An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer

Conditions

• Nonsquamous Nonsmall Cell Neoplasm of Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erlotinib — DRUG
  Erlotinib was provided in the retail versions of the product.

Study Details

This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.

Key Dates

First listed

Jul 13, 2010

Start date

Apr 30, 2008

Status verified

Feb 2016

Primary completion

Aug 31, 2012

Completion

Aug 31, 2012

Study Design

Enrollment

347 participants (actual)

Arms

• Arm: Erlotinib
  Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.

Primary Outcome Measure

Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) [ Time Frame: Baseline to the end of the study (up to 4 years, 4 months) ]