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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133508
• Other study ID #: ML28891
• Status: Completed
• Phase: N/A
• First received: May 7, 2014
• Last updated: May 31, 2017
• Start date: April 30, 2014
• Est. completion date: June 10, 2016

Study information

• Verified date: May 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

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