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Completed

NCT Number: NCT01659970

PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 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

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
  • Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy
  • Patients for whom the treating physician has decided to initiate treatment with Tarceva

Exclusion criteria

  • Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component
  • Current participation in a clinical trial evaluating an anticancer treatment

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: 2 years

Secondary outcomes

  1. Clinical/demographic patients characteristics at baseline

    Time frame: 2 years

  2. Treatment schedules: Dose/duration/modifications/interruptions

    Time frame: 2 years

  3. Overall survival

    Time frame: 2 years

  4. Safety: Incidence of adverse events

    Time frame: 2 years

  5. Quality of life: FACT-L version 4 questionnaire

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2012
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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