; Oncologia Medica
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Ospedale Provinciale Santa Maria delle Croci
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Oncologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
state: Lazio
city: Roma
country: Italy
facility: Fondazione Ptv Policlinico Tor Vergata
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
state: Lazio
city: Roma
country: Italy
facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
state: Lazio
city: Roma
country: Italy
facility: IFO - Istituto Regina Elena; Oncologia Medica
state: Lazio
city: Genova
country: Italy
facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
state: Liguria
city: Genova
country: Italy
facility: A.O. Villa Scassi; Oncologia Medica
state: Liguria
city: Como
country: Italy
facility: Ospedale Valduce;U.O.S. Oncologia Ed Ematologia
state: Lombardia
city: Mantova
country: Italy
facility: Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Oncologia Medica
state: Lombardia
city: Macerata
country: Italy
facility: Ospedale Di Macerata; Oncologia
state: Marche
city: Novara
country: Italy
facility: Ospedale Maggiore Della Carita; Oncologia Medica
state: Piemonte
city: Bari
country: Italy
facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
state: Puglia
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi; Div. Oncoematologia
state: Puglia
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza - Medicina Interna
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Oncologico A.Businco; Div. Oncologia Medica II
state: Sardegna
city: Catania
country: Italy
facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
state: Sicilia
city: Palermo
country: Italy
facility: Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
state: Toscana
city: Lido Di Camaiore
country: Italy
facility: Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica
state: Toscana
city: Livorno
country: Italy
facility: Ospedale Civile; Unita Operativa Di Oncologia Medica
state: Toscana
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
state: Toscana
city: Bolzano
country: Italy
facility: Ospedale Di Bolzano; Dept. Di Oncologia
state: Trentino-Alto Adige
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
state: Veneto
city: Treviso
country: Italy
facility: Ospedale Cà Foncello - Divisione di Oncologia Medica
state: Veneto
city: Verona
country: Italy
facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: