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OpenTrials
Completed

NCT Number: NCT01194050

An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer

This observational study will investigate the tolerability and efficacy of Tarceva (erlotinib) in daily clinical practice under routine conditions in patients with locally advanced or metastatic non small cell lung cancer. Data will be collected for approximately 12 months.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Villingen-Schwenningen, 78052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with locally advanced or metastatic non-small cell lung cancer (stage IIIb or IV) with stable disease after 4 cycles of standard platinum-based first-line chemotherapy

Exclusion criteria

  • Not willing or not able to sign written informed consent form

Treatment and study plan

Primary outcomes

  1. Overall survival at 1 year

    Time frame: 12 months

Secondary outcomes

  1. Tolerability of Tarceva in daily clinical practice under routine conditions

    Time frame: 12 months

  2. Efficacy of Tarceva in daily clinical practice under routine conditions

    Time frame: 12 months

  3. Reproducibility of the results of the controlled SATURN study

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Erlotinib (Tarceva) in Routine Clinical Practice for First Line Maintenance Therapy (1LM) in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 2, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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