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

Completed

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

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

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): Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
🇮🇹
Chieti, Abruzzo, Italy
Ospedale Civile; Divisione Di Oncologia
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Pescara, Abruzzo, Italy
Azienda Ospedaliera San Giuseppe Moscati
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Avellino, Campania, Italy
Az. Osp. Monaldi; 1 Pneumologia Oncologica
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Napoli, Campania, Italy
Az. Osp. Monaldi; 2 Pneumologia-Chemioterapia E Day Hospital-Pneumoncologia
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Napoli, Campania, Italy
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli; U.O.C. di Oncologia Medica
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Napoli, Campania, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
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Napoli, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
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Meldola, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia
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Modena, Emilia-Romagna, Italy
A.O. Universitaria Di Parma; Oncologia Medica
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Parma, Emilia-Romagna, Italy
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Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
🇮🇹Chieti, Abruzzo, Italy