An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)

Sponsor
Hoffmann-La Roche
Study ID
NCT01836133
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

Study Details

This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.

Key Dates

First listed
Apr 19, 2013
Start date
May 31, 2013
Status verified
Mar 2017
Primary completion
Jan 31, 2016
Completion
Jan 31, 2016

Study Design

Enrollment
70 participants (actual)

Arms

  • Arm: Erlotinib 150 mg
    Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Approximately 3 years ]

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