An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy

Sponsor
Hoffmann-La Roche
Study ID
NCT01664533
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Erlotinib was supplied as tablets in the retail product Tarceva.

Study Details

This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.

Key Dates

First listed
Aug 14, 2012
Start date
Sep 30, 2011
Status verified
Nov 2015
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
57 participants (actual)

Arms

  • Arm: Erlotinib
    Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 2 years) ]

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