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OpenTrials
Completed

NCT Number: NCT01488331

An Observational Study of Tarceva (Erlotinib) in Patients With Non-Small Cell Lung Cancer

This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 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

Abbeville, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/=18 years of age
  • Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC, stage III/IV)
  • Treatment with Tarceva monotherapy and not progressing after at least 9 months at the date of study start

Exclusion criteria

  • Not agreeing to be followed-up (for a maximum of 24 months)

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: 24 months

Secondary outcomes

  1. Best treatment response

    Time frame: 24 months

  2. Overall survival

    Time frame: 24 months

  3. Safety (incidence of adverse events)

    Time frame: 24 months

  4. Type of treatment response

    Time frame: 24 months

  5. Treatment compliance of patient

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Patient Cohort With Locally Advanced or Metastatic Non-small Cell Lung Cancer Treated With Tarceva (Erlotinib) Monotherapy and Not Progressing After at Least 9 Months

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 8, 2011
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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