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Completed

NCT Number: NCT01790217

An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 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

Oldenburg, 26121, Germany

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
  • Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer
  • Patients for whom the treating physician has decided to initiate first-line therapy with Tarceva in accordance with the Summary of Product Characteristics and local guidelines

Exclusion criteria

  • N/A

Treatment and study plan

Primary outcomes

  1. Progression-free survival rate at 18 months

    Time frame: 3.5 years

Secondary outcomes

  1. Response rate (complete response/partial response) by type of mutation

    Time frame: 3.5 years

  2. Percentage of patients with remission

    Time frame: 3.5 years

  3. Progression-free survival (overall/stratified)

    Time frame: 3.5 years

  4. Overall survival (overall/stratified)

    Time frame: 3.5 years

  5. Tolerability: Incidence of fatigue, rash, diarrhea

    Time frame: 3.5 years

  6. Safety: Incidence of serious adverse events

    Time frame: 3.5 years

  7. Dose modifications/withdrawals

    Time frame: 3.5 years

  8. Symptom control (cough, dyspnea)

    Time frame: 3.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

GERMAN TARCEVA NON-INTERVENTIONAL STUDY in 1st Line Treatment of NSCLC EGFR Mutation Positive Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2013
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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