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

Roche

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02133508

ML28891

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

172 participants in 1 patient group

NSCLC Participants

Description:

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.