A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT02133508
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
- 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
- Known presence of epidermal growth factor receptor (EGFR) mutation
- Participation in a clinical trial with Tarceva during the study observation period
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Up to 8 months 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.
Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to 8 months 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.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) According to RECIST v1.1 Up to 8 months 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.
Overall Survival Up to 8 months Overall survival was defined as the time from the beginning of therapy with erlotinib to death from any cause.
Percentage of Participants With Adverse Events (AEs) Up to 8 months An AE is an unfavorable and unintended sign, symptom, or disease temporally associated with a clinical study, regardless of causality.
Trial Locations
- Locations (39)
A.O. Universitaria Policlinico Di Modena; Ematologia
🇮🇹Modena, Emilia-Romagna, Italy
Ospedale Provinciale Santa Maria delle Croci
🇮🇹Ravenna, Emilia-Romagna, Italy
Azienda Ospedaliera San Giuseppe Moscati
🇮🇹Avellino, Campania, Italy
Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
🇮🇹Chieti, Abruzzo, Italy
Az. Osp. Monaldi; 1 Pneumologia Oncologica
🇮🇹Napoli, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
🇮🇹Meldola, Emilia-Romagna, 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
A.O. Universitaria Di Parma; Oncologia Medica
🇮🇹Parma, Emilia-Romagna, Italy
Arcispedale Santa Maria Nuova; Oncologia
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
A.O. Villa Scassi; Oncologia Medica
🇮🇹Genova, Liguria, Italy
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
🇮🇹Firenze, Toscana, Italy
Ospedale Civile; Divisione Di Oncologia
🇮🇹Pescara, Abruzzo, Italy
Az. Osp. Monaldi; 2 Pneumologia-Chemioterapia E Day Hospital-Pneumoncologia
🇮🇹Napoli, Campania, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
🇮🇹Roma, Lazio, Italy
Fondazione Ptv Policlinico Tor Vergata
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
🇮🇹Roma, Lazio, Italy
IFO - Istituto Regina Elena; Oncologia Medica
🇮🇹Roma, Lazio, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
🇮🇹Genova, Liguria, Italy
Ospedale Valduce;U.O.S. Oncologia Ed Ematologia
🇮🇹Como, Lombardia, Italy
Az. Osp. Carlo Poma; Divisione Di Oncologia Medica
🇮🇹Mantova, Lombardia, Italy
Casa Sollievo della Sofferenza - Medicina Interna
🇮🇹San Giovanni Rotondo, Puglia, Italy
Ospedale Vito Fazzi; Div. Oncoematologia
🇮🇹Lecce, Puglia, Italy
Ospedale Oncologico A.Businco; Div. Oncologia Medica II
🇮🇹Cagliari, Sardegna, Italy
Ospedale CÃ Foncello - Divisione di Oncologia Medica
🇮🇹Treviso, Veneto, Italy
ASST DI MONZA; Oncologia Medica
🇮🇹Monza, Lombardia, Italy
Ospedale Maggiore Della Carita; Oncologia Medica
🇮🇹Novara, Piemonte, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
🇮🇹Bari, Puglia, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
🇮🇹Catania, Sicilia, Italy
Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
🇮🇹Palermo, Sicilia, Italy
Ospedale Di Macerata; Oncologia
🇮🇹Macerata, Marche, Italy
Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica
🇮🇹Lido Di Camaiore, Toscana, Italy
Ospedale Di Bolzano; Dept. Di Oncologia
🇮🇹Bolzano, Trentino-Alto Adige, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
🇮🇹Padova, Veneto, Italy
Ospedale Civile; Unita Operativa Di Oncologia Medica
🇮🇹Livorno, Toscana, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
🇮🇹Pisa, Toscana, Italy
A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
🇮🇹Verona, Veneto, Italy